Changes by Health Canada – Where do you stand?

By Rupika Malhotra, MSc
Food, Scientific and Regulatory Affairs Associate

Recently, the Food Directorate and the Natural Health Products Directorate have made announcements with regards to new categorization of certain products such as caffeinated energy drinks and food-like NHP’s to foods. The reason for the shift is said to be the fact that several products currently regulated as Natural Health Products (NHPs) are packaged, perceived and consumed by the end users as foods. Consequently, these products should then be regulated by and adhere to the legislations associated with foods.

The most common question many companies and businesses are left asking is, where do their products stand in light of these recent policy changes. The guidance documents have indicated that all considered products will be placed into one of the three following categories:

  • NHPs that can be foods with no regulatory changes required
  • NHPs that require regulatory changes but do not require reformulations to be considered foods
  • NHPs that require regulatory changes and reformulation in order to comply with food regulations.

Health Canada has provided guidance in that NHPs sold as juice, drinks, water, energy drinks, protein products, bars, teas, wafers, gums, gels and/or soups are to submit a Temporary Marketing Authorization (TMA) application. The assessment and approval of a TMA will grant the applicant with a Temporary Marketing Authorization Letter (TMAL), giving access to the market for a specific time frame (2 to 5 years) in which research, collected data and reports will be submitted to Health Canada. It should be noted that TMAs and consequently TMALs will only be issued for products which contain ingredients prohibited under the Food and Drug Regulations and which require additional research such as added vitamins, minerals and novel ingredients not considered to have a history of safe use in Canada. For products that have approved ingredients, adjustments to labels seem to be the only regulatory requirement needed to be fulfilled.

Health Canada is moving ahead with the transition process with what they believe are three guiding principles, outlined as follows: – risk-based approach to protecting health and safety – minimal disruption to the stream of commerce and – procedural fairness and transparency. Keeping this in mind, the impact of this transition and the requirement to meet criteria set out by Health Canada in order to be compliant is yet to be seen. Past regulation and policy changes have shed light to what seems to be a fairly vocal and active Natural Health Products industry. While some argue that the transition will reduce costs of production and testing in the long run, others point out that complying with the rigid and constricting Canadian food regulations is no cake walk to begin with. Does this then mean that the already limiting regulations will further constrain innovation in the sector of natural health products and foods or, will this in contrast allow for more movement? Perhaps this is to be determined once the TMALs are granted and what if any changes are brought about in long awaited update of the Food and Drug Regulations. With this transition process companies, businesses and consumers alike wonder where they stand as food-like NHPs are transitioned to foods.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

The Industry Effect on Food Regulations

By: Rupika Malhotra, MSc – Food, Scientific and Regulatory Affairs Associate
February 13, 2012

With the introduction of any new set of guidelines, regulations or changes impacting any sector of the food industry, resistance and highly aggressive responses are usually inevitable. Globally, authoritative bodies have put into place various different forms and types of regulations over the decades that have received their fair share of praises and criticisms. However, in some cases the overall industry is left wondering what the driving factor or the basis for such changes in regulations are.

Global research has brought to light several factors, some of the most obvious being advancements on several fronts such as technology leading to more research in science, nutrition, food safety, public safety, advertising and marketing ventures. One factor that is not perhaps as widely publicized, nor spoken about as often, is industry pressure. The role that major food and natural health product companies play as a whole has in the past and will continue to in the future, have a strong impact on the way regulations are up held.

Some of the most popular foods and beverages consumed presently have been a result of what seems to be industry pressure on legislative body. As highlighted by Reissig et al., 2008, “the regulation of caffeine containing beverages in the U.S. serves as an illustrative example of the complexity of the regulatory issues involved in their sale, use and promotion”.

“In 1980, citing health concerns about caffeine, the FDA proposed to eliminate caffeine from soft drinks (Food and Drug Administration, 1980). In response, soft drink manufactures justified adding caffeine to soft drinks on the basis that caffeine was a flavour enhancer (PepsiCo Inc., 1981), although the scientific basis for that claim has since been challenged (Griffiths and Vernotica, 200; Keast and Riddell, 2007). If caffeine had not been accepted as a flavour enhancer, but had been regarded as a psychoactive ingredient, soft drinks might have been regulated by the FDA as drugs. However, the FDA approved caffeine and limited the maximum caffeine content of cola-type soft drinks to 0.02% caffeine, or 71 mg/12 fluid oz (Food and Drug Adminsitration, 2003)”. (Reissig et al, 2008)

Since then, the evolution of caffeine containing beverage consumption worldwide has raised a health concern as adverse reactions and even death in some cases have occurred. Moreover, the recent announcement by Health Canada to transition caffeinated beverages to food, despite the consult of a highly accredited health panel, simply because they are being consumed as such, has raised some industry influenced theories amongst health advocates.

Recently Danone, the global probiotic leader, has expressed concerns about guidelines set to come out in the near future, that are said to impact the probiotic status and associated claims in the European Union as determined by the European Food Safety Authority (EFSA). This isn’t the first time that a major food corporation has brought to attention the difficulty it has faced in applying for and receiving an approved health claim in the European Union. EFSA has in the past and continues to be presently criticized for “setting the scientific bar too high”, resulting in only a limited list of approved health claims that can be used on food labels and advertising. As this is the argument from the business end, several health and regulatory advocates have defended EFSA and its assessment conditions with regards to health claims specifically, stating that the applications are the ones with the deficiencies (Starling, 2012).

Is EFSA and its highly criticized approach to approving health claims not fazed by the demands, remarks and overall pressure? Are other major authoritative bodies such as Health Canada and the FDA following in EFSA’s footsteps and placing a greater emphasis on scientific analysis? Or is this merely a step in the direction of harmonizing regulations on a global level, allowing the sales of products in several jurisdictions simultaneously?

With many changes to the food and natural health product regulations framework set to be down the pipeline, various key players that make up the food and beverage industry find themselves in a position to ask these questions.

References

Reissig CJ, Strain EC, Griffiths RR. Caffeinated energy drinks–a growing problem. Drug Alcohol Depend. 2009 Jan 1;99(1-3):1-10. Epub 2008 Sep 21

Starling S. Danone: “Probiotics category could disappear”. Nutraingredients.com. William Reed Business Media SAS. February 07, 2012. Accessed on: February 9, 2012. Available Online: http://www.nutraingredients.com/On-your-radar/Probiotics/Danone-Probiotics-category-could-disappear

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

dicentra Special Alert: Health Canada Announces Proposed New Approach to Regulating Caffeinated Energy Drinks

FOR IMMEDIATE RELEASE

Health Canada Announces Proposed New Approach to
Regulating Caffeinated Energy Drinks

Toronto, Canada, October 11, 2011 – On October 6, Canadian Health Minister Leona Aglukkaq announced a new approach to regulating Energy Drinks that would classify them as food products rather than Natural Health Products (NHPs). Up until now Energy Drinks have been regulated as NHPs and are not required to state nutrition information (e.g. Nutrition Facts Panel). Energy ‘shots’ which are dose-based will remain classified as NHPs.

This change in policy goes against the advice of her expert panel, formed nearly a year ago, which recommended they be classified as drugs and sold only in pharmacies. In response, Minister Aglukkaq commented, “I firmly believe that it’s up to individuals and parents to make their own decisions when it comes to what they eat and drink. Today’s announcement will ensure that parents have the information to make the best choice for themselves and their families.”

Health Canada says it intends to initiate the new food requirements as of November 1, 2011 with the assurance that “industry will be given time to adjust to these requirements (e.g. change the labelling practices).” However, it is important to note that this is currently a proposed approach and Health Canada is accepting comments from stakeholders until 12:00am EDT, November 15, 2011

A transition is expected to take 18 – 24 months once the products are deemed eligible to be sold as foods under a Temporary Marketing Authorization (TMA). To meet the requirements for a TMA companies will be subject to data collection related to the product consumption, market share and consumer complaints (incident reporting etc). The TMA is proposed to be valid for 5 years during which time Health Canada will evaluate collected data to determine if its approach for Energy Drinks needs to be modified. Companies may need to reformulate and/or relabel to meet the new requirements.

- General implications of the proposed approach include:

- No requirements for product or site licensing

- Most likely fewer warnings and contraindications needed on the label

- Limited health claims

- Tighter regulations around nutrient and caffeine addition and permitted ingredients (e.g. herbal extracts)

- Requirement for Nutrition Facts Panel on products and full compliance with Food Labelling requirements

Implications of the Composition Requirements:

- Specific requirements will be established to control the types and levels of ingredients added to Energy Drinks; for example, setting minimum and maximum limits for caffeine from all sources (natural and synthetic sources), vitamins and minerals as well as other ingredients e.g. herbal extracts. Currently under the Food Regulations, you cannot add any vitamins, minerals or amino acids to products classified as “Energy Drinks /beverages”. Health Canada will need to provide guidelines as to what will be allowed.

- A maximum concentration of 100 mg of caffeine per 250 ml in all products, not to exceed 180 mg for any single serve product (single serve containers are any containers that can’t be resealed such as a can, or any resealable container that is 591 ml or less)

- Health Canada has determined that any Energy Drink container that cannot be resealed will be treated as a single-serve container. Health Canada has determined that re-sealable containers equal to or less than 591 mL will be treated as single-serve containers.

Implications of the Labelling Requirements:

- Caffeinated Energy Drinks will be subject to all food labelling provisions such as ingredient labelling, nutrition facts panel, allergen labelling etc.

- Health Canada proposes the following additional labelling information requirements:

- The amount of caffeine from all sources in mg per container or serving size.

- A statement on the label identifying the product as a “high source of caffeine” given that an Energy Drink will be required to contain a minimum amount of caffeine that is deemed to be sufficiently high.

- A statement indicating that the product is “Not recommended for children, pregnant or breastfeeding women, and individuals sensitive to caffeine”

- The statement “Do not mix with alcohol”

- Depending on the formulation of the product, additional labelling requirements may be required.

In addition, Health Canada would prohibit the use of caffeinated Energy Drink beverages as an ingredient in pre-mixed alcoholic beverages. They would also require that industry collect data on any consumption incident associated with their products that they receive through consumer complaints. These data would be reported to Health Canada every six months.

Comments on this proposed approach may be submitted in writing, either electronically or by regular mail. If you are submitting your comments electronically, please use the term “Energy Drinks” in the subject box of your e-mail. Comments must be received by 12:00 a.m. EDT, November 15, 2011.

Mailing address:

Bureau of Policy, Regulatory and Governmental Affairs
251 Sir Frederick Banting Driveway
Tunney’s Pasture, PL: 2202E
Ottawa, Ontario K1A 0L2

E-mail address:
energydrinks-boissonsenergisantes@hc-sc.gc.ca

Dicentra will continue to monitor the situation and work on behalf of its clients and industry to develop optimal regulatory strategies moving forward.

References:
http://www.hc-sc.gc.ca/fn-an/alt_formats/pdf/legislation/pol/energy-drinks-boissons-energisantes-eng.pdf

About Dicentra

Dicentra is a leading international scientific and regulatory consulting firm with specialized expertise in the areas of natural health products, dietary supplements, foods, beverages, cosmetics and OTCs. For years, we have been helping clients resolve complex scientific issues, develop safe and effective market-leading products, and facilitate timely regulatory global approvals. Dicentra provides regulatory and scientific solutions for accelerated business growth. We can be reached at 1-866-647-3279 or at dicentra.com

Contact:

For more information please contact:

Lydia Hunziker at 416 361 3400 x 229 or email at lydia@dicentra.com

FDA Participates in Global Efforts to Protect Consumers and Patients from Unsafe Drugs on the Internet

Clara di Tella, BSc, Pharm QA
Regulatory Affairs Specialist, Dicentra

The United States Food and Drug Administration along with regulatory agencies from 80 other countries have completed the International Internet Week of Action (IIWA) supported by INTERPOL. This year’s IIWA, was called OPERATION PANGEA IV and ran from September 20 to 27. The operation was the largest Internet-based action of its kind in support of the International Medical Products Anti-Counterfeiting Taskforce. It focused on websites supplying illegal and dangerous medicines. The goal of this project was to disrupt the criminal networks and activities related to online selling of counterfeit medicinal products, and to also increase public awareness of potential safety issues and risks of purchasing medicines online. The week resulted in websites being shut down, dozens of arrests and the worldwide seizure of products worth 6.3 million USD.

During the International Week of Action, the FDA focused on websites selling unapproved drugs such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin. These unapproved drugs can be detrimental to public health. The drugs for sale on the sites were available without a prescription and not approved by the FDA.

Warning letters were sent to the website operators and notices were sent informing that the websites were in violation of United States Law. Of the 717 websites addressed in the Warning Letters, a total of 578 have been suspended or no longer offer pharmaceuticals for sale. The FDA is continuing to work with their international counterparts to address the remaining websites selling these drug products.

For further information on scientific and regulatory affairs please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

References:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm273872.htm

http://www.interpol.int/News-and-media/News-media-releases/2011/PR081

Resveratrol: Potent Antioxidant by Day, Acne Treatment by Night

Ashleigh Hampton, MSc
Scientific and Regulatory Affairs Associate, Dicentra

There have been some challenges faced while assessing the therapeutic effects of resveratrol in humans. Phase 1 clinical trials have reported that resveratrol is readily absorbed, but undergoes extensive metabolism in the liver and intestine resulting in a very low oral bioavailability of the parent compound. Furthermore, in vitro evaluations have suggested that resveratrol metabolites are themselves inactive, but may undergo beta-glucuronidase activation to become efficacious at target tissues (As reviewed by Walle, 2011).

Irrespective of the fact that in vitro evidence suggests that inactive resveratrol metabolites may become activated at target sites, the available human clinical literature has not been sufficient to support health claims for orally administered resveratrol. Alternatively, a recently published clinical trial has demonstrated the effective use of topical trans-resveratrol as a treatment for acne vulgaris.

Acne vulgaris is characterized by hyperkeratinisation resulting in obstruction of the sebaceous follicles, androgenic stimulation of the sebaceous glands and the colonization of Propionibactereum acne. It has been suggested that the associated clinical symptoms are the result of negative feedback regulation or overstimulation of the inflammatory process resulting in increased function of the sebaceous gland. The recently published study by Fabbrocini et al. (2011) aimed to assess the effects of a topical trans-resveratrol preparation in patients with inflammatory acne vulgaris.

Twenty individuals with facial acne vulgaris were recruited for a single-blind, vehicle-controlled study. Baseline severity of the acne was evaluated using 2 different assessments: 1) the Global Acne Grading System (GAGS) and 2) a skin surface biopsy to identify the average area occupied by microcomedones, lesions which are characterized by the accumulation of abnormally desquamated corneocytes and excess oil. Following baseline analysis, a 0.001% trans-resveratrol-containing hydrogel and a chemically identical placebo control were provided to the study participants. The participants were instructed to apply the resveratrol-containing gel (labelled R) to the right side of their faces and the placebo gel (labelled C) to the left side of their faces nightly for 60 days.

After 60 consecutive days of treatment, application of trans-resveratrol resulted in a 53.75% reduction from baseline GAGS score, whereas the placebo controlled group experienced a 6.1% reduction from baseline, on average. Furthermore, when compared to baseline, the average area of microcomedones was reduced 66.7% and 9.7% following treatment with resveratrol and placebo, respectively.

In summary, the results of the study suggest that a topical preparation containing 0.001% trans-resveratrol was effective in reducing the severity of acne vulgaris.

For further information on scientific and regulatory affairs please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

References:

Fabbrocini G, Staibano S, De Rosa G, Battimiello V, Fardella N, Ilardi G, La Rotonda MI, Longobardi A, Mazzella M, Siano M, Pastore F, De Vita V, Vecchione ML, Ayala F. Resveratrol-containing gel for the treatment of acne vulgaris: a single-blind, vehicle-controlled, pilot study. Am J Clin Dermatol. 2011 Apr 1;12(2):133-41. doi: 10.2165/11530630-000000000-00000.

Walle T. Bioavailability of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:9-15.

doi: 10.1111/j.1749-6632.2010.05842.x. Review.

NHPD Seeks Industry Feedback on A New Risk Based Approach to Site Licensing

William Morkel, BSc
Senior Quality Assurance and Regulatory Affairs Specialist, Dicentra

From late September to mid October the NHPD will be holding information sessions in Montreal, Toronto, Vancouver, and Halifax to update industry on new proposed changes to the current regulations governing Site Licencing and Good Manufacturing Practices. The nation-wide tour will be followed by a live webinar on October 12.

The planned changes are captured in a Concept Paper that was made public on August 29. There are 28 suggested changes in all, but the ones most likely to have the biggest impact are as follows:

  • Issuing Site Licences based on successful on-site audits (instead of the current paper-based Quality Assurance Report approach) for all domestic and foreign, manufacturers, packagers, and labellers.
  • Holding Product Licence Holders more accountable for manufacturing, packaging, labelling, importing, and testing activities that they contract out, including responsibility for ensuring product stability.
  • Requiring manufacturers and packagers to exercise greater control over raw materials
  • Requiring that Product Licence holders provide the name and address of the manufacturer, packager, labeller, and importer of the product before a product licence is issued for the product.

While these changes are still at the concept stage, they do represent a significant overhaul of the existing regulations/guidelines. Dicentra encourages industry to participate in the upcoming information sessions and to provide their feedback. Implementation of the proposals will undoubtedly reinforce product quality assurance, but will also invariably increase the costs, in terms of both time and money, of compliance. In particular, on-site inspections of domestic and foreign sites will be undertaken by third party auditors approved by the NHPD, but it is the site licence holder who will have to arrange for, and foot the bill for, these inspections.

When the proposed changes will take effect has yet to be determined, but according to NHPD insiders it will not be for at least another two to three years. Still, industry should be proactive in planning and budgeting for the new requirements.

For further information on GMPs, Site Licencing and other regulatory issues please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

The passing of Professor Norman R. Farnsworth, Renowned Medicinal Plant Researcher

News Release

To All ABC Members and Members of the Herb and Medicinal Plant Community:

It is with a heavy heart that I inform you of the passing of our dear friend and colleague, Professor Norman R. Farnsworth, on Saturday evening, September 10, per the tribute we have produced, below.

Respectfully,

Mark Blumenthal
Founder & Executive Director
American Botanical Council
Editor, HerbalGram & HerbClip

Norman R. Farnsworth, Renowned Medicinal Plant Researcher, Dies at 81

(Austin, TX) September 12, 2011. Renowned pharmacognosist and internationally-respected medicinal plant research expert, Norman R. Farnsworth, PhD, died on September 10 at a Chicago hospital. He was 81 and had been in declining health for months, suffering from long-term congestive heart failure and type 2 diabetes.

Dr. Farnsworth was born on March 23, 1930 in Massachusetts. Norman Farnsworth was a veteran of the Korean War, drafted in the US Army at age 18 in 1949. PFC Farnsworth served in the Third Infantry Division, Seventh Regimental Combat Team. Although he was seriously wounded in the winter of 1950, Farnsworth survived. Corporal Farnsworth was awarded the Korean Ribbon with Four Battle Stars, the Combat Medical Badge, and Bronze Star with a “V” device.

He received his degree in pharmacy from the Massachusetts College of Pharmacy in 1953 and his PhD in pharmacognosy, the study of drugs from natural origins (including medicinal plants, microbes, marine organisms, and fungi), from the University of Pittsburgh in 1959. At Pitt, he helped to institute a pharmacognosy PhD program at the university and was the first to chair it.

In 1970, Prof. Farnsworth left the University of Pittsburgh for a post in the College of Pharmacy at the University of Illinois at Chicago (UIC) where he served as Head of the Department of Pharmacognosy and Pharmacology from 1970-1982. At UIC, he was also Research Professor of Pharmacognosy, the Director of the Pharmacognosy Graduate Program, and Director of the World Health Organization Program for Collaborative Research in the Pharmaceutical Sciences – a multidisciplinary program which brought together, for the first time, scientists in numerous fields of medicinal plant research to collaborate on drug discovery from medicinal plants. In 1988, he was named Senior University Scholar at UIC. He held the title of Distinguished Professor of Pharmacognosy, which he received for his “scholarship, creativity and leadership” from 2001 until his death.

As head of the pharmacognosy graduate program at UIC, he had mentored more than 100 PhD and 30 MS students. He said he had “personally” mentored about 30 PhD and 5 MS graduate students as well as mentored or co-mentored 30 post-doctoral fellows.

Professor Farnsworth was an internationally-recognized scholar and initiator or co-initiator of many significant projects in the fields of pharmacognosy and medicinal plant research. Among other accomplishments, he was a founding member of the American Society of Pharmacognosy (ASP) in 1959 and a founding member of the Society for Economic Botany (1959).

In 1975, Prof. Farnsworth created the NAPralert (acronym for Natural Products Alert) Database at UIC, the world’s first computerized database of ethnobotany, chemistry, pharmacology, toxicology, and clinical trials on medicinal plants.

He also was the Principal Investigator and Director of the Botanical Dietary Supplements for Women’s Health Center at the University of Illinois at Chicago funded by the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

The author or co-author of hundreds of research papers published in peer-reviewed journals, Prof. Farnsworth co-founded the peer-reviewed journal Phytomedicine, the International Journal of Phytotherapy and Phytopharmacology, along with Professor Hildebert Wagner, PhD, at the University of Munich, who remains the journal’s editor-in-chief. This journal is now acknowledged as one of the leading scientific journals in this field.

Among many other organizations and publications with which he was involved, Prof. Farnsworth was also a co-founder of the American Botanical Council (ABC), an independent nonprofit research and education organization, and the longest-serving member of its Board of Trustees.

In 2005, the ASP renamed its annual Research Achievement Award in honor of Prof. Farnsworth in his name, given to outstanding members of the medicinal plant research community. And, in 2005, ABC established its Norman R. Farnsworth Excellence in Botanical Research Award, given to medicinal plant researchers who have made significant contributions to the field of medicinal plants and herbal dietary supplements.

In 2010, UIC also established the Norman R. Farnsworth Professor in Pharmacognosy Endowed Professorship which is chaired by Prof. Chuan-Tao Che, PhD, one of Prof. Farnsworth’s former doctoral students.

Professor Farnsworth was the recipient of numerous awards from around the world, including the SEB’s Distinguished Economic Botanist Award in 1983, as well as numerous other awards and honorary degrees.

In the 1990s, Prof. Farnsworth was a member of the Commission on Dietary Supplement Labels, a commission established by President Bill Clinton as part of the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA) to develop recommendations for the review of the quality, safety, benefits, and appropriate labeling of dietary supplements.

A larger-than-life figure, Norm Farnsworth was rarely seen without his trademark Marsh-Wheeling cigars in his mouth, even long after he was forced to give up smoking. As venues allowing smoking in public places diminished over the past two decades, Prof. Farnsworth would often be seen in a restaurant or public area with one of his cigars in his mouth, even after being admonished by waiters who told him that smoking was not permitted. Farnsworth would point out the obvious fact that he was not smoking, that the cigar was not lit, and would continue to keep the cigar in his mouth, seeming to relish the opportunity to keep walking up to the line, but not exceeding it.

He was highly-respected and admired in life and now remembered fondly by his former students, mentees, and friends. Often seen as brash and outspoken, frequently critical of other scientists and institutions which to him were guilty of producing less than acceptable work or policies, Norm Farnsworth pushed his students and all those around him to strive to the highest degree of academic and professional excellence. And underneath the brash veneer, was a man who was seen by his colleagues and students as extraordinarily generous with his time and his personal funds.

His long-time friend and colleague of 56 years, UIC Professor (ret.) Harry H.S. Fong, PhD, once said, “Everyone who has come into contact with Norman Farnsworth has a ‘Farnsworth story’ or two to tell.” Professor Fong recalled that Farnsworth, who was still working until shortly before his illness, recently noted that Fong, his former graduate student, had retired, as an example of how long Prof. Farnsworth had hoped to be able to continue his never-ending work in medicinal plant research.

Another phrase used to describe Dr. Farnsworth is the “quintessential renaissance man,” as he was so-called in an editorial in the ASP’s Journal of Natural Products by Farnsworth’s colleagues Prof. Fong, Geoffrey A. Cordell, PhD, and A. Douglas Kinghorn, PhD, JNP’s editor-in-chief: “To fully depict Farnsworth, one needs to write a book,” said Dr. Fong.

Dr. Fong shared several anecdotes about Dr. Farnsworth. One story involved Dr. Farnsworth’s propensity for cigars. “On every lab bench and in every office that Norm has spent any length of time at the University of Pittsburgh and at University of Illinois at Chicago, one will find a littering of chewed remains of Marsh Wheeling cigar butts,” said Dr. Fong. “In fact, such mementos can even be found in Munich, Germany. When he was a visiting professor in Prof. H. Wagner’s lab in 1966, I had the ‘pleasure’ of regularly mailing boxes of Marsh Wheeling cigars labeled as ‘Investigational Material: Of no commercial interest’ to the Institute in Munich.”

However, when it comes to picking out Dr. Farnsworth’s most important accomplishment, Dr. Fong could not choose: “It is not possible to pinpoint any one piece of Norm’s work as being most influential and important,” said Dr. Fong. “Rather, it is his body of work that will constitute his legacy.”

ABC Founder and Executive Director Mark Blumenthal first met Farnsworth in 1977 at the Herb Trade Association’s Herb Symposium in Santa Cruz, CA. After a decade of growing mentorship and friendship with Blumenthal, Farnsworth, along with economic botanist and ethnobotanist James A. Duke, PhD were the first to agree to help found ABC and serve on its Board of Trustees.

“Norm was a force of nature – a man with incredible energy and profound and endless commitment to the world of medicinal plant research. There is no one like him in the profession of pharmacognosy and other fields of medicinal plant research,” said Blumenthal.

“He was like a father or uncle figure to many of his 130-plus PhD students and post-docs, creating a ‘family’ of medicinal plant researchers who are now working in many institutions around. No matter how busy he was – and he carried an incredible workload not matched by many in any field of medicinal plant science – Norm would always take time to talk to students and fellow colleagues,” said Blumenthal.

“As he neared the last few years of his life and he began to disengage from many of his former associations and responsibilities, Norm still remained active on the Board of ABC, attending all on-site and teleconference meetings, asking questions about budget issues, organization, administration, policy decisions, etc. All of us on the ABC Board were – and still are – grateful for his continued association with ABC. We were amazed with his interest in and knowledge details of the organization, and his profound commitment to the success of ABC’s unique nonprofit educational mission to spread the scientific basis supporting the responsible use of herbs, medicinal plants, and phytomedicines,” said Blumenthal.

One of Farnsworth and Fong’s former students is Daniel Fabricant, PhD, now Director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration, who said that he chose UIC because of Dr. Farnsworth and his legacy there. “He’s a straight shooter, he doesn’t put on airs, and he’s very disarming. He’s easy to gravitate to because of these unique qualities,” said Dr. Fabricant. “He’s been my mentor, a hero, and a friend.”

“He has launched a thousand careers, including my own,” said Gail Mahady, PhD, a clinical pharmacognosist who also met Dr. Farnsworth during graduate school, who headed the project at UIC to produce monographs on herbal medicines for the WHO. “For that I will be eternally grateful.”

Norman Farnsworth is survived by his devoted wife Priscilla Marston Farnsworth, his brother, Bruce, and sister-in-law, Donna, of Massachusetts, a niece and nephew, and hundreds of graduate students, PhDs, post-doctoral fellows, and close colleagues who will always cherish his beloved memory.

A wake and viewing will be held at the Adams Winterfield & Sullivan Funeral Home, 4343 Main St., Downers Grove, IL on Tuesday, September 13 from 3-9pm. Memorial service for Professor Farnsworth will be held Wednesday, September 14 at 10am (9:30am viewing) at the North Shore Baptist Church, 5244 N. Lakewood Ave., Chicago, IL with funeral and burial in Lynn, Massachusetts on Friday, September 16 at 10am, at Cuffe-McGinn Funeral Home, 157 Maple St.; interment will follow at Pine Grove Cemetery.

FDA Updates – Dealing with Natural Products in a Global Market

Manushvi Chadha, BPharm, RA Cert
Regulatory Associate, Dicentra

The FDA recognizes that the production of FDA-regulated products has gone international, with more globalization on the way. Not only wholly manufactured products, but raw materials are now being imported into the USA. This significantly blurs the line between “domestic” and “international” products, throwing up regulatory challenges. The coming years will show an upward trend in such globally produced products based on growing demand and easier access.

As part of the FDA’s solution to deal with this scenario, the FDA has released their new approach to monitor the standards of imported products in a document called “Pathway to Global Product Safety and Quality” (link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OC/GlobalProductPathway/UCM259845.pdf)

The report talks about the FDA’s plans to globalize the field of regulatory affairs by partnering with regulatory bodies worldwide to improve the safety and quality of products and to make joint efforts in increasing the sharing of regulatory resources by developing international data system networks. They also want to focus on risk analysis and information technology and also aim to leverage use of third parties, industry and the public based on risk. The FDA has already been involved in collaboration with the regulatory authorities in the EU and Australia, and has been steadily increasing the number of foreign drug manufacturing inspections.

The Food Safety Modernization Act (FSMA) is another important step in this direction. There is a new anti-smuggling strategy in place to prevent foods from being smuggled into the country, authorities can now suspend registration of food facilities, and the FDA can also detain food products if they have reason to suspect adulteration or misbranding.

As part of these steps, a draft guidance has been recently released for new dietary ingredients. (link: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm)

The guidance intends to outline when a premarket safety notification is required for dietary supplements that contain NDIs and the procedure for the same. NDIs are ingredients not marketed in the USA before October 15, 1994. However, there is no list available for the ingredients that are not considered NDIs. NDIs are also required if a change in the manufacturing process alters the chemical composition or structure of an ingredient that was either marketed before Oct. 15, 1994, or has already been submitted as an NDI. Of note is the clarification made regarding synthetics and extracts. The guidance indicates that synthetic copies of a constituent or extracts of a herb / botanical are not to be considered as dietary supplements.

Dicentra is participating in the US discussion by offering a position statement to the Natural Product Association, expanding awareness of this issue through our webinars and utilizing our network with US trade associations to offer appropriate support on this matter.

For further information on regulatory and scientific issues please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for business growth you can trust. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com
References:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259848.htm
http://www.fda.gov/Food/FoodSafety/FSMA/default.htm
http://www.naturalproductsinsider.com/news/2011/07/fda-releases-ndi-draft-guidance.aspx
http://www.nutraingredients-usa.com/Regulation/FDA-on-NDI-guidance-This-is-not-a-doomsday-scenario-for-supplements-trade
http://www.nutraingredients-usa.com/Regulation/The-wait-is-over-FDA-releases-NDI-draft-guidance?nocount

Increased Life Expectancy With Vitamin D?

Increased Life Expectancy With Vitamin D?

Christopher P.F. Marinangeli, PhD, RD
Scientific Regulatory Associate, Dicentra Inc.

Everyone is talking about vitamin D – in the nutrition world anyway. Nutritional scientists, dieticians, and government agencies promote vitamin D as a nutrient that supports bone health; mostly because it increases calcium absorption and the number of “bone building” cells called osteoclasts as well as maintains healthy blood calcium levels. However, recent evidence suggests that vitamin D status can reduce the risk of cardiovascular disease, cancer, respiratory infections, respiratory diseases, tuberculosis and diabetes.

In a new study using available ecological and epidemiological data linking vitamin D status to the aforementioned diseases, Grant (2011) calculated that life expectancy can be extended ~ 2 years by increasing serum vitamin D levels from 54 nmol/L to ≥ 100 nmol/L. In addition, it was estimated that increasing circulating vitamin D levels from 50-70 nmol/L to the 105-112 nmol/L range can decrease the economic burden of disease by ~10 %, which is substantial.

Overall, Grant (2011) presents a compelling argument. After reading the author’s thorough review of the literature, which demonstrates inverse associations between vitamin D status and disease, it becomes apparent that the physiological role for vitamin D is much broader than that of bone health. For example, Grant (2011) explains that almost every cell-type in the human body has a vitamin D receptor. Moreover, vitamin D has been shown to modulate levels of cathelicidin, defensin and various cytokines that help mount immunological responses to infectious agents. However, all of the mechanisms by which vitamin D modulates the biological processes that affect the incidence of certain diseases have not been elucidated. Thus, the available epidemiological evidence that demonstrates inverse relationships between vitamin D and disease warrants further research that is focused on deciphering possible mechanisms for how vitamin D reduces disease risk.

Humans get their vitamin D in two ways. First, endogenous vitamin D can by synthesized within the skin via exposure to sun-derived ultraviolet radiation. However, given the association between sun exposure and the incidence of skin cancer, guidelines that quantify the amount of sun required to attain appropriate levels of vitamin D have not been established. Second, vitamin D is obtained from the diet, from vitamin D rich foods (i.e. fish), vitamin D supplementation, or vitamin D fortified foods (i.e. milk and some fruit juices). It should be noted that in the United States milk producers have the option of fortifying milk with ~38.5 IU vitamin D/ 100 ml milk, whereas in Canada, the fortification of milk with vitamin D is required by law at 35-45 IU vitamin D /l00 ml milk (Ross et al. 2011). Canadian and U.S. guidelines for daily vitamin D intake recommend approximately 600 IU/day vitamin D for individuals under 71 years of age (Ross et al. 2011). Grant (2011) advocates that 2000-7000 IU/day vitamin D are needed to increase circulating levels of vitamin D to ~100 nmol/L. However, the Dietary Reference Intake guidelines indicate that that tolerable upper intake level (UL) for vitamin D is 4000 IU/day for males and females over the age of nine. Conversely, a recent risk assessment indicates that vitamin D exposure is safe at levels >10 000 IU/day and that 10 000 IU/day is an appropriate UL for vitamin D (Hathcock et al. 2007). Thus demonstrating controversy regarding the risk of vitamin D toxicity.

Altogether, Grant (2011) presents a convincing and exciting argument for increasing one’s vitamin D intake and, ultimately, circulating vitamin D levels. Despite literature demonstrating inverse relationships between vitamin D status and disease risk alongside a calculated increase in life expectancy of ~ 2 years when serum vitamin D levels are increased to ≥ 100 nmol/L, caution is still necessary because of divisive opinions regarding vitamin D’s UL and the risk of toxicity. Future research investigating mechanisms by which vitamin D modulates processes that reduce the risk of disease is warranted. Until then, any plans to dramatically increase your daily vitamin D intake should be discussed with your doctor.

For further information on regulatory and scientific issues please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for business growth you can trust. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com

References

Grant WB. An estimate of the global reduction in mortality rates through doubling vitamin D levels. Eur J Clin Nutr. 2011. [Epub ahead of print].
Hathcock JN, Shao AS, Reinhold V. Risk assessment for vitamin D. Am J Clin Nutr. 2007; 85:6-18.
Ross AC, Taylor CL, Yaktine AL, Del HB. and Del Valle HB. Dietary Reference Intakes: Calcium Vitamin D. Institute of Medicine of the National Academies. The National Academies Press. Washington, D.C. 2011.

SPECIAL ALERT: Health Canada’s Current Position on Oil of Oregano

Prepared by:
Christopher P.F. Marinangeli PhD, RD

Oil of oregano, derived from species of Origanum spp., is a popular natural health product that is acclaimed for its ability to reduce upper respiratory tract infections. Recently, Health Canada began issuing Section 16 notices for Oil of Oregano products currently for sale in Canada. Health Canada’s concern refers to levels of carvacrol, an alcohol that is naturally present in oil of oregano. Given that levels of carvacrol can vary substantially within and between species of Origanum and few human clinical trials have investigated the safety of carvacrol within humans, Health Canada has indicated that oil of oregano products that provide ≥ 0.22 micrograms carvacrol /kg body weight per day cannot be considered non-medicinal ingredients and will remain adulterated unless the appropriate safety data can be provided. Health Canada’s 0.22 microgram cut-off is derived from The Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) where the Maximum Survey-Derived Dietary Intake (MSDRI) of carvacrol for the European Union was determined to be 0.23 ug/kg bw/day for a 70 kg human.

It should be noted that Health Canada’s concerns over oil of oregano are directed at levels of carvacrol and not oil of oregano. Thus, oil of oregano products that provide minimum levels of carvacrol should be exempt from Section 16 notices distributed by Health Canada.

Currently, oil of oregano is a valuable product line within Canada’s Natural Health Product industry. As Dicentra Inc. continues to monitor Health Canada’s position on carvacrol, we invite manufacturers, suppliers and retailers to contact us to discuss solutions for navigating through Canada’s regulations for oil of oregano-derived carvacrol and provide solutions that minimize loss of market share.

We can be reached at 1-866-647-3279 or at dicentra.com

Drugs in Supplements? – New Site Keeps Industry Informed on Tainted Products Sold as Supplements

Drugs in Supplements? New Site Keeps Industry Informed on Tainted Products Sold as Supplements

Lydia Hunziker, BComm
Manager of Communications and Client Services, Dicentra

When consumers purchase a natural health product, not only do they expect the content to match the label, they expect no pharmaceutical drugs to be included. After a series of FDA investigations revealed substances such as sibutramine (Meridia) were found in some weight loss products and PDE inhibitors (Viagra) in sexual enhancement products, both the FDA and the natural product industry agreed new strategies had to be developed. In this effort, the American Herbal Products Association (AHPA) has taken the lead by launching a website called KeepSupplementsClean.org. The website is designed to keep the dietary supplement industry informed on issues related to illegal tainted products being sold as supplements.

Since 2008 the FDA has identified almost 300 dietary supplement products that contained undeclared prescription drugs and other chemicals. Late last year the FDA issued a letter to industry which sparked a series of meetings with various trade associations, including the AHPA. These discussions revealed a shared interest to develop strategies and resources to stop the selling of illegal products masquerading as supplements.

The KeepSupplementsClean.org website highlights the categories that experienced the most adulteration i.e. weight loss, sexual enhancement, and body building, and provides links to communications from the FDA on each of them. Although the website is focused on being a resource for industry, the AHPA hopes that interested consumers may also find the information valuable. To truly ‘keep supplements clean’ a strong collaboration between the FDA, the industry and consumers will be necessary moving forward.

For any questions on regulatory issues in Canada or the US please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for business growth you can trust. Our international expertise is specialized in the areas of natural health products, dietary supplements, OTCs, foods and cosmetics.

We can be reached at 1-866-647-3279 or at dicentra.com

References :

1. www.keepsupplementsclean.org (Visited August 26, 2011)
2. www.naturalproductsinsider.com (Visited August 26, 2011)

Dicentra Bi-Weekly Regulatory Updates

Health Canada

Natural Health Products Directorate – NHPD

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php

NHPD Releases its Status of Applications Quarterly Report: Quarter 1

  • NHYPD has received 62201 PLA from Jan 1, 2004 to June 30, 2011.
    • 85% PLAs completed
    • Issuance of 29011 product licences, representing 39973 products.
  • Of the 10885 PLAs and amendments received before August 5th, 2010 (pre-UPLAR PLAs), 3561 have been completed or are in the process of being completed.
    • NHPD committed to completing the remaining 7324 applications before NHP-UPLAR is repealed in February 2013.
  • Of the 9697 applications and amendments received on and after August 5th, 2010 (post-UPLAR PLAs), 48% fully meet NHPD’s pre-cleared information (60 day target) and 52% require full assessment (180 days review target)
  • Performance Targets:
    • 30 day initial assessment: 96%
    • 60 day pre-cleared information: 98%
    • 180 day full assessment: 97%
  • NHPD received 1826 Site Licence Applications from Jan 1, 2004 to June 30, 2011
    • 1770 SLAs have been completed
    • Issuance of 1198 site licences
    • 2174 Site Licence Renewals have been received
    • 96% of all Site Licence renewals have been completed.
    • Quarter 1: 45 SLAs received, 99 Site Licence Renewals received
      • 63 SLAs completed
      • 114 Site Licence Renewals completed.
  • NHPD received 347 Clinical Trial Applications (CTAs) between Jan 1, 2004 and June 30, 2011
    • 324 CTAs have been completed
    • Issuance of 277 notices of authorization
    • Remaining were refused or withdrawn by the applicant.
    • Quarter 1: NHPD received 15 CTAs and 9 CTA Amendmens
    • 15 CTAs completed
    • 9 CTA amendments completed.

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/report-rapport/qar_tri_1-12-eng.pdf

EFSA

http://www.efsa.europa.eu/

EFSA launches public consultation on draft guidance for the risk assessment of food and feed derived from GM animals and related animal health and welfare aspects

August 10, 2011

Guidance document outlines specific data requirements and the methodology to be followed for risk assessment should applications for food and feed derived from genetically modified animals be submitted for market authorization in the European Union.

http://www.efsa.europa.eu/en/press/news/110810.htm

Public consultation on a draft guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health.

  • Deadline: August 31, 2011

http://www.efsa.europa.eu/en/consultations/call/nda110426a.htm

Public consultation on a draft guidance on the scientific requirements for health claims related to bone, joints and oral health

  • Deadline: August 31, 2011

http://www.efsa.europa.eu/en/consultations/call/nda110426b.htm

Public consultation on a draft guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations

  • Deadline: August 31, 2011

http://www.efsa.europa.eu/en/consultations/call/nda110426.htm

Medicines and Healthcare products Regulatory Agency

http://www.mhra.gov.uk/index.htm

Press release: Public warning against buying dangerous herbal slimming aids online

  • Several products available to buy from overseas websites have received international safety warnings and alerts from health agencies in Sweden, Canada, Australia, Hong Kong and the US. Products including ‘Instant Slim’, ‘Acai Berry ABC’ and ‘Sport Burner’ have been found to contain the prescription-only substance sibutramine which has been withdrawn across Europe due to increased risk of heart attacks and strokes following use.

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON126051

EAS

http://www.eas.eu/

Shift in practices for marketing food products with health benefits imminent in EU

  • 2010 will see advertising messages across the functional food market moving in a new direction as the European Commission begins to finalize its draft article 13.1 “Union List” of permitted health claims.
  • Once the article 13.1 transition period expires, food companies will face the challenge of having to develop alternative ways of marketing and advertising to communicate health and other benefits of products.

http://www.eas.eu/News_Item/748

American Herbal Products Association

http://www.ahpa.org/

AHPA Clarifies Its Position on the Science Linking DMAA to Geranium Oil; New Research on DMAA in Geranium Reported

  • The trade requirement, which becomes effective on January 13, 2012, requires that AHPA members do not label 1,3-dimethylamylamine, whether identified by this name or any synonym, as geranium oil or as any part of the geranium plant, whether by the common name of geranium or by the botanical name of any plant known as geranium.
  • In an August 8 statement to announce this policy, AHPA referenced a review of one published study that reported DMAA as a naturally occurring constituent of the geranium species, Pelargonium spp. In this announcement, AHPA inadvertently stated that there are no known-published reports indicating that DMAA is a natural product. This was a misstatement since the announcement noted the study, by Ping et al. (Ping Z, Jun Q, Qing L. A study on the chemical constituents of geranium oil. Journal of Guizhou Institute of Technology 1996;25:82-85), which identified the presence of DMAA in geranium.
  • In the interim, AHPA has been informed by an analytical chemist and an AHPA member that they have initiated new research on the chemistry of geranium. Both have reported that their preliminary results indicate the presence of DMAA, and some effort to validate these results is now planned.

AHPA Launches New Website to Inform Industry about Tainted Products Being Sold as Supplements

  • The American Herbal Products Association (AHPA) has launched a new website called KeepSupplementsClean.org, which is designed to keep the dietary supplement industry informed on issues related to illegal tainted products being sold as dietary supplements.

Natural products Insider

http://www.naturalproductsinsider.com/

EHPM: EFSA Should Expand 13.1 Claims Evidence

  • The European Federation of Associations of Health Product Manufacturers say EFSA should go beyond intervention trials when it determines article 13.1 (General function) claims evaluations.
  • Essential that the totality of data is weighted by assessing the strength and consistency of data.
    • Example: EFSA’s approach cannot confirm that a diet rich in fruits and vegetables promotes heart health.

http://www.naturalproductsinsider.com/news/2011/08/ehpm-efsa-should-expand-13-1-claims-evidence.aspx

Nutraingredients

http://www.nutraingredients.com/

China set to slash approved health claims by a third

  • In 2009, China passed the Food Safety Law which included 27 approved health claims.
  • Claims for sleep and fatigue were not supported by human clinical data and could be revoked.

http://www.nutraingredients.com/Regulation/China-set-to-slash-approved-health-claims-by-a-third

British botanical group welcomes “new era” in herbal products in Europe

  • The British Herbal Medicine Association supports the Traditional Herbal Medicinal Products Directive.
  • Will increase the credibility of the sector by improving product quality, standardising claims and boosting public confidence in herbal products.

http://www.nutraingredients.com/Regulation/British-botanical-group-welcomes-new-era-in-herbal-products-in-Europe

Novel Food Approval: EU Approves Rooster Comb Extract (RCE)

Novel Food Approval: EU Approves Rooster Comb Extract (RCE)

Rupika Malhotra, MSc
Regulatory Associate, Dicentra

In recent years, several novel and arguably eccentric food ingredients have made their way into the food and natural health product markets worldwide for their various health promoting benefits. One such product on the fore front of entering the European market is rooster comb extract (RCE).

Traditionally used in Spanish dishes, RCE is being added to food consumed on a daily basis throughout Europe, by Biobercia, a Spanish company. Milks, yogurts, dairy based beverages and fromage frais enriched with RCE will be marketed to adults: mainly athletes, the elderly and menopausal women with health claims of maintenance of joint health. Proposed to aid in joint lubrication and cushioning through elevated levels of sodium hyaluronates (SH) at up to 60% to 80%, dairy products enriched with RCE are close to novel food approval by the Advisory Committee on Novel Foods and Processes (ACNFP). Extracted from the large fleshy red skin on top of the cockerl’s head, RCE is also shown to contain glycosaminoglycan (approx. 20%) and partially hydrolyzed proteins (approx 20%).

Comments on the draft opinions have recently been taken into consideration. In the final stages of approval of the ingredient into the food and supplement market all safety concerns have been dismissed. As such, the ACNFP stresses that the approval as a novel food is based solely on the safety of the use of such an ingredient, and not yet the possible health claims associated with it.

For assistance in food regulatory issues or other regulatory matters, please contact our experts at Dicentra.

Dicentra provides regulatory and scientific solutions for business growth you can trust. Our international expertise is specialized in the areas of natural health products, dietary supplements, OTCs, foods and cosmetics. We can be reached at 1-866-647-3279 or at dicentra.com

  1. Hills, S. Rooster comb extract close to novel food approval – Food Navigator, (August 03, 2011), http://www.foodnavigator.com/Legislation/Rooster-comb-extract-close-to-novel-food-approval , (Visited August 16, 2011)
  2. The Advisory Committee on Novel Foods and Processes. Rooster Comb Extract, (February, 2011), http://acnfp.food.gov.uk/assess/fullapplics/roostercombsextract/ , (Visited August 16, 2011)

Health Canada Looking to Regulate Vitamin-Enhanced Products

Health Canada Looking to Regulate Vitamin-Enhanced Products

Arwen Brooks
Research and Regulatory Assistant, Dicentra Inc.

Despite Health Canada’s widespread regulation of the Natural Health Product industry, there are products being sold that have been overlooked in the initial definition of what is and is not a natural health product (NHP).

Various products that fall under the definition of a food have been under scrutiny for fortifying snacks and drinks with levels of vitamins and minerals that are not permitted by the Food and Drug Regulations. The addition of these ingredients would make such products NHPs, and amendments to the existing regulations have yet to be addressed, even though awareness of the issue has been known for over two years.

The chief of Health Canada’s nutrition evaluation division, Nora Lee, released the following statement of this oversight: “This legal loophole continues to have a significant potential to impact on the ability to administer the provisions of the Food and Drug Regulations with respect to foods.”

Health Canada’s food regulations control the amount of vitamins and minerals that can be added to drinks and foods, but companies are using this oversight by classifying vitamin-fortified products as NHPs. The current food regulations have imposed a limit on the amount of nutrients that can be added to foods, to ensure the safety and integrity of the foods, and to prevent adverse effects from the overconsumption of certain nutrients.

The 2004 Natural Health Product Directorate regulations were established to cover herbal products and traditional medicines, but also oversee the addition of vitamins or minerals to beverages and candy-like products with the intention of providing a beneficial effect. This issue will require the review of what are commonly considered “foods”, in order to adequately monitor the production of “food-like” NHPs.

There are currently around 700 different “food-like” natural health products that are routinely sold in grocery stores in Canada. Due to this loop-hole, they are not required to provide any nutritional labelling information that is mandatory for food products, as they are no longer regulated as “foods”.

In a statement to Postmedia News on Wednesday, Health Canada said it “will continue to explore how best to manage these products in order to protect the health and safety of Canadians and ensure that Canadians can continue to make informed choices about the products that they buy.”

“In the interim, Health Canada continues to review its approach to regulating natural health products in food formats.”

For assistance in this matter or other regulatory issues, please contact our experts at Dicentra.

Dicentra is a leading international regulatory and scientific consulting firm with specialized expertise in the areas of natural health products, dietary supplements, OTCs, foods and cosmetics. We can be reached at 1-866-NHP-EASY or info@dicentra.ca

References

The Montreal Gazette
http://www.montrealgazette.com/health/Vitamin+enhanced+products+skirting+Health+Canada+regulations/5133784/story.html

Non-Medicinal Ingredient Labeling for Nonprescription Drug Products

Health Canada Update:

Non-Medicinal Ingredient Labeling for Nonprescription Drug Products

Clara di Tella, BSc, Pharm QA
Regulatory Affairs Specialist

Health Canada has released a notice to inform drug manufacturers/sponsors of its expectations for non-medicinal ingredient labeling for nonprescription drug products. The amendment to the Food and Drug Regulations published in the Canada Gazette II on May 26, 2010, will come into effect on May 13, 2012. The amendment requires that non-medicinal ingredients be listed on the outer label of nonprescription drug products for human use.

This amendment affects drugs that have already received market authorization and new applications. This revision does not affect prescription drugs, non-prescription drugs that are only administered by a health care practitioner, low-level disinfectants or veterinary-use drugs.

For drug products that have already received market authorization, Health Canada is requesting that manufacturers/sponsors submit an attestation letter indicating the date on which their products have been or will be in compliance with the non-medicinal labeling requirements. A template of the attestation can be found on the Health Canada website and it should be submitted as part of the response to the Annual Drug Notification request. New applications submitted should be in compliance with the regulations as they will be assessed based upon the new requirements.

The regulations outline that the outer label of the drug product must have a list of the non-medicinal ingredients contained in the product. If the outer label is too small and cannot present the non-medicinal ingredient list, the list must be on a card or tag and attached to the package. The list must be preceded by a heading which clearly distinguishes the non-medicinal ingredients from the medicinal ingredients, for example “non-medicinal ingredients” or “inactive ingredients”. The ingredients must be listed in alphabetical order or in descending order of its proportion in the drug.

For assistance in this matter or other regulatory issues, please contact our experts at Dicentra.

Dicentra is a leading international scientific and regulatory consulting firm with specialized expertise in the areas of natural health products, dietary supplements, OTCs, foods and cosmetics. We can be reached at 1-866-647-3279 or at dicentra.com

Citicoline: The New Co-Enzyme Q10?

By Candice Cryne, MSc.
July 15, 2011

As medical science and technology advances, so does the average life expectancy. However, this increase in life expectancy comes with a greater risk of developing a plethora of age-related diseases including, but not limited to cardiovascular disease, stroke, diabetes, osteoporosis, cancer, arthritis, and dementia.

The number of individuals suffering from dementia is projected to double in Canada over the next 25 years from half a million to 1.1 million (Alzheimer’s Society, 2010).

The onset of dementia (Alzheimer ’s disease is the most common type of dementia) is associated with a variety of ailments including Parkinson’s disease, Multiple Sclerosis, Lewy Body Disease, Huntington’s Disease, viral or bacterial infections and tumors etc.

Furthermore, experiencing a stroke has been shown to considerably increase the likelihood of dementia in the elderly (Ivan et al., 2004). Post-stroke vascular dementia (VaD) affects 30% of survivors, and the incidence of new-onset dementia increases from 7% 1 year after stroke to 48% after 25 years (Leys et al., 2005).

There has been a substantial amount of prescription medication and natural products purported to treat or reduce the risk of dementia. Currently citicoline is sold around the world as a natural health product or dietary supplement. Within Health Canada’s Natural Health Product Ingredients Database, this ingredient is unrestricted and is classified as a medicinal ingredient.

Physiologically, citicoline is a naturally occurring endogenous nucleoside that functions as an intermediate in 3 major metabolic pathways (Sabin and Roman, 2010). “Citicolin formation is the rate limiting step in the synthesis of phosphatidylcholine (lecithin) in neuronal membranes and microsomal phospholipids; citicoline provides choline for acetylcholine synthesis and could limit choline availability for membrane synthesis; and oxidation to betaine, a methyl donor (Sabin and Roman, 2010)”. Furthermore, citicoline has been found to be readily absorbed in the gut, cross the blood-brain barrier (Conant et al., 2004) and demonstrate a bioavailabllity of 100% after oral administration (Davalos et al., 2002).

In the 1990’s, the clinical development of citicoline for the treatment of acute ischemic stroke was initiated in the United States (Davalos et al., 2002). Phase II-III clinical trials were conducted to evaluate the effects of 500, 1000 and 2000 mg/d of citicoline compared to placebo. The 500 and 2000 mg dose resulted in significant improvement of neurological (National Institute of Health Stroke Scale [NIHSS]), functional (Barthel Index [BI]), and global (modified Rankin Scale [mRS]) outcomes compared to placebo over 12 weeks (Clarke et al., 1997, Clarke et al., 1999). However, the last trial conducted to confirm the effects of 2000 mg/d of citicoline on neurological and functional outcomes of patients with moderate to severe ischemic stroke did not demonstrate any significant improvement when evaluated using the NIHSS scale, which was the primary endpoint for assessing neurological function (Clarke et al., 2001). Since there was discrepancy between the studies, Davalos et al., 2002 performed a meta-analysis of individual patient data to test whether treatment with oral citicoline for 6 weeks improves overall recovery at 3 months for patients with acute ischemic stroke. The results found that recovery at 3 months was 25.2% in citicoline-treated patients and 20.2% in placebo treated patients (P = 0.0034), with the highest favourable response in the 2000 mg citicoline group (P = 0.045). Furthermore, citicoline significantly increased the probability to recover activities of daily living by 29% and probability to recover function capacity (mRS) by 42%. In a recent review paper from Davalos and Secades, 2011, they described two major clinical trials that are underway to further evaluate the efficacy of citicoline. The Citicoline Brain Injury Treatment trial (COBRIT), conducted in the United States, is a randomized, double-blind, placebo-controlled, multicenter trial designed to analyze the effects of 90 days of citicoline (1g twice daily) or placebo supplementation on functional outcome in patients with complicated mild, moderate, or severe traumatic brain injury. The sample size is approximately 1500 patients, and the results are expected late 2011. In Europe, the International Citicoline Trial on Acute Stroke (ICTUS) trial is underway and actively recruiting patients.

ICTUS is a multicenter, randomized (under minimization), double-blind, placebo-controlled trial whichwill follow a sequential analysis (triangular model), with 2600 patients. This design has 80% power to establish a treatment effect of 1.26 (common odds ratio). The primary end point will consist of a global score test combining 3 measures of success evaluated 12 weeks after treatment on the basis of intention-to-treat criteria: neurological (NIHSS score ≥1), disability (modified Rankin scale score ≤1), and activities of daily life (Barthel Index score ≥95), all averaged using a global test (Davalos and Secades, 2011).

In addition to neurologicl benefits in stroke victims, citicoline has shown potential in the field of ophthalmology. Citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). An efficacy study is currently underway to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, pattern ERG and visual evoked potentials are to be measured (Clinicaltrails.gov #NCT01338389).

In the next coming years, it will be interesting to see if the efficacy of this naturally occurring endogenous nucleoside can be proven to help prevent stroke related dementia, as the safety and tolerance is excellent with very few side effects (Davalos and Secades, 2011).

References:

Alzheimer’s Society. Alzheimer’s Disease Statistics. Key Facts about Alzheimer’s Disease and Related Dementia. http://www.alzheimer.ca/english/disease/stats-intro.htm Accessed July 15, 2011

Clark WM, Warach SJ, Pettigrew LC, Gammans RE, Sabounjian LA. A randomized dose-response trial of citicoline in acute ischemic stroke patients. Citicoline Stroke Study Group. Neurology. 1997;49:671– 678.

Clark WM, Williams BJ, Selzer KA, Zweifler RM, Sabounjian LA, Gammans RE. A randomized efficacy trial of citicoline in patients with acute ischemic stroke. Stroke. 1999;30:2592–2597.

Clark WM, Wechsler LR, Sabounjian LA, Schwiderski UE, Citicoline Stroke Study Group. A phase III randomized efficacy trial of 2000 mg citicoline in acute ischemic stroke patients. Neurology 2001;57: 1595–1602.

Conant R, Schauss AG. Therapeutic applications of citicoline for stroke and cognitive dysfunction in the elderly: a review of the literature. Altern Med Rev. 2004;9:17–31.

Davalos A, Castillo J, Alvarez-Sabín J, Secades JJ, Mercadal J, Lo´pez S, Cobo E, Warach S, Sherman D, Clark WM, Lozano R. Oral citicoline in acute ischemic stroke: an individual patient data pooling analysis of clinical trials. Stroke. 2002;33:2850 –2857.

Dávalos A, Secades J. Citicoline preclinical and clinical update 2009-2010.

Stroke. 2011 Jan;42(1 Suppl):S36-9. Epub 2010 Dec 16. Review.

Ivan CS, Seshadri S, Beiser A, Au R, Kase CS, Kelly-Hayes M, Wolf PA. Dementia after stroke: the Framingham Study. Stroke. 2004;35: 1264–1268.

Leys D, He´non H, Mackowiak-Cordoliani MA, Pasquier F. Poststroke dementia. Lancet Neurol. 2005;4:752–759.

Warach S, Pettigrew LC, Dashe JF, Pullicino P, Lefkowitz DM, Sabounjian L, Harnett K, Schwiderski U, Gammans R. Effect of citicoline on ischemic lesions as measured by diffusion-weighted magnetic resonance imaging. Citicoline 010 Investigators. Ann Neurol. 2000;48:713–722.

Dicentra makes contribition to the Direct Selling Education Foundation of Canada

 

Dicentra has recently made a $100.00 contribution to the Direct Selling Education Foundation of Canada (DSEF). The DSEF supports research and education programs that are expanding knowledge and understanding of the fundamental principles of direct selling.

The DSEF commissions academic research and sponsors campus programs in the fields of marketing and entrepreneurship. These efforts provide insights into the latest direct selling trends, offer solutions for better business, and help prepare the next generation of industry leaders.

We can be reached at 1-866-647-3279 or at dicentra.com

E-IRNs & Traditional Claims Submissions

By:Ashleigh Hampton, MSc
June 30, 2011

In August of 2010, Health Canada issued a notice to natural health product license applicants to provide clarification on the requirements for traditional claim submissions. Most recently, the NHPD has been re-issuing Evidence Information Request Notices (E-IRNs) to give applicants a chance to review their requirements and take action to ensure their traditional applications are up to par. When an application is classified as traditional, there are certain criteria the NHPD requires the product to meet in order to be considered a traditional formulation.

Each ingredient present in a traditional formulation must have supporting evidence demonstrating its history of traditional use. This evidence must be published in an authoritative, primary, traditional reference which outlines the traditional route of administration, dosage and method of preparation used in the specific traditional healing paradigm (e.g. Herbal Medicine, Traditional Chinese Medicine (TCM), Ayurveda). Furthermore, provided references must support the traditional use of the ingredient in the same traditional healing paradigm, meaning that if you have a claim such as “traditionally used in Herbal Medicine to help relieve nervousness”, evidence from the TCM or Ayurvedic paradigms will not be sufficient to demonstrate the traditional use of any of the ingredients in the formulation. In this case, all provided references must support the use of each medicinal ingredient in the Herbal Medicine paradigm.

Additionally, it is imperative that the method of preparation of the ingredients match the traditional evidence for every ingredient in the formulation. For example, you have an ingredient which has been prepared by supercritical CO2 extraction, a non-traditional method of preparation, the NHPD will consider this to be non-traditionally prepared ingredient. In this case, a non-traditional application should be filed. Again, it is important that the method of preparation of the ingredient match the method of preparation indicated in the authoritative traditional references for the specified traditional healing paradigm.

It is important to note that traditional evidence does not typically support the safe use of traditional ingredients in certain high risk subpopulations, such as pregnant women, breastfeeding women or children. If you wish to target your product to one of the higher risk sub-populations, clinical evidence would be required to support the safe use of each ingredient in these sub-populations.

TCM Claims

Applications making claims based on the theory of Traditional Chinese Medicine have additional evidence requirements. The NHPD considers all herbs listed in the TCM references to be prepared by water decoction. As such, it is required that ingredients in a traditional TCM product be water decocted, unless otherwise stated in the authoritative traditional evidence.

Furthermore, acceptable TCM formulas should stem from a TCM base formula. The applicant is required to submit a detailed combination rationale outlining any and all deviations from the base formula, including herb substitutions and dosage revisions.

Without a TCM base formula, the NHPD requires a highly detailed combination rationale outlining the actions of each medicinal ingredient based on the theory of TCM. The combination rationale must address the roles of the herbs (i.e. the king, minister, assistant and messenger) and outline how each of these herbs contributes to the overall efficacy of the formulation. Please note, compilation of the combination rationale for these applications requires sufficient expertise and understanding of the theory of TCM.

In summary, if you are using ingredient with methods of preparations which may not be considered traditional or are not present in the authoritative traditional references, it is best to file a non-traditional application. Dicentra offers a full range of scientific support, including formula reviews to help you determine whether your formula meets the criteria for a traditional claim submission.

For additional information on traditional claims submission please refer to the following NHPD Guidance Document:

Nutra-ingredients – Regulatory Updates: Cholesterol Labelling – June 27, 2011

http://www.nutraingredients.com/

June 16, 2011

EU ‘agreement’ may outlaw cholesterol labelling

Optional cholesterol labelling of food products may soon be banned in the European Union if a draft regulation on food information to consumers passes in its existing form.

The European Natural Soyfoods Manufacturers Association (ENSA) says an ‘informal political agreement’ between the European Commission, European Parliament and European Council was reached yesterday to prohibit the labelling practice.

“ENSA believes that this move is an inadequate and overly restrictive measure which goes directly against the objective of the regulation to enable consumers to make informed food choices,” the Brussels-based group said.

“The move will unduly inhibit producers to provide factual, objective information on the cholesterol content of products and will deprive consumers of the possibility to obtain such information on food packaging.”

“ENSA strongly regrets the disappointing outcome of the negotiations on this issue and calls for an urgent review of the informal agreement to safeguard the right to provide voluntary information on cholesterol content in the nutrition declaration.”

Cholesterol intake

ENSA noted that the European Food Safety Authority (EFSA) had acknowledged that dietary cholesterol intake increases blood cholesterol in 2010, which was a risk factor in the development of heart diseases.

“The voluntary provision of factual, objective information on the dietary cholesterol content of foodstuffs is therefore useful and relevant for consumers.”

http://www.nutraingredients.com/Regulation/EU-agreement-may-outlaw-cholesterol-labelling

June 27, 2011

ANH: Herbal Medicinal Products Directive is “a protectionist tool”

The Alliance for Natural Health International has slammed the European Commission’s Traditional Herbal Medicinal Products Directive as “a protectionist tool.”

In an open letter to European commissioner John Dalli, Robert Verkerk, the alliance’s founder and scientific director wrote: “It seems that the criticism you now face in some quarters is down to the creation by the EU of what is effectively a protectionist tool; one which favours certain products of the European phytopharmaceutical system and discriminates against those of non-European traditional systems of medicine.”

Verkerk’s letter follows a forum in the European Parliament on 21 June to consider the challenges posed by the Traditional Herbal Medicinal Products Directive (THMPD Directive 2004/24/EC) to traditional systems of medicine; particularly those of non-European origin.

Herbal practitioner

The new legislation requires that traditional herbal medicinal products, many of which have been used in Europe for decades, must be licensed or prescribed by a registered herbal practitioner in order to comply with a directive passed in 2004 and implement on May 1 2004.

In the UK, for example, over-the-counter herbal medicine products require either a Traditional Herbal Medicines Registration (THR) or a full marketing authorisation. To be eligible for a licence, products must have been on the market for 30 years, including 15 within the EU.

So far, only about 100 herbal products have been registered under the THR scheme, which is run by the Medicines and Healthcare Products Regulatory Agency (MHRA). This could mean that thousands of products may eventually be banned.

But in a letter to Giles Chichester MEP on 13 April 2011, Dalli said that there were no additional barriers to the registration of Ayurvedic and traditional Chinese medicine (TCM) compared with products from other European traditions.

Verkerk responded by writing: “By contrast not a single product authentic to the Ayurvedic, Unani, TCM, Tibetan, Thai, southern African or Amazonian – or, indeed any other non European – system has yet been registered.”

The open letter goes on to list four barriers allegedly preventing the uptake of registrations among the non-European traditions. Those are claimed to be: Eligibility limitations, technical limitations, excessive cost, and lack of incentive.

The eligibility barrier refers to traditional use requirement specifying at least 15 years useage within the EU. “This locks out many products which that may have been used for decades or even centuries, or even millennia outside the EU,” wrote Verkerk.

Technical limitations

Technical limitations refer to the pharmaceutical and stability standards set out in the European Medicines Agency (EMA) guidelines. These are more straightforward for single-herb products or limited combinations than for most authentic traditional herbal medicinal products which are often whole herb or aqueous extractions.

Registration fees varying from €2,000 to €50,000 per product are “…unquestionably out of reach of the small-to-medium sized enterprises (SME) supplying products associated with non-European traditional systems,” wrote Verkerk.

Finally, a lack of financial incentive to register non-European medicines is said to be a powerful disincentive to take up registrations.

Verkerk ends his open letter with a plea for Dalli to comment on his concerns and for the Commission to consider the feasibility of a new regulatory framework more appropriate for holistic systems of medicine.

No one from the Commission was available to respond to Verkerk’s criticisms. But an EC spokeswoman promised a response by the end of next month.

http://www.nutraingredients.com/Regulation/ANH-Herbal-Medicinal-Products-Directive-is-a-protectionist-tool