What’s Cookin’ Good Lookin’? FDA Issues 17 Warning Letters on 22 Products re Labeling

In what may be the first mass mailing of a letter to a manufacturer since the infamous 14 April 2nd Notice of Violation letters sent to pharmaceutical companies regarding paid search, the FDA yesterday notified 17 food manufacturers of 22 label violations on food products which follows a statement she issued in October 2009 that encouraged companies to review their labels to ensure that they were in compliance.  There is also an extensive labeling background document that was made available in 2009.  

The FDA also issued an open letter from Dr. Margaret Hamburg to the food manufacturing industry. In addition, the agency provided a very user-friendly chart that outlines the reason for each violation noted for each product so that you don't have to read each and every letter to get the idea of the problem.  

In the open letter, the Commissioner states that "improving the scientific accuracy and usefulness of food labeling" is one of her priorities.  The letters and the effort from October 2009 are centered on the "front of pack" labeling – the face of the product by which most busy consumers make purchasing decisions, and implicit in that, nutrition decisions.  She states that she hopes "that every food processor will contribute its views" on the pathway to improve the front-of-pack labeling and that the issue is planning on issuing a draft guidance related to front-of-pack calorie and nutritional labeling.  

That modus operandi should sound familiar.  In April, FDA's DDMAC issued 14 Notice of Violation letters regarding 45 brands for paid search violations.  Then in the Fall, the agency sought input from industry to devise a social media product promotion policy.  It is doubtful that the April letters were sent as a means of generating interest in the issue before a Part 15 meeting on the topic held in November and it is highly doubtful that the FDA even contemplated such a meeting at the time.  But the effect was certainly there.  The letters did get the attention of industry and they responded, not solely through trade associations, but as individual companies.

In yesterday's open letter, the Commissioner stated some, but not all of the areas of general concern that need to be addressed:

  • Nutrient content claims that FDA has authorized for use on foods for adults are not permitted on foods for children under two.  Such claims are highly inappropriate when they appear on food for infants and toddlers because it is well known that the nutritional needs of the very young are different than those of adults.
  • Claims that a product is free of trans fats, which imply that the product is a  better choice than products without the claim, can be misleading when a product is high in saturated fat, and especially so when the claim is not accompanied by the required statement referring consumers to the mroe complete information on the Nutrition Facts panel.
  • Products that claim to treat or mitigate disease are considered to be drugs and must meet the regulatory requirements for drugs, including the requirement to prove that the product is safe and effective for its intended use (Note, the Cheerios Warning Letter issued in May 2009, and the response by General Mills)
  • Misleading "healthy" claims continue to appear on foods that do not meet the long- and well-established definition for use of that term.
  • Juice products tat mislead consumers into believing they consist entirely of a single juice are still on the market.  Despite numerous admonitions from FDA over the years, we continue to see juice blends being inaccurately labeled as single-juice products.

There are many take-aways from this.   Here are just a few.   

  1. Companies that received letters have a task ahead to respond within 15 working days to the agency letters.  The communications as worded in these letters must not only address product concerns vis a vis the issues raised in the letter, but also address corporate image interests in that the public will form perceptions based on the tone of the response;
  2. Companies that have not received letters need to re-examine their labels anyway.  There is no reason to think that a second wave could not be issued.  In addition, consumers and the agencies that are in the business to protect their interests, are going to want to know what all food manufacturers are doing to reinforce responsible labeling – not just the few products affected by the letters.  So each and every food processor should now be considering a communications response irrespective of whether they have received a letter;
  3. For that reason, food processors may want to consider individual responses and statements and to begin dialog with consumers.  It may be an area in which they want to engage consumers via social media.  In any case, they will want to monitor what is being said by consumers in social media about the topic;
  4. Thought should be given now to how companies will provide the input being sought by the Commissioner's open letter in response to the draft guidance and there may be lessons in how pharmaceutical companies responded to input in the wake of the Part 15 meeting on Social Media.  Though in that instance, FDA provided a framework for responses by posing specific questions.
  5. The new FDA is highly geared to ensuring industry adheres to regulation and provides input into new directions, as evidenced by the pharmaceutical industry and social media example, and now the labeling issue for food manufacturers.  To the extent that it can, it might be a safe bet that the dietary supplement industry should start thinking about its own claims and labeling.  

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