The suit, filed last week by Oregon AG Ellen Rosenblum, cited GNC for the sale of dietary supplements alleged to contain illegal dietary ingredients, specifically picamilon and BMPEA, alternately listed as Acacia rigidula. The suit seeks significant penalties for what the OR AG alleges is violation of that state’s consumer protection statutes.
Risk quotient raised
The suit is unlikely to be the last of its kind, said former Maryland AG Doug Gansler, now a partner in the law firm BuckeySandler LLP. This latest suit, combined with the actions of NY AG Eric Schneiderman over the past months which targeted GNC along with other firms, means dietary supplement companies are operating in a new environment, he said.
“There is absolutely more risk now to herbal supplement companies than there was nine months ago. Attorney General Schneiderman really woke things up. The thought has always been for state AGs is that the Federal government often lags behind on it enforcement responsibilities and there is more that can be done on the state level more efficiently and effectively,” Gansler told NutraIngredients-USA.
Picamilon is a version of the neurotransmitter GABA that has been marketed as a drug in other countries. BMPEA is a stimulant-like ingredient that FDA had already stated in a series of warning letters sent out in April is not a dietary ingredient. The agency told NutraIngredients-USA in early October that picamilon is not a dietary ingredient.
Plethora of fence-sitting ingredients
The question becomes, what of the many other ingredients on the market that could be construed to fall into the space that picamilon and BMPEA occupy? FDA is on the record as saying that it believes that there are many ingredients currently for sale which should have undergone the New Dietary Ingredient notification process and have not. It is clear that a number of ingredient suppliers are relying on the thinnest of reeds in asserting the Old Dietary Ingredient status of substances that they have brought to market in recent years. (A number of ingredient developers seem to have asserted GRAS status for their ingredients as a way to sidestep the NDI/ODI question altogether.)
“I think this raises a substantial risk,” said attorney Marc Ullman, of counsel with the firm Rivkin Radler LLP. “Companies would be well advised to review their catalog of what they sell and what they carry.”
Making sure its legal
Attorney Jason Sapsin said as an urgent matter companies should review their ingredient verification practices, as a subsidiary matter to the usual identity testing procedures called for under GMPs. After all, it doesn’t offer much protection to adequately verify the identity of something that the agency might subsequently assert shouldn’t have been on the market in the first place.
“If you are going to really pay attention to dietary supplement regulations you have got to look hard at the underlying ingredients. I don’t see the current situation as especially risky if you are doing two very basic things: One is getting the suppliers to verify that the ingredients they are offering for use in dietary supplements are in fact qualified dietary ingredients; Step two is performing some sort of verification check to make sure that assertion is true,” Sapsin said.
“At least as it has been reported in the press, people at GNC are aware that at least one of these ingredients had never been the subject of an NDI. The question becomes, what did they do afterward? If we are to believe the Oregon AG, they did nothing,” he said.
That raises the question of FDA’s long delayed NDI guidance. This document, issued first in draft from more than four years ago, is currently being revises into a new draft that the agency says will be released “soon”. FDA has been saying “soon” on this subject for more than two years. Yet the agency has been using some of the principles contained within the draft version, especially on the question of nature identical substances, as part of enforcement actions such as warning letters. This approach leaves companies like GNC in the lurch, without a firm understanding of what’s allowed and what isn’t. Ad hoc determinations via the text of warning letters is really not enough, the company said.
In a statement on the suit issued last week, GNC said on the matter of picamilon and BMPEA, “As a matter of law, this critical legal issue remains undetermined as neither FDA nor any court has issued a legally binding determination of the status of these ingredients.”
“There needs to be a clear delineation about which products are permissible and which are not. It would seem to be unfair to hold companies liable for ingredients that have not been clearly delineated as impermissible,” Gansler said.