The FDA’s warning letter to the maker of melatonin-laced Slowtivate Relaxation Drink has reignited the debate over the legal line between liquid dietary supplements and conventional beverages - and should make some firms very nervous - say lawyers.
Speaking at the Nutracon conference in Anaheim yesterday, Colorado-based attorney Justin Prochnow said the letter – sent late last year – was a “significant development” as it indicated the FDA was prepared to enforce draft guidance from 2009 which said that if products looked like drinks, they should be marketed as drinks, and not as supplements.
One-off or the start of new crackdown?
What we don’t yet know is whether the letter represents the start of a fresh crackdown on firms that are marketing drinks as supplements or whether the FDA just has a problem with melatonin, he said.
However, any firm marketing a dietary supplement containing non-GRAS ingredients (such as melatonin) that was packaged like a conventional beverage should be very nervous, said Prochnow.
“This looks like a big warning shot across the beverage industry. This is a letter that everyone in the beverage industry needs to take notice of.
“It will be really interesting to see if the FDA follows up on this as if you look at the functional beverages aisle, half the products in it are sold as dietary supplements.”
Elephant in the room
The guidance, which was published in 2009 – but has not yet been formalized into a final rule – has been sitting in the industry’s living room like a large white elephant ever since, added Manhattan-based attorney Steven Shapiro, who shared the podium with Prochnow.
If the FDA decided to start enforcing the guidance in earnest, there could be serious consequences for industry, he added, as you can’t simply switch from marketing your product as a supplement to selling it as a beverage if your ingredients do not have the relevant regulatory approvals.
“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,” said Shapiro.
And just because the FDA had only sporadically enforced the guidance via warning letters did not mean that the industry could afford to ignore it, he said.
“This guidance is still out there and it’s not going away, and there are a lot of products in contravention.”
Historically, argued Shapiro, the FDA had advised industry that it didn’t matter if a dietary supplement was packaged like a conventional food or beverage, as long as it was labeled as a supplement and featured a ‘supplement facts’ panel.
However, its 2009 draft 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 itphysically resembleda conventional food/drink productdidmatter, he said.
“Clearly, the intent of the draft guidance is to narrow the dietary supplement category.It 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.
“Are they trying to return to the days when supplements were limited to tablets, capsules and dropper bottles?”
In its draft guidance document , 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”.
Asked to explain its apparent u-turn, an FDA spokesman told NutraIngredients-USA last year that comments sent in by the trade in response to the 2009 draft guidance had "raised several complex legal questions that we are considering".
When asked why the FDA had not been more aggressive with enforcement given that it had warned of a rise in beverages inappropriately sold as dietary supplements, he said the justification for such action had to be considered “in light of competing priorities and the limited resources available to FDA”.