Identity & Quality Testing for Dietary Supplement GMP Compliance

I hope that you have been well.  The FDA remains busy and last month I attended a conference that included a session on FDA enforcement and compliance for dietary supplements.  The speakers included Jennifer Thomas, acting director, Office of Compliance, CFSAN, US FDA; Ralph Tyler, chief counsel, Office of Compliance, US FDA and Eugene Thirolf, JD, director, The Office of Consumer Litigation, US Department of Justice, whose office prosecutes cases developed by FDA.

Two very interesting comments were made by Ms. Thomas:  First she noted that FDA plans to bring enforcement activities against dietary supplement manufacturers who use aseptic processing methods but are not properly registered.  This means companies that make liquid and gel form supplements in hermetically sealed containers.  Such operations must be registered with FDA’s office for Low-Acid and Acidified Canned Foods (http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm).  The name of this office may have lead many such producers to think the regulations did not pertain to them.  We have recently helped a company file the proper paperwork and we can help you too if needed.

The second very interesting comment by Ms. Thomas was, “…and don’t even think about using the word antioxidant on the label.”  During the question and answer period I asked Ms. Thomas what that comment meant.  She admitted to using a bit of hyperbole but went on to explain that FDA is adamant that only Vitamins A, C & E and the mineral Selenium (ACES) are antioxidants and that the agency would be cracking down on antioxidant claims used for other nutrients. Many of you have had conversations with me on this very topic.  I think it will literally take an act of Congress to get nutrients other than ACES recognized as antioxidants—so write your Congressmen!

My assistants and I continue to monitor FDA warning letters—many recent ones cite dietary supplement companies for failing to do testing to confirm the identity of the ingredients they are using. Don’t let this happen to you. To learn about identity testing you may wish to ‘attend’ the free webinar from Natural Product Insider:

Establishing Identity and Quality Testing Programs for Compliance with the Dietary Supplement cGMPs

Tuesday, December 14, 2010 at 2:00 PM EST

Companies that manufacture and distributed dietary supplements in the U.S. must now comply with final FDA current good manufacturing practices (cGMPs) related to the identity, purity, strength and composition of products. However, FDA’s initial inspections have found serious problems related to testing and documentation. During this Webinar, learn from the experts on how to improve approaches to identity and quality testing for GMP compliance. FDA’s Carl Reynolds will discuss component regulatory specifications and provide an overview of FDA expectation regarding this aspect of cGMP compliance; Frank Jaksch will discuss the importance of authenticated reference standards for identity testing; and Cynthia Kradjel will discuss how to develop FTNIR methods that are fit for purpose.

http://event.on24.com/eventRegistration/prereg/register.jsp?eventid=265144&sessionid=1&key=32B03820DD47F2A1BFC21B8C8FD289DA

As the end of year approaches we at Bioscience Translation & Application stand ready to help you meet your 2010 project goals.  Contact us today for help with FDA compliance questions on foods, dietary supplements, cosmetics and over the counter drugs. Visit us at www.BioTransApp.com.

Recent insights from FDA Warning Letters

Once again I’d like to share information about FDA’s recent warning letters. This time several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling.

The first involves the use of the claim “0 grams trans fat”.  In a warning letter to David’s Cookies of Fairfield, NJ, FDA stated that “0 grams trans fat” is a nutrient content claim and is “not made in accordance with the applicable requirements.”  There are no authorized nutrient content claims for trans fat. Many of you will recall our recommendation that the statement, “0 grams trans fat per serving” be used since it is a statement of fact.  You may read the entire warning letter at:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224888.htm

There were two warning letters to large corporations regarding claims relating to green tea.

In their letter to Unilever regarding Lipton’ Green Tea, FDA took exception to claims made on the company website regarding links to green tea and heart health/cholesterol levels. The agency takes the position that Lipton is promoting the product as an unapproved new drug due to these claims.

(Read the letter at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224509.htm)

Both the letter to Unilever and a letter to Cadbury regarding their Green Tea Ginger Ale discuss the agency’s objection to the use of the term “antioxidant” in relation to green tea.  FDA only recognizes Vitamin C, Vitamin A, Vitamin E and Selenium as antioxidants. We typically suggest that our clients discuss the ‘antioxidant activity’ of nutrients other than A, C, E and selenium.  The Cadbury warning letter regarding their Green Tea Ginger Ale can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224571.htm) .

These recent warning letters are interesting because they warn about claims that are really quite common in the US grocery market.  In fact, these claims that are so common that when we have warned our clients about them, they frequently say, “but everybody says that!”  These letters demonstrate that the agency is perhaps catching up with the marketplace. This is most likely because the 600 to 800 new inspectors hired a few years ago have mostly completed their training.

There are many things to consider when writing FDA compliant claims.  Armed with 12 years of experience with FDA regulations, we at Bioscience Translation & Application stand ready to help you understand the many nuances to this task. Visit us at www.BioTransApp.com