Extending GMPs to ingredient suppliers would fix gap in original rule, stakeholders say

By Hank Schultz

- Last updated on GMT

Extending GMPs to ingredient suppliers would fix gap in original rule, stakeholders say

Related tags Dietary supplement Fda

A recently filed citizen's petition asking FDA to extend GMP requirements to ingredient manufacturers met with a cautious but generally positive reception among industry stakeholders. Having ingredient suppliers stand outside this aspect of the law was never a very satisfactory solution, they say.

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

GMPs

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.

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1 comment

No Surprises

Posted by Scott Steinford,

This petition should come as no surprise to any reputable ingredient manufacturer. Top tier manufacturers have been working towards this inevitabilty of acountabilty for years and have been further assisted with respected 3rd party certifications such as those from USP and NSF. I agree with Suzanne Shelton in that it would have been best to have had the ingredient suppliers to be transparent and accountable for 111 compliance from the beginning but the challenge of enforcement still remains. DSHEA deferred enforcement and accountability to the brand holders but that fact has not insulated the large volume of ingredient manufacturers from operating at the 111 level. While there are a number of ingredient manufacturers who may or may not not meet 111 standards I feel confident the vast majority of the volume of the ingredients supplied to the dietary supplement industry are manufactured in top tier 111 compliant facilities despite the accountability requirement from FDA. What does remain lacking is the transparency to the supply chain when many of these companies do make the commitment to the quality standards ascribed to out of commitment to quality. George Pontiakos is accurate in pointing out the reality that many companies do not correctly recognize the quality standards put forth by the most responsible ingredient manufacturers but through more education and transparency of the differences of manufacturing process that fact will hopefully change.

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