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Organic & Natural file citizen petition to apply GMPs to ingredient suppliers

By Stephen Daniells+

15-May-2015
Last updated on 15-May-2015 at 18:54 GMT2015-05-15T18:54:26Z

Organic & Natural file citizen petition to apply GMPs to ingredient suppliers

The Organic & Natural Health Association has filed a citizen petition with the US Food and Drug Administration to extend the FDA’s current cGMPs (code 21 CFR Part 111) to raw material manufacturers.

The petition, dated May 14, also requests FDA to clarify the regulatory responsibilities of private label distributors under Part 111.

“FDA’s efforts to ensure the quality of dietary supplements in the food supply can only be fully realized by requiring suppliers of dietary ingredients—the building blocks of any finished dietary supplement—to (1) adhere to the Part 111 standards of quality that help ensure authentic and safe finished dietary supplement product and (2) ensure that the products they produce are not adulterated in violation of Section 402 of the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and meet the requirements of Section 403 of the FDCA,” states the petition.

“ONHA [also] believes that Part 111 must clearly state the roles and responsibilities of each person subject to the regulations in order to promote an effective and efficient process to produce quality dietary supplements free of adulteration and misbranding.

“To that end, we request that FDA clarify its position regarding the obligations of private label distributors of dietary supplements, including the extent of obligations to oversee contract manufacturers’ compliance with Part 111, as well as any obligation to conduct finished product testing of the dietary supplement sold under the private labeler’s brand name. This issue has become more acute in recent FDA warning letters to some private labelers.”

Readers can download the full petition here .

Meeting the NY AG’s office

Representatives from ONHA recently became the first trade association to meet with NY AG’s office, a meeting that Karen Howard, CEO and executive director of Organic & Natural, described as “encouraging”.

Speaking with us on April 17, Howard said: “It is clear we [the NY AG’s office and ONHA] 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.

“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

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

“Applying Part 111 is necessary to supply chain integrity,” added Todd Harrison, partner at Venable, LLP, and president of Organic & Natural.  “We believe it is crucial to transparency and traceability when it comes to herbal and dietary supplements.”