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FDA Commission Gottlieb Indicates Future of FDA’s Role in Defining Claims Such as “Healthy”
Friday, October 20, 2017
  • As previously reported on this blog, the Food and Drug Administration (FDA) received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” – which has not changed since 1994 – to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.  In September 2016, FDA issued a request for comments on the use of the term “healthy” on food labels, and by April 26, 2017, the Agency received over 1,000 comments.

  • On October 15, 2017, the Wall Street Journal (WSJ) interviewed FDA Commissioner Dr. Scott Gottlieb about the direction of the FDA under the current administration.  Commissioner Gottlieb acknowledged that claims should not be defined in the “absence of scientific framework” or by the courts without FDA review.   Commissioner Gottlieb went on to explain that FDA intends to “adjudicate some of the important claims that product developers want to make on labeling that could be important in informing consumers.”  Commissioner Gottlieb also stated “[w]e’re taking a more wholesale look right now inside the agency at the full range of claims that product developers want to make on labeling or are making on labeling where FDA hasn’t played a role, and making a decision from a public-health standpoint where it is important for us to step in.”  With regard to the “healthy” claim Commissioner Gottlieb stated that FDA “might make a decision that the claim is more of a commercial claim and doesn’t really convey something important from a public-health standpoint to a consumer.”  This could imply that FDA may not be taking action on “healthy” claims in the near future.

  • Commissioner Gottlieb’s interview suggests the Agency will continue to review and develop labeling claims to promote public health and prevent outside forces from defining those claims but will not address those claims that they view as simply commercial.   This presumes that companies will want to use defined claims that FDA has decided have an impact on public health as opposed to commercial claims that may in the company’s view better promote their products value to the consumer.

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