The petition, filed on May 14 by the newly-formed Organic & Natural Health Alliance, asks FDA to extend CFR Part 111 requirements to firms dealing with raw materials. It also asks the agency to clarify the regulatory responsibilities of private label manufacturers.
Omission in original rule
“The citizen’s petition that was filed is in concert with our 2007 position on this matter. We were surprised then by FDA’s decision to separate the dietary supplement and dietary ingredient components of GMP compliance for the simple reason that we believe that all parties within the supply chain are better served to operate under a unified regulatory structure. Our opinion on this has not changed,” Loren Israelsen, president of the United Natural Products Alliance told NutraIngredients-USA.
“Citizen’s petitions are a long, slow process, and unfortunately, because of that, the petition will not directly address or provide resolution to the sense of urgency that the industry is experiencing due to the New York attorney general’s investigations,” he said.
The ONHA was formed last year with the ostensible mission to define what ‘natural’ means and to defend that definition. The nascent group made waves recently when it became the first trade organization in the dietary supplements sphere to meet with New York Attorney General Eric Schneiderman. While that move raised some hackles among industry observers, the present action is just common sense, stakeholders say.
“I wish the FDA had included ingredient suppliers right from the beginning when they issued the GMP final rule,” said Suzanne Shelton, a Chicago-based PR consultant who has been active in the industry since before the time of DSHEA.
“If you are raising the bar on the quality of ingredients righty from the start it will raise the quality right through the supply chain. We know there is substitution and some low quality out there. I want to see more testing. I want to see higher standards. If the FDA would extend those rules to include ingredient suppliers it might help,” she said.
Level playing field
George Pontiakos, president and CEO of raw material supplier BI Nutraceuticals, said the idea of extending GMP standards is fine in principle, if it were enforced uniformly. Already there is an imbalance in the market in that some companies like BI offer high quality, compliant ingredients whereas others do not, he said.
“This industry has a habit of happy talking about things like quality and then running around chasing the cheapest stuff that’s out there,” Pontiakos said. “We have no objection in going to 111. We think that is some ways it would be helpful. BI could already pass a 111 audit easily. We already comply though we are not audited to it.
“But the challenge is it costs money. It puts me in a disadvantaged position if people are going to buy the absolute cheapest stuff. It’s a shame we have to ask for this level of scrutiny because we can’t police ourselves as an industry. From a philosophical viewpoint I'm against more industry regulation. The challenge is that a large portion of the industry is not driven by these mores," he said.