The FDA said it issued the draft guidance on the matter because of the rise of beverages being marketed as dietary supplements with unauthorized novel and high-dose ingredients and the labeling implications that follow from that.
But in comments submitted to the FDA yesterday, CRN’s senior vice president of scientific and regulatory affairs, Andrew Shao, PhD, said the FDA guidance was confused and inappropriately tried to deal with the divide between conventional foods and dietary supplements on one hand, and labelling issues on the other.
Flawed logic
Shao said the guidance employed “flawed logic” in emphasizing the percentage of total daily fluid consumption as a means to distinguish a dietary supplement from a beverage as it was unclear what “a significant part” of that volume was.
“In CRN’s opinion, the volume contributed by a product should not be the sole determining factor in whether it is deemed a dietary supplement or conventional food,” Shao wrote.
“Additionally, basing a limit on consumers’ typical or recommended daily consumption sets a troubling precedent. Should products be categorized by the percent of energy they provide on a daily basis (e.g. % calories vs. 2000 calorie/day diet)? Or the percent of the Daily Value for a given essential nutrient(s)? This represents a slippery slope that presumably FDA did not intend.”
He said volume should be scrapped as a, “sole determinant of whether a product is a beverage of dietary supplement”.
The FDA had also mixed labelling claims into the guidance, he said, when legitimate labelling issues should be addressed separately.
Head on
New York-based legal firm, Ullman Shapiro and Ullman, also submitted comments that questioned volume as a guiding criteria.
“If FDA has a legitimate safety concern over the purported ‘growth in the marketplace’ of novel ingredients, such as added botanical ingredients or their extracts, being added to products at levels in excess of their traditional use levels, then FDA should address the safety issue ‘head on’, whether the ingredients are being consumed in products marketed as dietary supplements, conventional foods or beverages,” Steven Shapiro and Marc Ullman wrote.
“The FD&C (Federal Drug and Cosmetics) Act provides more than adequate authority for FDA to remove unsafe ingredients and unsafe products from the market...”