Keller and Heckman LLP in their blog, alerted us to a recent Wall Street Journal interview of FDA Commissioner, Dr. Scott Gottlieb. Both the original interview and K&H’s take aways are worth reading, but here’s some key points.
A Healthy claim might simply be a commercial claim, and thus not a FDA regulated claim.“We might make a decision that that [healthy] claim is more of a commercial claim and doesn’t really convey something important from a public-health standpoint to a consumer.” (Gottlieb)This begs the question if its not a claim and just a commercial claim, then will “Healthy” simply be a type of puffery. Remember puffery is just a grand claim that the public would never actually consider to be true….such as the phrase “The worlds greatest hamburgers!” So is the phase “The worlds healthiest hamburgers!” just a commercial claims and ok to use? Short answer – consult your attorney.
The FDA considers claims (i.e. label and labeling claims) to be a matter of public health.“This [food label regulation] isn’t just an issue of transparency. This is an issue of public health.” (Gottlieb)“You [WSJ Editor, Jacob Bunge] talk about them as transparency initiatives. I look at them as public-health initiatives.” (Gottlieb)Its worth noting the phrase “public-health” is repeated 9 times, which only emphasizes how much the FDA’s mission, which begins “The Food and Drug Administration is responsible for protecting the public health by…”, is engrained into their culture,
The FDA doesn’t like that states, like California, end up regulating.““Healthy”…is a subject of litigation in California.“When certain claims that might be important to providing information to consumers get made in the absence of a scientific framework and get litigated in state courts and torts, outside our review, I think that isn’t what was intended.” (Gottlieb)
“Healthy” generates a bunch of industry angst.Keller and Heckman point out, “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.”
Bottom line: The word “healthy” is clearly defined by FDA’s current 21CFR101.55, open to consumer’s interpretation, and subject to litigation on many fronts.