Organic & Natural meets with NY AG, calls to bring raw material manufacturers under 21 CFR Part 111

By Stephen Daniells contact

- Last updated on GMT

"Applying Part 111 [to raw material manufacturers] is necessary to supply chain integrity" - Todd Harrison, president of Organic & Natural
"Applying Part 111 [to raw material manufacturers] is necessary to supply chain integrity" - Todd Harrison, president of Organic & Natural
Organic & Natural Health Association became the first trade association to meet with NY AG’s office this week, and is calling for FDA’s current GMPs (code 21 CFR Part 111) to be applied to raw material manufacturers.

“Our meeting was encouraging as it is clear we have common goals that revolve around ensuring consumers are purchasing products that can be verified for quality ingredients at the earliest possible point in the manufacturing process,”​ said Karen Howard, CEO and executive director of Organic & Natural. 

“There has been an overemphasis on scrutinizing testing methods by the natural products industry when the real issue at hand is elevating transparency to the point that consumers feel fully informed and empowered by their purchase.  This can only be accomplished through honest relationships and full disclosure between companies and consumers.”

21 CFR Part 111

Organic & Natural are proposing that raw material manufacturers are also brought under 21 CFR Part 111 and that the obligations of private-label distributors under those standards are clarified. The association is submitting a citizen petition to the FDA to request an amendment to the current regulation.

“It would make sense to apply the FDA’s current cGMPs (code 21 CFR Part 111) to raw material manufacturers,” ​said Todd Harrison, partner at Venable, LLP, and president of Organic & Natural. “Not only does it provide flexibility but would also be welcomed by branded ingredient manufactures that are already following cGMPs but are forced to compete with lower quality ingredient manufactures that have minimal, if any, cGMPs.”

Talking with NutraIngredients-USA, Howard said: “We realize there will be a mixed response from industry on this, but there is an unleveled playing field.

“If you look wider at ingredients like chondroitin – the level of quality of that ingredient is all over the place: This is not just about herbs, it’s about the integrity of the supply chain for the whole industry.”

“Applying Part 111 is necessary to supply chain integrity,” ​added Harrison.  “We believe it is crucial to transparency and traceability when it comes to herbal and dietary supplements.”  

 ‘Collaboration is better than arguing’

Howard said the organization is very confident in the petition. “We appreciate that FDA is resource strapped, but we are willing to do whatever we can to make this a possibility,”​ she said. The focus for the association is to get the petition submitted by the end of the month.

Organic & Natural, which was formed just eight months ago, is the newest of the trade associations representing stakeholders in the dietary supplements industry (although its remit is wider, and membership extends to businesses involved in the production, distribution or sale of organic and natural food, products or services, as well as consumer and nonprofit organizations). The association has not had formal conversations with the other supplement trade associations on this issue of 21 CFR Part 111, said Howard.

“Our position is collaboration is better than arguing,” ​said Howard. “We are taking a pro-active position. It may be more complex for other organizations, but it doesn’t serve consumers for trade associations to battle against a coalition of attorneys general.”

“We have been asked to continue the dialogue with the AG’s office and we will continue to do that,”​ she added.

Who is currently subject to 21 CFR Part 111?

The Code of Federal Regulations states: 
“Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and

(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.”

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1 comment

...are we forgetting something?

Posted by BP,

FSMA. Food Safety Modernization Act. Anyone over at O&NHA bother to consider that the FSMA proposed rules will be replacing 21 CFR 110 - and therefore there would be no need to move ingredients under 111?

This is not helping anyone but this trade organization that is simply working to make itself important...and that's what we really need - ANOTHER trade group in the supplement space because the 4 that already exist just aren't enough...

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