The Food and Drug Administration (FDA) says feedback it has received about its December 2009 draft guidance clarifying where a liquid dietary supplement ends and a conventional beverage begins has raised “complex legal questions”.
The FDA was talking to NutraIngredients-USA.com following an article we ran this week in which a leading food lawyer said the guidance ran contrary to dietary supplements legislation and to the FDA’s own previous advice.
Complex legal questions
A spokesman said the FDA was still reviewing comments submitted by legal experts, industry and trade associations in response to the draft guidance, adding: “The comments raised several complex legal questions that we are considering.”
Respondents had also raised challenging questions on “how the draft guidance fits within the totality of FDA's information on the topic”, confirmed the spokesman.”FDA is still reviewing the comments and upon completion of that review will decide the next steps.”
This could involve” finalizing the guidance as-is, modifying and finalizing it, or withdrawing it”, he said. However, the FDA had not set a deadline for completing its review.
When asked why the FDA had not been more aggressive with enforcement action given that its draft guidance had warned of a rise in beverages inappropriately sold as supplements, he said the justification for such action had to be considered “in light of competing priorities and the limited resources available to FDA”.
Elephant in the room
In the controversial draft guidance document FDA said it “considers a liquid product’s name, packaging, serving size... to be important determinants of whether it is represented as a conventional food and may not be marketed as a dietary supplement”.
Previously, however, it had advised industry – as per the Dietary Supplements Health & Education Act - that it didn’t matter if a supplement was packaged like a conventional beverage, as long as it was labeled correctly, New York City-based lawyer Steven Shapiro told NutraIngredients-USA.com last week.
“If the FDA suddenly decides to start enforcing this guidance … 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.
"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?
“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?