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

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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

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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

Insight from and FDA Staffer

Hello!

This message is going out to clients & friends of Bioscience Translation & Application.  A few days ago I sent the following tweet on Twitter:

Interesting talk w FDA staff-Lots of new inspectors & General Counsel is signing off on warnings & actions much faster-expect more activity!

I’ll flesh it out for you.  In an informal conversation with a current FDA staff member I learned that the agency is expecting to issue many more warning letters and to follow up on those warnings much more quickly.  Why is this?  First, last fall the agency hired hundreds of new inspectors.  This was in response to the many issues that had come up previously—adulterated heparin and food ingredients to name only two. 

The second and probably most important reason we should expect to see much more enforcement activity from FDA is that with the change in administration, the Health and Human Services Office of General Counsel, which must approve every warning letter and other action, is processing these actions at lightening speed. In the past, warning letters could wait six months or more for approval.  However, a warning letter that went out in early June 2009 was the result of an inspection that took place in mid-May 2009. 

The person I spoke with was delighted with these changes and hopeful that FDA will be able to readily fulfill its mandate to protect public health, particularly since the agency is expecting a 30 to 50% increase in their operating budget.

Since no one is perfect, what does this mean for you and your company?  Do you need to tighten up your GMP processes—perhaps review SOPs?  Is it time to review your marketing programs and labeling?  Contact us if you think you need to do anything other than relax and enjoy summer! www.BioTransApp.com