Speaking to NutraIngredients-USA.com at the SupplySide East show in New Jersey last week, New York City-based lawyer Steven Shapiro said a large elephant – in the form of FDA draft guidance issued in December 2009 – was sitting in the room on this issue.
Scores of products currently on the market breached this guidance, which warned industry that if products looked like drinks, they should be marketed as drinks, and not as supplements, said Shapiro, a partner at law firm Ullman, Shapiro and Ullman.
This mattered because conventional foods/beverages and supplements were subject to different rules, he said.
“If the FDA suddenly decides to start enforcing this guidance, which runs contrary to dietary supplements legislation and to its own previous advice, there could be serious consequences for industry. If you are selling a conventional food or drink - as opposed to a dietary supplement – then novel ingredients including herbal and other botanicals must be either approved food additives or Generally Recognized as Safe (GRAS) for their intended use."
Similarly, while you could make structure/function claims about an ingredient such as echinacea in a supplement, you could not make the same claims about it in a drink as it was not GRAS or approved as a food additive, he said.
‘Serious consequences’ for industry
And just because the FDA had so far failed to take much action on the issue since the guidance was issued did not mean that the industry was off the hook, he said.
“This guidance is still out there and it’s not going away, and there are a lot of products in contravention. The question is where are they going with this?”
Historically, argued Shapiro, the FDA had advised industry – as per the Dietary Supplements Health & Education Act (DSHEA) - that it didn’t matter if a liquid dietary supplement was packaged like a conventional beverage, as long as it was labeled as a supplement.
However, the recent guidance appeared to throw this on its head by arguing that where a dietary supplement was merchandised, what it looked like, how much liquid was in it and whether it physically resembled a conventional food/drink product did matter, he said.
Outright attack on DSHEA?
“It was almost an outright attack on DSHEA, but the only comments submitted were from trade associations and FDA lawyers, not companies actually producing these products. I was really surprised that the industry did not respond to this more aggressively at the time, because it has quite significant ramifications.”
He added: “It is possible that this draft guidance may fall by the wayside and be forgotten, never finalized. But, I view it, to some extent as a test balloon. It is still out there, FDA has not withdrawn it and there has been some enforcement based on it.
“FDA may view things in the long term. If industry did not strongly oppose this draft guidance, perhaps down the road, FDA will build on the precedent and take further action?"
Supplements: Tablets, capsules and dropper bottles only?
“Clearly, the intent of the draft guidance is to narrow the dietary supplement category," argued Shapiro.
"If a liquid dietary supplement cannot be packaged in a bottle or can that is similar to a single serve or multiple serve soda, bottled water, fruit juice or iced tea package, what packages are conceivably left? The guidance seems to suggest that the FDA will no longer accept a product packaged in an eight, 12 or larger fluid ounce package as a dietary supplement—a major shift in its thinking"
He added: “Are they trying to return to the days when supplements were limited to tablets, capsules and dropper bottles?”
Frutarom USA health division vice president Laurent Leduc said this was an area of the law that didn’t seem to be very well enforced, adding: “It’s an interesting grey area; you could find the exact same product sold in both markets [foods and dietary supplements].”
Size matters
In its draft guidance document, which you can read here the FDA said it “considers a liquid product’s name, packaging, serving size, and recommended conditions of use, as well as other representations about the product, to be important determinants of whether it is represented as a conventional food and may not be marketed as a dietary supplement”.
NutraIngredients-USA.com hopes to get an update from the FDA about this issue later this week.