FDA's action in picamilon case sets bad precedent, CRN's Mister says

By Hank Schultz contact

- Last updated on GMT

FDA's action in picamilon case sets bad precedent, CRN's Mister says

Related tags: Food and drug administration, Steve mister

The declaration from FDA on picamilon that formed part of the lawsuit filed by the Oregon Attorney General sets a troubling precedent, said Steve Mister of  the Council for Responsible Nutrition.

CRN sent a letter signed by Mister to the Food and Drug Administration objecting to the way that Cara Welch, PhD, acting director of the Division of Dietary Supplement Programs weighed in the status of the ingredient in a lawsuit filed against GNC by Oregon AG Ellen Rosenblum. Mister said it is troubling that the agency made its first public declaration about picamilon in this manner, rather than airing the issues surrounding the ingredient with industry first.  And just such a forum presented itself in this case, Mister said, and the agency chose not to use it.

No prior word on ingredient

“What concerns us so much is that the trade associations had a meeting with FDA on Sept. 28.  That was the same day that Dr Welch signed this declaration.  We talked to them at that meeting that as a result of what was happening in New York that is was important that FDA was managing the interaction with the state AGs.  At the end of the day, that interaction should be about enforcing Federal law, not some state requirement,” ​Mister told NutraIngredients-USA.

“They didn’t work with us.  Instead they signed an affidavit on something the agency has never made a public statement on,”​ he said.

Mister said CRN will address the specific issues with picamilon in a separate communication.  What the letter sent yesterday focuses on is how FDA interacted with the AGs in this particular case, and what it says for the future as the newly invigorated state AGs saga plays out.

In the letter, CRN lays out the position that the questions surrounding picamilon are purely ones of legal interpretation. They do not appear to hinge upon whether picamilon presents a health risk, which could form the basis for a speedy action.

“FDA has never made any public statements with regard to picamilon: it has not released any warning letters to the companies marketing picamilon, issued any recall on this ingredient, or announced any consumer advisories on it. In fact, we are not aware that FDA has ever communicated publicly about picamilon in any regard. Moreover, we are not aware that picamilon has been the source of any significant number of adverse event reports or any other signals that it may present a public health or safety concern,”​ the letter states.

Leading, not following

Mister said there are rules of conduct that govern how and when FDA officials would take time to provide testimony in actions to which the agency itself is not a party.  Moreover, he said that past precedent is that the interests of the agency of the proper enforcement of the Food, Drug & Cosmetic Act are best served when the agency has a close cooperation with industry.  And while he acknowledged that FDA struggles with too few resources to cover its responsibilities, and that cooperating with state law enforcement agencies might be an attractive way to extend its enforcement capabilities, that interaction has to be led by the agency.

“What they are doing is they are allowing the states to set the agenda.  FDA has been very vocal about pure powdered caffeine, for example.  If they had given a state declaration on that, and if they had then relied on a state law enforcement agency to go enforce their determination that that ingredient should not be on the market, we would not have an issue with that,”​ Mister said.

“But we emphasized with FDA that they had to provide leadership. On the issue of tainted products, if FDA didn’t have enough resources to actually prosecute these people , that might be something they could cooperate with the states on,”​ he said. 

“We know there is a lot of interest right on now on the part of state AGs to get more involved with dietary supplements.  As matters stand, it sort of says to the states, you go and come up with your idea of what’s wrong with the industry and we’ll back you up,”​ Mister said.

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2 comments

FDA has it's head up its butt

Posted by Bill Ziese,

Typical stupidity. The FDA has put a limit of 99 mg of potassium (as KCl) per capsule. I buy No Salt; it's almost pure KCl and comes in a an 11 ounce container - that's three hundred eleven thousand eight hundred fifty milligrams. Waaaaay more than 99 mg.

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Issue Management 101

Posted by Jeff Nedelman,

Never got into a public pissing match with federal regulatory officials who carry badges and guns and can shut down your member company plants. This obvious lesson seems lost on the dietary supplement industry. The are the regulated, not the regulators.

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