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

Suit Against FDA Could Affect Hand Sanitizers

The most amusing title I have ever seen on an FDA guidance document is “Is it a Cosmetic, a Drug or Both? (Or is it soap?)” http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm. This guidance addresses common misconceptions about how certain products are regulated.  Hand sanitizers and antibacterial soaps are examples of products whose regulatory status is confusing to many and so we have decided to send this update to our friends and clients working in both the drug and cosmetic sectors.

A recent blog post from Hyman & Phelps discusses a law suit in which the Natural Resources Defense Council is suing FDA to force the agency to finalize the over the counter drug monograph for tricolsan and triclocarban, common ingredients in many hand sanitizers and antibacterial soaps.  Work began on this monograph in 1974 and has languished since 1994; NRDC claims the delays are unnecessary. While not final, FDA states that the monograph reflects the agency’s opinion on the topic and no matter what the result of this lawsuit, companies that comply with the tentative monograph will not have to reformulate their products or change their labeling.  The tentative status of the monograph has been exploited as a loophole of sorts by some companies that market hand sanitizers and antimicrobial soaps with triclosan, triclocarban and other nonmonograph active ingredients. If the NRDC prevails in this case and FDA rapidly finalizes the monograph, companies using active ingredients other than isopropyl alcohol, denatured alcohol, povidon and various forms of iodine will have to reformulate their products.

To read more about the legal issues surrounding this lawsuit, please read the entire Law Blog post at:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/08/nrdc-sues-fda-for-failing-to-take-action-on-triclosan-and-triclocarban.html

FDA Warning Letters to Food Companies

Hello!

Everyone who eats believes they know at least a little bit about food labels; some even think they understand them completely. But folks in the food business know that labels can be surprisingly complicated and sometimes even frustrating.

In the past several months FDA has issued a number of warning letters to food companies and many of these letters list labeling violations:

A letter to Mickey’s Snacks notes that the product is mislabeled because not all ingredients are listed and allergens have not been declared.  The presence of ingredients derived from or including Milk, Wheat, Soy, Eggs, Peanuts, Tree nuts, Fish and Crustacean shellfish must be clearly identified.  The species of fish and tree nuts present must also be declared.  You may read the entire warning letter at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215767.htm

Twin Oaks Community Foods was cited for many violations, including improperly using the nutrient content claim, “Saturated fat free” and for not listing calories from fat or the levels of trans fats in the product.  The nutrition facts box was also not properly formatted.  Read the details at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm216242.htm

Yet another recent warning letter (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm216262.htm) enumerates many GMP violations and also cites Oxford Falls, Inc., a producer of condiments and salad dressings, for failure to list all the subingredients that make up the ingredients that they add to their product. One specific example was that the company used Worcestershire Sauce in some products.  Since this sauce is made up of two or more ingredients, each and every one of them must be listed.   This warning letter further cited the company for improper serving size declarations. Serving sizes are set forth in FDA food regulations and must you must use the standard established for your product.  The most interesting violation noted in this letter was the failure to list a zip code as part of the company’s address.  The inspector that wrote this letter is clearly very detail oriented and did not rely on the statement that appears in every FDA warning letter, “The above violations are not meant to be an all-inclusive list of deficiencies…”

Warning letters are serious matters.  Companies that receive them are given 15 days to respond to FDA’s concerns.  Failure to adequately respond can result in seizure of product, injunctions and other actions.  Labeling problems can greatly impact your business.  FDA inspection and enforcement is on the rise and while importers have typically faced a greater chance of inspection, it is becoming more likely that companies in the US will have their facilities inspected after recent high-profile food contamination issues.  Increased inspection means increase scrutiny of labels, since they serve as a sort of table of contents guiding the inspector to areas of concern in your manufacturing process.

At Bioscience Translation & Application we hope that you never face an inspection you are not ready for and we work with our clients to ensure that their product ingredients and labels comply with FDA regulations. We welcome your questions regarding Food regulations including those for baby formula, pet food, medical foods and foods for special dietary uses. Visit us at www.BioTransApp.com