Due to “competing priorities,” the agency provided no clarification on how it interprets the provision of DSHEA which defines drugs versus dietary ingredients.
The guidance, issued this year is a departure from common marketing practice of dietary supplements and food, and misrepresents the state of the law, CRN said.
The trade organization said the notices issued earlier this year were inconsistent with regulatory practice, and unenforceable because they violate due process.
Following an update from the agency, the trade association characterized the agency’s plan as ‘pulling back’ on its responsibility to regulate supplements.
A bill which offered a slate of protections for people with eating disorders was amended in order to remove dietary supplement restrictions from the equation.