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NHPD Provides Update on Transition of Assessment of NHP Clinical Trial Applications for Primary Indications Inappropriate for Self-Care

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The NHPD has Transitioned the Assessment of NHP Clinical Trial Applications (for primary indications inappropriate for self-care)  and Adverse Reaction Reporting to the TPD.

Health Canada informed the industry through two notices, sent August 2012 and October 2012 of the two phases of a pilot program to streamline the review of NHP Clinical Trial Applications. The first phase of this program involved the transitioning of the assessment of Clinical Trial Applications for certain claims – i.e. those that are inappropriate for self-care, to the Therapeutics Products Directorate (TPD) or Biologics and Genetic Therapies Directorate (BGTD), as appropriate for review1. Amendments to NHP Clinical Trial Applications that are not appropriate for self care, will also be transitioned to the TPD. The second phase of this pilot program involved transitioning all adverse reaction reporting from NHP Clinical Trials to the TPD or BGTD, as appropriate. As of November 27, 2012, the NHPD officially started the transition to move NHP adverse reaction report files to the TPD and/or BGTD. It is important to note that all adverse reaction reporting for Clinical Trials of NHPs has been outsourced to the TPD and BGTD, not just for trials for claims that are inappropriate for self-care.

To help ease the transition the NHPD informed affected stakeholders (i.e. those identified as a contact on a NHP Clinical Trial Application) through notices that were sent out on August 1, October 5 and November 27, 2012 to expect a change in the reporting structure of clinical trials2. The NHPD has indicated that although assessment of NHP Clinical Trial Applications and Amendments to applications for products with indications inappropriate for self care is being transitioned to TPD a similar assessment approach will be maintained, and the same NHPD application forms are to be used. The only major change that you should be aware of is that there has been a significant reduction in the time provided by the NHPD to respond to Information Request Notices (IRNs) from 30 days to 2 days.

Currently, the NHPD is working to develop tools to ensure the transition of information is as seamless as possible, while allowing assessment officers at the TPD or BGTD access to the NHP Clinical Trial Application files. dicentra will be sure to inform you as soon as any new information on the NHP Clinical Trial Application transition is provided by Health Canada.

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 info@dicentra.com

 

References:

1. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_12-03-12-eng.php

2. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/clini/nhp-psn-eng.php

New Study Finds Modest Reduction In Cancer In Middle-Aged And Older Heathy Men Taking Multivitamins

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Council for Responsible Nutrition
www.crnusa.org

FOR IMMEDIATE RELEASE

Washington, D.C., October 17, 2012—A new study published today in JAMA (Journal of the American Medical Association) found “daily multivitamin supplementation modestly but significantly reduced the risk of total cancer” in a large population of healthy male physicians. 

The multivitamin and cancer arm of the Physicians’ Health Study (PHS) II, the only large-scale, randomized, double-blind, placebo-controlled trial (RCT) to study the long-term effects of a multivitamin in chronic disease, was conducted by researchers at Brigham and Women’s Hospital and Harvard Medical School and will be presented today by lead corresponding author J. Michael Gaziano, M.D., M.P.H., at the annual American Association for Cancer Research Frontiers in Cancer Prevention Research meeting.  PHS II studied nearly 15,000 male U.S. physicians aged 50 years and older for over a decade.

According to the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, the well-designed study provides encouraging news, particularly for healthy men looking to remain healthy.  “This study reinforces the value of long-term consistent use of a daily multivitamin as a convenient and affordable insurance policy for good health,” said Duffy MacKay, N.D., CRN’s vice president, scientific and regulatory affairs.  “Whether or not this study can be generalized to the total population is not answered by this study; however, there are other well-researched benefits for the multivitamin in the general population.”

For example, women of child-bearing age are regularly advised to take a multivitamin with 400 mcg of folic acid to help prevent certain birth defects such as spina bifida.  Additionally, many Americans, despite being overfed, are not getting the essential nutrients necessary for good health, and a daily multivitamin helps fill those nutrition gaps.

In fact, in CRN’s most recent annual consumer survey on dietary supplements, when asked why they take dietary supplements, vitamin/mineral users ranked  “to help reduce the risk of serious illness” eighth on the list, with “overall health and wellness benefits” and “to fill in nutrient gaps in their diet” cited as the number one and two reasons, respectively.

Not only did this study provide good news for the supplement industry and its consumers, but it provided another reminder that science should be viewed in the context of the full body of scientific literature. For those who have previously tried to shut the door on the benefits of taking a multivitamin, this study, says Dr. MacKay, “pushes the door and the windows wide open to the benefits and safety of multivitamins.”

CRN urges the importance of keeping in mind that cancer is a multifactorial disease, and that even with the positive scientific news demonstrated by this study, consumers would be wise to also engage in other common-sense habits. Preventing chronic disease, such as cancer, likely involves the combination of long-term consistent, smart lifestyle choices, including a healthy diet, vitamins and other supplements, regular exercise, routine visits to your physician, and decreasing stress. Says Dr. MacKay, “By all means, take your daily multivitamin, as a supplement to, not a substitute for, other healthy lifestyle choices.” 

Fact Box

  • The multivitamin is the most popular dietary supplement.1
  • 52 % of American adults take multivitamins; 42% of American adults take multivitamins regularly.1
  • 56% of American adult women and 48% of American adult men take multivitamins.1
  • 72% of physicians personally use dietary supplements and the multivitamin is the most popular dietary supplement taken by this population.2

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1Council for Responsible Nutrition. (2012). CRN Consumer Survey on Dietary Supplements. Retrieved October 4, 2012, from http://crnusa.org/CRNPR12-ConsumerSurvey100412.html

2 Dickinson A, Boyon N, Shao A. Physicians and nurses use and recommend dietary supplements: report of a survey. Nutrition Journal 2009, 8:29 doi:10.1186/1475-2891-8-29

Reminder of dicentra’s Free Regulatory Update Webinar – Tomorrow

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June 18, 2012

Free Regulatory Update Webinar: Tuesday, June 19th at 1 PM ET

Dear dicentra Subscriber,

We’re sending you a quick reminder about our free Regulatory Update Webinar, tomorrow, Tuesday, June 19th at 1:00 PM EST.  You are invited to join hundreds of companies already tuning in.

At dicentra we’re committed to keeping our clients and the industry connected and informed.  This quarter’s webinar will include the latest updates and changes in the American and Canadian regulatory environments as they pertain to Natural Health products and Dietary Supplements.

For more details about the presentation, topics and our speakers please continue to read below.

To register for the webinar, please click below:

Register Now


You will receive a confirmation email that schedules the event in your calendar and provides a link to join the meeting.  You can register and join the meeting at any point.  It all takes only a few minutes.

When you join the meeting you can use your computer speakers to listen in on the webinar.

Please visit dicentra.com for weekly regulatory and scientific articles, special alerts and updates.

PRESENTATION TOPICS AND SPEAKERS

Dr. John Harrison, Senior Government Relations Advisor at dicentra, will present on the following Canadian topics:
  • Status of Unprocessed Product Licence Applications (UPLAR)
  • NHP Compliance and Enforcement Policy
  • Status of Applications
  • Products Currently “On Hold”
  • Consultations and Regulatory Initiatives

 

Heather VanBlarcom, General Counsel & Senior Regulatory Specialist for Dietary Supplements at dicentra will present on the following U.S. topics:
  • Dietary Supplements
  • GMPs
  • NDI’s

Don’t miss our next free Regulatory Update Webinar on Tuesday, September 18, 2012 at 1:00 PM EST.

Please visit regulatoryupdates.com to register.

Please visit our website to view our previous webinars and to register for events.  If you have any comments or questions do not hesitate to contact us!

Sincerely,

Peter Wojewnik
Vice President Business Development
dicentra
peter@dicentra.com

The Drafts: Pathways for Licensing Natural Health Products Making Modern Health Claims & Used as Traditional Medicines: What does it mean for your NHPs?

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By:  Ashleigh Hampton, MSc
Manager, Scientific Affairs

On May 23, 2012, the Natural Health Products Directorate (NHPD) released the Draft: Pathway for Licensing Natural Health Products (NHPs) Making Modern Health Claims and the Draft: Pathway for Licensing NHPs Used as Traditional Medicines guidance documents. The following details will highlight the proposed changes and outline how it will impact the evidence needed to obtain your desired claims.

Draft: Pathway for Licensing NHPs Making Modern Health Claims

This guidance document provides insight into the manner in which the NHPD plans to review the non-traditional NHP Product License Applications (PLA). The main objective of this draft guidance document is to outline the risk-based approach proposed to be taken by the NHPD when assessing the evidence provided to support the safe and effective use of your NHPs.

The NHPD has categorized the types of claims applicants may wish to apply for into 3 categories:

  1. High Level of Risk (e.g. products claiming to treat/prevent/cure serious diseases, such as those present on Schedule A of the Food and Drug Act)
  2. Medium Level of Risk (e.g. products claiming to treat/prevent/cure major diseases or health conditions which may not be resolved in a timely manner and which if untreated may worsen or persist, such as hypercholesterolemia)
  3. Low Level of Risk (e.g. products containing ingredients which have good evidence to support their safe use and are making general health maintenance/support claims, treatment/prevention claims for minor diseases or risk reduction claims for major diseases or health conditions).

In summary the evidence required to support the safe use of your product will be dependent on the strength of the claims you wish to make. The NHPD’s Pre-Cleared Information (PCI) stands as the most acceptable evidence available. Second to which are high quality phase III clinical trials and the inclusion of 2 prospective observational studies, with some additional required study criteria. These types of evidence will be sufficient to support all types of health claims.

To support your low and lowest risk health claims the following types of evidence will be acceptable to support the safety and efficacy of your product:

  • Meta-analysis
  • Evidence from a regulatory agency
  • Systematic reviews
  • Phase II clinical trial
  • 2 Retrospective observational study
  • 2 Epidemiological studies
  • Published, peer-reviewed review articles which cite primary clinical evidence
  • Reputable textbooks reporting human clinical data
  • Demonstration of food use (safety only)

With regards to evidence to support the weakest type of health claim, an antioxidant claim, the NHPD is proposing to accept in vivo animal studies using a validated model as stand alone evidence to support the efficacy of your product. This is beneficial as products which are safe, but do not have high quality efficacy evidence will be granted licenses, provided they contain recognized antioxidant ingredients.

In summary, weak evidence will support low risk claims for low risk products and strong evidence will support strong claims even with higher risk products, provided the Draft: Pathway for Licensing NHPs Making Modern Health Claims guidance document is approved.

Another proposed change outlined in this guidance document is the inclusion of traditional claims in a non-traditional PLA. The NHPD is proposing to allow traditional claims on non-traditional products, provided that the traditional claims are not the only claims present on the product label. Additionally, the label must include a non-traditional claim and the traditional claim must include the name of the ingredient and the traditional paradigm in which it has been traditionally used (e.g. Dandelion is traditionally used in Herbal Medicine as a diuretic). It is also important to note that traditional claims from more than one traditional healing paradigm can be present on a single non-traditional PLA – this may alleviate the issues that some applicants have been having when trying to make traditional claims from more than 1 paradigm.

Draft: Pathway for Licensing NHPs Used as Traditional Medicines

The criteria required for a traditional PLA has not changed drastically. The NHPD is proposing to require that all ingredients in a traditional product have evidence to support their use in a single traditional healing paradigm and that the traditional evidence to support the efficacy of the product be supported by evidence demonstrating that each of the herbs have been used in the same traditional healing paradigm for at least 50 consecutive years or 3 generations.

The NHPD is accepting comments on these draft guidance documents until August 21, 2012. Comments can be submitted to nhpd_consultations_dpsn@hc-sc.gc.ca.

For more information on the draft guidance documents, please visit the following links:

Draft: Pathway for Licensing NHPs Making Modern Health Claims – http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/natur/consult_modern-eng.pdf

Draft: Pathway for Licensing NHPs Used as Traditional Medicines -http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/natur/consult_tradit-eng.pdf.

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: Caffeinated Energy Drinks

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 Canada                                                                                 March 23, 2012

Special Alert – Caffeinated Energy Drinks

FOR IMMEDIATE RELEASE

As per previous communication from Health Canada, caffeinated energy drinks will no longer be considered NHPs. They are now deemed as foods and TMAs will have to be filed. TMAL (Temporary Marketing Authorization Letters) will be issued to those that meet the requirements.

The NHPD and Food Directorate sent out the Category Specific Guidance for Temporary Marketing Authorization for Caffeinated Energy Drinks to stakeholders this week. (see link below).

Energy Drinks – Category Guidance Document

The key points in the document are:

  • Definition of “Caffeinated energy drinks” has been clarified
  • Transition of submissions from NHPD to Food Directorate depends on which of the following categories the submission falls in
  • Timelines for transition depend on whether the submission has an NPN, EN, or submission number and are detailed in the document. Please note that all submissions filed after Oct 6, 2011 will be refused and will need to be re-filed as TMAs
  • Details of key dates to submit information with regards to the transition are also marked
  • Permissible Levels of caffeine and vitamins / minerals have been specified
  • Caution statements and guidance related to claims have been specified
  • There will be a requirement to undertake consumption incident reporting as a condition of their TMAs. Reports will need to be submitted to Health Canada annually.

For further information, We can be reached at 1-866-647-3279 or contact us

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

dicentra Special Alert: Proposal to amend the Food and Drug Regulations – Project 1663 – Schedule F Amendment

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 FOR IMMEDIATE RELEASEProposal to amend the Food and Drug Regulations -(addition of pancrelipase, pancreatin and pancreatic enzymes) – Project 1663 – Schedule F Amendment

In November 2011, the NHPD (rather subtly) revised the NHPID entries for pancrelipase, pancreatin and pancreatic enzymes to indicate that they are considering adding these ingredients to Schedule F. As such, they would no longer qualify as NHPs and could only be sold by prescription.  A week ago, Health Canada formally posted a Notice of Intent regarding these enzymes and is inviting stakeholder feedback. This notice, as well as instructions for providing feedback, is available at http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_project_projet_1663-eng.php. Dicentra strongly encourages all product licence applicants who have pancrelipase, pancreatin and/or pancreatic enzymes in their products to read this Notice of Intent and to respond to Health Canada with their comments. The consultation deadline is April 30, 2012.
dicentra provides regulatory and scientific solutions for accelerated business growth.  We specialize in the areas of natural health products, dietary supplements, foods, beverages, cosmetics and OTCs.  We can be reached at 1-866-647-3279 or at dicentra.com