The agency issued a warning about “Neptune’s Fix” supplements, and all others containing the substance, which can serious, potentially lethal side effects.
The agency found that several “tejocote” supplements were adulterated with the toxic botanical, following a similar investigation in September of last year.
The first-of-its-kind state bill, which bans the sale of “weight loss” and “muscle building” supplements to minors, is slated to go into effect in April 2024.
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.