In 2016 the FDA revised the agency’s guidance on dietary supplement labeling. This modification permits the term “dietary supplement” be the entire statement of identity for a dietary supplement. This is an error in the interpretation of the plain language of the Food, Drug, and Cosmetic Act, the plain language of 21 C.F.R. § 101.3(g); and does not comport with numerous rules of statutory interpretation. Moreover, this change violates the Administrative Procedures Act and the FDA’s rules on notice and comment. This change is a disguised rescission of 21 C.F.R. § 101.3(g) without a proper opportunity for the public to be heard under notice and comment rulemaking.
Fortin, Neal D.
"The FDA's Guidance on Dietary Supplement Naming and the Emperor's New Clothes,"
Journal of Food Law & Policy: Vol. 13
, Article 6.
Available at: http://scholarworks.uark.edu/jflp/vol13/iss2/6