August 28, 2012
A Quick Note….
There have been a number of significant developments on the regulatory front for dietary supplements in the United States lately. For example, dietary supplement claims have come under increased legal scrutiny and we have seen a number of class action suits to demonstrate this. At the NBJ Summit in Dana Point, California a few weeks ago, David Vladeck, the Director of the Federal Trade Commission, stressed the importance of having adequate scientific evidence on hand to substantiate product claims. Vladeck’s advice, “If you are going to make claims, be willing and able to back them up.” Read our article immediately below for a more thorough description of what evidence you are expected to have on hand.
On the GMP front, we continue to see an increase in the number of inspections and the number of Warning Letters issued to supplement manufacturers. According to Daniel Fabricant, head of FDA’s Division of Dietary Supplement Programs, 35% of inspected facilities are classified as ‘official action indicated’ and another 35% as ‘voluntary action indicated.’ Read our article below on FDA inspections to learn and understand more.
As always, we hope you find this newsletter informative. If you have any questions or need any clarification we are always here to help. Enjoy the remainder of this beautiful summer and don’t forget to tune in to our free regulatory update webinars.
VP of Business Development
Health Claim Substantiation
By:Ashleigh Hampton, MSc
Manager, Scientific Affairs
Supporting evidence is required by both the Canadian and American regulatory bodies to substantiate marketed health claims. Health Canada reviews the evidence to substantiate your health claims prior to market access while the US Food and Drug Administration (FDA) requires the supporting evidence to be in the possession of the manufacturer of the marketed product and produced upon request.
Currently, Health Canada requires full-text scientific articles or authoritative traditional evidence to substantiate a health claim. More specifically, scientific evidence is required to support non-traditional health claims, while traditional evidence supports only traditional health claims. The following are examples of each type of health claim:
Non-Traditional Claim: Helps to promote alertness and wakefulness, and to enhance cognitive performance.
Traditional Claim: Traditionally used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints (e.g. sprains, bruises, joint pain).
When making traditional claims in combination products, Health Canada requires the claim to be qualified to identify the herb eliciting the action. An example of this is as follows: “Arnica is traditionally used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints (e.g. sprains, bruises, joint pain)”.
There are certain types of permitted health claims, which are substantiated using varying strengths of evidence. Health Canada allows natural health products (NHPs) to make therapeutic, risk reduction and structure-function claims whereas the US FDA permits only structure-function claims. Examples of these types of claims are as follows:
Therapeutic Claim: Helps to relieve joint pain associated with osteoarthritis.
Risk Reduction Claim: Helps to protect against the deterioration of cartilage.
Structure-function Claim: A factor in maintaining good cartilage and/or joint health.
To substantiate structure-function claims on dietary supplements marketed in the US, regulatory authorities require competent and reliable scientific evidence which has been defined by the Federal Trade Commission (FTC) as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results”. In summary, high quality scientific evidence is required to substantiate your non-traditional health claims in both the United States and Canada.
dicentra has a team of scientists who specialize in health claim substantiation. If you are looking to market your NHP for novel claims, or are looking for evidence to substantiate your dietary supplement claims, our team of experts can assist in the process.
2012 Dates for dicentra’s Free Regulatory Update Webinars
The dates have been confirmed for dicentra’s remaining quarterly free Regulatory Update Webinars:
3rd Quarter: Tuesday, September 18, 2012
4th Quarter: Tuesday, December 4, 2012
All the webinars begin at 1:00pm est
Click the link below and sign up for the webinars. This is a great way for you and your company to stay informed and avoid challenging surprises down the road.
|Natural Products Association Expo East
September 20-22Canadian Health Food Association Expo East
Visit us at Booth 2606dicentra is also a sponsor of Health Canada’s on The Regulatory Environment of Canada on September 20th from 7:30 am – 12:15pmEurope Now
Visit us at Booth 1002
Council for Responsiblie Nutrition Annual Conference
Food Regulatory & Quality Assurance Summit
dicentra Featured in Life Sciences Ontario Promotional Video
Upcoming Regulatory Update Webinar
Don’t miss our next free Regulatory Update Webinar of the year on Tuesday, September 18, 2012 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 speaker please continue to read below.
To register for the webinar please click below:
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 teleconference.
Please visit www.dicentra.com for weekly regulatory and scientific articles, special alerts and updates.
PRESENTATION TOPICS AND SPEAKER
Dr. John Harrison, Senior Government Relations Advisor at dicentra, will present on the following Canadian topics:
Heather VanBlarcom, General Counsel & Senior Regulatory Specialist for Dietary Supplements at dicentra, will present on the following U.S. topics:
GMP Promotional Video
GMP training doesn’t have to be complex, expensive and time consuming. Dedicating time and resources to in-house training, or hiring costly outside consultants isn’t the only answer.
Make it easy with GMP Online Training from dicentra.
GMP Online Training that’s easy to understand, easy to monitor, and easy on your budget.
Complying with FDA 21 CFR Part 111 – Understanding the Process of FDA Inspections, FDA Form 483 & FDA Warning Letter Responses
What is FDA Form 483? The FDA has started conducting inspections of establishments that manufacture, process, pack, or hold dietary supplements without prior notice to determine the establishment’s compliance with laws administered by the FDA. During an inspection, the FDA is looking for compliance with cGMPs (current Good Manufacturing Practices). The cGMPs are outlined in Title 21 CFR Part 111 of the Code of Federal Regulations, focusing on manufacturing processes and quality control.
The FDA Inspector records observations of non-compliance with cGMPs, if there are any. In such cases where there are observations the FDA officer will provide the establishment owner with a FDA Form 483 which includes the name of the firm, the date(s) of inspection and the observations recorded by the Inspector.
What happens after an FDA Form 483 is issued?
After an FDA Form 483 is issued the establishment is allocated 15 days in which to provide an adequate response to all identified observations. In the context of FDA language, the word “adequate” is defined as providing both corrective and preventative actions to observations, as well as setting reasonable timelines for the change(s) to be effected. If a company either does not respond within the 15 day allotted time frame or if the FDA considers the response to be inadequate, then the 483 is escalated to a Warning Letter, which is made publicly available on the FDA’s electronic reading room.
According to the FDA definition, a Warning Letter is correspondence that notifies regulated industry about violations that the FDA Inspectors have documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.
If response to FDA Form 483 is adequate
If no observations are made or an adequate response is provided to the FDA Form 483 then the FDA provides the inspected establishments with a final inspection report, called an Establishment Inspection Report (EIR), which includes:
Although an FDA inspection process can be a hassle for many companies, it does provide a great benefit in promoting an establishment as a cGMP compliant facility ensuring consumers that the establishment is producing quality dietary supplements that are safe and compliant with US FDA regulations.
In conclusion, ensuring that you are in compliance with cGMPs on a daily basis by performing regular audits with a solid quality control and quality assurance program in place can help get you ready for when the FDA knocks on your door for an inspection and possibly help avoid a troublesome Form 483 or Warning Letter.
Special Alerts, Regulatory Updates, Scientific & Regulatory Articles
|Special Alerts & Regulatory Updates|
|dicentra Quarterly Newsletter – Q2 – 2012
May 10, 2012
|dicentra is now a member of the Canadian Beverage Association
May 30, 2012
|Scientific & Regulatory Articles|
|Common Violations in cGMP Compliance Inspections for Dietary Supplements
May 14, 2012
|BARELY KEEPING THE GAS TANK ABOVE EMPTY – The Switch from RDA to EAR
May 23, 2012
|The Drafts: Pathways for Licensing Natural Health Products Making Modern Health Claims & Used as Traditional Medicines: What does it mean for your NHPs?
May 28, 2012
|Regulatory Barriers to Trade for Consumer Health Products
May 28, 2012
|Save Time and Money: How to Simplify Quality Testing Requirements for Natural Health Products
May 30, 2012
|Senator Durbin Continues To Pursue Overregulation of The Dietary Supplement Industry
May 31, 2012
|4-Methylimidazole – A Cause for Concern in Caramel Colouring?
June 13, 2012
|Magnesium Stearate -Update
June 18, 2012
|The Dietary Supplement Industry Can Breathe a Sigh of Relief, For Now
June 25, 2012
|Proposed Federal Legislation: Safe Food for Canadians Act
July 4, 2012
|Allowable Sodium Levels in Foods (Canada)
July 5, 2012
|The Failure of Dietary Supplement Manufactures to Comply with Current Good Manufacturing Practices (cGMPs) Continues to Make Headlines
July 6, 2012
|Coconut Oil – Healthy or Hype?
July 9, 2012
|cGMP Enforcement Actions Escalating in the United States
July 30, 2012
|International Trade Certificates and Future Developments
August 1, 2012
|FTC Wants to Level the Playing Field
August 9, 2012
Science and Research Updates
Barona J, Aristizabal JC, Blesso CN, Volek JS, Fernandez ML. Grape Polyphenols Reduce Blood Pressure and Increase Flow-Mediated Vasodilation in Men with Metabolic Syndrome. J Nutr. 2012 Jul 18. [Epub ahead of print]
Johnston DT, Deuster PA, Harris WS, Macrae H, Dretsch MN. Red blood cell omega-3 fatty acid levels and neurocognitive performance in deployed U.S. Servicemembers. Nutr Neurosci. 2012 Jun 28. [Epub ahead of print]
Figueroa A, Sanchez-Gonzalez MA, Wong A, Arjmandi BH. Watermelon extract supplementation reduces ankle blood pressure and carotid augmentation index in obese adults with prehypertension or hypertension. Am J Hypertens. 2012 Jun;25(6):640-3. doi: 10.1038/ajh.2012.20. Epub 2012 Mar 8.
Qin X, Xu M, Zhang Y, Li J, Xu X, Wang X, Xu X, Huo Y. Effect of folic acid supplementation on the progression of carotid intima-media thickness: a meta-analysis of randomized controlled trials. Atherosclerosis. 2012 Jun;222(2):307-13. Epub 2011 Dec 9.
Durup D, Jørgensen HL, Christensen J, Schwarz P, Heegaard AM, Lind B. A Reverse J-Shaped Association of All-Cause Mortality with Serum 25-Hydroxyvitamin D in General Practice: The CopD Study. J Clin Endocrinol Metab. 2012 Aug;97(8):2644-52. Epub 2012 May 9.
We hope you found this newsletter valuable. If you have any comments or questions please do not hesitate to contact us.
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