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

FDA to Inspect Foreign Firms

Hello!

I hope this brief update finds you well.  Here in the US Summer’s heat is unrelenting and FDA is turning up the heat also.

I learned today that FDA has issued letters to foreign food facilities that they will be inspected between October 1, 2010 and September 30, 2011. What does this mean for you? 

If you are outside the US and you manufacture, warehouse or distribute food or dietary supplement products that are imported to the US, you must respond to the FDA letter or risk having your registration terminated and any imports detained at the border.  You will only receive such a letter if you are properly registered. 

If you are outside the US and are not properly registered, this move on the part of FDA could mean that your products are immediately subject to detention since FDA has announced their intention to enforce the facility registration requirement.

If you are a US company but use imported ingredients or sell imported products, your purchases may be subject to detention if your supplier / manufacturer is not registered.

The registration process is simple and can be completed online by following this link:

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm

FDA does not charge a fee for facility registration but you must provide the following information:

1. Facility name, address, phone number, and emergency contact phone number
2. Parent company name, address, and phone number (if applicable)
3. Name, address, and phone number of the owner, operator, or agent in charge
4. All trade names the facility uses
5. Applicable food product categories, as listed on the registration form
6. Name, address, and phone number of a foreign facility’s U.S. agent, and phone number of the facility’s emergency contact if it is someone other than the U.S. agent
7. Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so

At your request, I would be pleased to send you a PDF copy of the Registration form that you may mail or fax to FDA along with an electronic booklet describing the process.  If you need help with your registration, the team at Bioscience Translation & Application can help.  We can facilitate the registration process, serve as your US agent and help you with other communications with FDA. 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 and FCC to work Jointly on the Development of Wireless Medical Devices

Hello!

Last week the Food and Drug Administration and the Federal Communications Commission issued a joint statement regarding their intent to proactively address issues that arise when medical devices send patient information to physicians wirelessly.  Issues such as the reliability and privacy of the communication are of particular concern.  If the communication link is not reliable it could affect patient care and health outcomes if vital data is either incomplete or simply not received by the physician.  It is also vitally important to ensure that patient data cannot be obtained by eavesdropping or overt hacking.

You may read the agencies’ statement at: http://www.fda.gov/MedicalDevices/NewsEvents/ucm220277.htm

Bioscience Translation & Application has expert associates ready to serve you in the area of medical device regulation and we welcome your questions regarding these products.Visit us at www.BioTransApp.com.

Safe Cosmetics Act of 2010

Hello!

We thought that you would be interested in learning that the Safe Cosmetics Act of 2010 was introduced in the US House of Representatives this week.  If passed and enacted this legislation would increase the regulation of cosmetic product in the US and would affect both foreign and domestic companies.

Changes to the cosmetics regulatory system proposed in the legislation include:

1. Requiring all establishments that manufacture package or distribute cosmetics in the US to register with FDA annually and provide contact information, a description of the establishment’s activities, gross receipts, the number of employees, and the name and address of any company that supplies a cosmetic manufacturing establishment with ingredients for its products.  Only the name and address of the companies would be published;
2. Authorizing FDA to establish fees to be assessed on companies with annual gross receipts or sales of more than $1 million to fund the costs of establishing and enforcing the new regulations;
3. Requiring that all cosmetic products, including those marketed for professional use, include a complete list of all ingredients.  The law would also require full listing of ingredients on websites that sell cosmetics;
4. Requiring manufacturers and distributors of cosmetics and ingredients to submit all information they posses on the physical, chemical, and toxicological properties of ingredients, such as function and use, test results, and exposure data to FDA;
5. Require FDA to issue regulations listing ingredients identified by the Agency as “prohibited ingredients,” “restricted ingredients,” or “safe without limits” for use in cosmetics as well as a list of at least 300 ingredients that are not eligible for inclusion on the above lists due to lack of safety data. FDA must also make safety determinations for these ingredients;
6. Prohibiting companies from manufacturing, importing, distributing, or marketing a cosmetic or cosmetic ingredient if the company failed to provide information to FDA as required or if the company’s products contain non-permitted ingredients;
7. Requiring companies to notify FDA if a marketed product “is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health consequences or death to humans;” 
8. Authorizing FDA to request a voluntary recall of the affected products, issue an order for the company to cease distribution, and, under certain circumstances, require a recall or issue an emergency recall order or adulterated or misbranded cosmetics;
9. Authorizing FDA to require that cosmetics containing nano-materials be include that information on the labels;
10. Establishing an adverse health effect reporting system;
11. Requiring FDA to publish a list of “alternative testing methods” that do not involve the use of animals to test a chemical substance and that must be used in product testing where practicable.

A voluntary registration and listing program for cosmetic companies is already in place at FDA and most of the proposed requirements simply bring regulation of the cosmetic industry up to standards already required for foods, dietary supplements and other regulated products.  The requirement that FDA list the status of cosmetic ingredients could actually be helpful to industry; particularly to smaller companies who are not members of the Personal Care Product Council (www.personalcarecouncil.org), which has an enormous amount of ingredient information.   

Even though the legislative process has just begun and similar bills submitted in previous years have not gained traction and become law, is not too early for US companies to contact their Representatives regarding the proposed law.  It will also help your company’s long term future to consider implementing programs of information collection and ingredient verification, testing, etc. that help to ensure the quality and safety of your products. 

If you have questions about current Cosmetic regulations or these proposed changes, please contact us. Learn more about us at www.BioTransApp.com.

You can read more about this legislation at the FDA Law Blog: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/07/rep-schakowsky-introduces-safe-cosmetics-act-of-2010-bill-would-increase-regulation-of-cosmetics.html

The blog post also provides links to the legislation itself.

GMPs & Warning Letters for Dietary Supplement Companies

Hello!

I trust that summer is flying by for those of you in the Northern Hemisphere and I hope that winter is not too harsh for those of you in the Southern Hemisphere.

Since dietary supplement companies are now required to comply with FDA’s Good Manufacturing Practices (GMP) regulations, the agency has begun increased inspections and enforcement actions as promised.  In March the agency posted the first warning letter based on the dietary supplement GMPs. The following deficiencies in adherence to GMPs were noted:

1. Failure to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use. In this particular case the company was using an aloe vera gel but the testing methods used were not sufficient to know if the aloe were pure or if it was “a mixture of aloe, thickeners and/or other ingredients.”
2. Failure “to make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement”.  So the company had in process tests set up but those processes and tests were not relevant to the product.
3. Failure to “follow your written procedure, ‘Approval/Rejection of Raw Materials and Packaging Components’ for collecting representative samples of each unique shipment of components.”  In other words, the company had standard operating procedures but did not follow them.

The letter goes on to cite several deficiencies with the quality control program, batch records and manufacturing records.  You can read the entire letter at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm210182.htm .

Our goal at Bioscience Translation & Application is to facilitate your success.  We work in association with former FDA staffers who provide GMP and pre-inspection assistance.  Let us know if you need help complying with these regulations. Learn more at www.BioTransApp.com.

You may also be interested in attending a GMP class being offered at the Supply Side West meeting to be held in October in Las Vegas.  While I have not seen the curriculum, the course is being offered by reputable companies.  For course details visit

http://www.supplysideshow.com/2010/west/fda-gmp.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