The issue has been percolating ever since the Food and Drug Administration issued its 2005 Dietary Supplement Labeling Guide, as attorney Wes Siegner, a director at the law firm Hyman, Phelps and McNamara, pointed out in a recent blog post. In the guidance, FDA seems to directly contradict itself and the underlying law on the matter of how to label a product as a supplement in a compliant manner.
Both sides of coin
For example, in a 1999 communication, FDA said that dietary supplements would heretofore be identified with a Supplement Facts panel on the back. On the front, FDA said, “A statement of identity will appear on the front panel of the product label. The statement must use the terms 'dietary supplement' or a term identifying the contents of the product, such as ‘Vitamin C supplement’ or ‘Herbal supplement.’ But in a question-and-answer section of the 2005 guidance the following statements appear:
“Can the term "dietary supplement" by itself be considered the statement of identity?
“No. This term by itself is not appropriately descriptive to be a statement of identity.”
So is identifying a product as a ‘dietary supplement’ on the front label, or using a suitable modifier such as ‘Vitamin C supplement,’ and putting a Supplement Facts panel on the back enough? In practice, yes; but not according to the letter of those certain rules and regs, Siegner said.
“If you look at the guidance you would determine that their position is that it is not enough,” Siegner told NutraIngredients-USA. “The second place you would look is their regulation. If you read the preamble to the regulation, it makes it clear that FDA’s intent is that it is enough. The one that really matters is the statute, and the most clear reading of that is that ‘dietary supplement’ on its own is enough.”
Ivan Wasserman, an administrative partner in the Manatt law firm, said he’d noticed the labeling glitch, too, and as others have done, shrugged it off.
“I’ve seen that over the years and I’ve thought to myself, ‘that’s not right.’ The vast majority of the products out there use dietary supplement to identify the product,” he said.
Potential lawsuit risk
The regulation glitch has not seemed to have impeded the industry, but it could serve as a point of risk in class action lawsuits, both Siegner and Wasserman said. And the recent Supreme Court ruling on the Affordable Care Act, a case that hinged on what was meant by the phrase "established by the state," shows that big legal mountains can grow from humble mole hills of language.
“I could certainly see class action lawyers trying to grasp at anything. While there is no private right of enforcement on the federal law, in California if a company is in violation of the Food, Drug & Cosmetic Act, that is a violation of California’s consumer protection laws and those laws do have a private right of enforcement and the company can be sued. That’s why you see all of these suits in California. I don’t think it would hold up in court because a court would see through the error in guidance, but I could see it included as part of a kitchen sink-type complaint,” Wasserman said.
“They are not really paying attention to the other parts of this. They are just looking at the guidance and assuming that’s the law,” Siegner said.
So, if the 2005 guidance is wrong in this respect, what are the prospects for getting it fixed? Murky at best, Siegner said.
“As far as I understand, everybody at FDA agrees that this is wrong. When I talked with (former FDA official) Robert Moore about this, he said that it is not likely to get fixed because it is not a priority. I was given to understand that the people who wrote the 2005 guidance weren’t sufficiently up on the issue and they just made a mistake. They ought to fix it,” Siegner said.