FDA Draft Guidance on Beverages Marketed as Dietary Supplements

As 2009 draws to a close FDA continues their ramped up enforcement activities based upon new guidance documents and letters to industry.  A draft guidance document published on December 7, 2009 lets us know that FDA is eyeing functional beverages and liquid dietary supplements for future enforcement activity. 

The full title of the draft guidance document is, “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods” and can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm

FDA made some very interesting statements in this document.  First, the agency notes that there has been a growth in the marketing of dietary supplements that are packaged and labeled as beverages.  Beverages are considered ‘conventional foods’ and by definition are not dietary supplement products.   Second, the agency notes increased marketing of “beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.”  Many of our clients have been dismayed when we have informed them that certain ingredients, that can be found in blockbuster, name brand products, are not permitted for use in their products.  The new guidance document tells us that those products’ days are numbered.

The guidance document outlines factors the agency looks at to determine whether a liquid product is a conventional beverage or a dietary supplement. 

1. Packaging – if it looks like a conventional beverage package, it may be a beverage
2. Serving size or the volume in which they are intended to be consumed.  A standard beverage serving size is one cup (8 oz)  or 240 ml
3. Product or brand name, terms such as “beverage,” “drink,” “water,” ‘juice,” or similar terms represent the product as a conventional beverage
4. Recommended conditions of use.  Products to quench thirst or to refresh would certainly be considered beverages but the agency did not elaborate on other uses that they consider related to conventional beverages.
5. Statements about the product in labeling or advertising. 

The agency has asked for comments within 60 days of the December 7^th proposed guidance.  You may submit comments to http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a62af4 .  If you would like to submit your comments anonymously, please send them to Bioscience Translation & Application and we will submit them in a consolidated document.

Dietary Supplement GMPs and 100% Identity Testing

Hello!

Many of our dietary supplement clients have struggled with complying with the Good Manufacturing Practice Regulations FDA wrote the industry.  The following link takes you to an article in The Natural Products Insider that discusses the agency’s view and includes a video of Vasilios Frankos, Ph.D., director of the division of dietary supplement programs at FDA, discussing his views on GMP implementation at Supply Side West in November.

The article discusses the concept of 100% identity testing as well as the need for written records of all procedures used for the manufacture of dietary supplements.  Read the entire article and watch the video at

http://www.naturalproductsinsider.com/news/2009/11/fdas-frankos-discusses-agencys-gmp-expectations.aspx

If you have questions regarding GMPs or any other aspect of FDA regulations, please do not hesitate to contact us.

Nutritional Genomics

Hello!

I will be speaking at the Nutritional Genomics Conference at California State Polytechnic University, Pomona CA, November 12^th – 14^th. 

What is nutritional genomics?  It is the study of the impact of diet on health through gene expression. Just as some genetic markers can indicate a person’s risk for some diseases, the emerging field of Nutritional Genomics seeks to understand whether we can learn what foods positively (or negatively) effect our health.

The ultimate goal of the conference is to use whole foods in our diet to prevent some of the catastrophic health outcomes currently overtaking our children and impacting their future health and longevity.  I will be speaking on Nutritional Genomics and the Future of Food Labeling

Click this link to learn more http://www.csupomona.edu/~nutrigenomics/conference.shtml

I would love the opportunity to meet with you if you are attending the conference or are in the greater Los Angeles area.  Please contact me to set a time to meet.

New FDA Guidance on Labeling Sweeteners

Hello!

Everyone is aware of today’s trend towards natural foods. Many manufacturers now substitute refined sugar with other cane products including “evaporated cane juice”. Yesterday the FDA issued a new guidance on labeling foods containing this ingredient. (See  http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm181491.htm.)

The guidance states that in FDA’s view “evaporated cane juice” is not the common or usual name of any type of sweetener; that the liquid from cane sugar does is not a juice and that the ingredient is appropriately labeled as “dried cane syrup”.

Cane syrup has a standard of identity defined by regulation in 21 CFR 168.130

“(a) Cane sirup is the liquid food derived by concentration and heat treatment of the juice of sugarcane (Saccharum officinarum L.) or by solution in water of sugarcane concrete made from such juice.”

A portion of the guidance discusses the notion that “juice” comes only from fruits and vegetables and that sugar cane is neither.  It is interesting to note that FDA’s definition of cane syrup conflicts with this portion of the guidance in that it calls the liquid expressed from sugar cane “juice”.  All regulations are subject to interpretation and at times, ideas that seem clear to one are not clear to another. You can rely on us to provide you with expert help navigating the possible interpretations of regulations and for help labeling sweeteners or any other ingredient. Contact us for all your FDA or USDA regulatory issues.

Reportable Food Registry

Hello!

I received the following email from FDA today and wanted to pass it along to you.  Please let me know if you have any questions.

The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.

The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. These people are termed responsible parties.

A responsible party:

1. Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
2. Must submit initial information; followed by supplemental reports
3. Must work with the FDA authorities to follow up as needed

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.

The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued on September 8, 2009, announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR.

For more information, please read the RFR Guidance at www.fda.gov/ReportableFoodRegistry.

Court Rules Against FTC in Supplement Claims Case

Hello!

You may find the story from FoodNavigation.com that is pasted below interesting.  It involves LaneLabs, a supplement company that is under a consent decree due to making false claims on dietary supplement products.  The FTC brought a suit against them due to new claims they were making stating that these claims violated the consent decree; however, the court ruled that the company indeed had data to substantiate the claims they were making and further stated that the company had made efforts to ensure compliance by conducting studies and hiring a compliance officer.  It is also important to note that the court found that FTC did not bring evidence that consumers had complained about the products or had been harmed.  The court also stated that the FTC and LaneLabs had a difference of opinion when it came to interpreting the data supporting the claims.

It is very rare for FTC to lose this type of case and demonstrates a point we often discuss with our clients:  It is possible for experts to disagree when interpreting claims, regulations and scientific studies but good faith efforts to be compliant have value.  Remember to always have a file of data regarding the structure function claims you make about your food or dietary supplement products. This file should include both supporting and contradictory studies and an analysis of the strength of the overall data.  This data will help you craft claims that are compliant and be ready to answer any questions FDA or FTC may raise.  I have worked on only one case where the FDA disagreed with our interpretation of the science supporting claims that were being made.  Because the company involved had a data file on claim substantiation, we were able to respond to the FDA warning letter very quickly.  We sent them a number of articles and never received a follow up complaint or regulatory action.

At Bioscience Translation & Application we are always ready to help you evaluate your marketing materials for regulatory compliance. We also offer claim substantiation services.  While we hope you never need it, we are also able to provide support in the event FDA or FTC takes issue with your claims. Learn more at www.BioTransApp.com