Industry awaits changes to GMPs

Trade association the Council for Responsible Nutrition (CRN) this week urged the Food and Drug Administration (FDA) to revise its proposal so that dietary supplement GMPs only apply to finished product manufacturers, rather than ingredient suppliers.

Most ingredient companies also supply the food industry and would continue to be covered by the existing food GMPs, argued CRN. Supplement manufacturers are then considered the 'gatekeepers' for product quality.

"For many ingredient suppliers, the bulk of their business is in the conventional food industry with dietary supplements representing a small percentage of business. There is no rationale for requiring them to apply two different sets of GMPs to their manufacturing plants, employees, and processes and our concern is that if they are required to do so, it could negatively affect industry and consumers,"​ said CRN president Annette Dickinson.

The CRN, which submitted an extensive set of comments on the proposal to FDA, said it agrees that new GMPs will be beneficial to consumers and to the industry, "provided the regulations are appropriately modeled after food GMPs, strike the proper balance between adequate control and necessary flexibility, reflect high quality standards currently observed by responsible manufacturers, and are adequately enforced by FDA for both US and foreign product manufacturers, large and small".​

CRN is also concerned that the proposed rule relies on exhaustive end-product testing, and lacks a stronger focus on process controls.

"Quality cannot be tested into a product, but must be built into the product from beginning to end,"​ said Dr Dickinson. "If a company incorporates the right process controls from the beginning and follows them every step of the way, much of the burdensome, exhaustive, expensive end-product testing suggested by FDA becomes redundant and unnecessary."​

CRN says it has provided an outline describing a strong and effective process control system, which includes written procedures for key operations and identity testing for all bulk ingredients at the time they are received.

The American Herbal Products Association (AHPA), has added that testing requirements should not force manufacturers to try to 'test in' quality "with analytical methods that do not exist, but rather are designed in a way that produces the pragmatic effect of ensuring that specifications are met by using scientifically valid methods".​

The association, which submitted numerous modifications and proposed revisions based on the concerns of its members, also said that in-process controls and verified suppliers should be allowed to play the important role that they also play in manufacturing. And testing for possible contaminants must be realistic and consistent with rules now in place in food and drug facilities, it urged.

While noting the group's support of well-designed cGMPs for supplements, including herbs, Michael McGuffin, president of the AHPA, added: "Our comments were addressed to those parts of the agency's proposal that were viewed by the membership as insufficient to reach this goal, or alternatively, as redundant or unnecessary."​

AHPA is also asking FDA to apply the same standard for qualifying personnel in the dietary supplement trade as is now required for food and drug manufacturers.

But specifications for purity should be mandated only when needed to address public health issues, and specifications for quality, strength and composition are only needed to show that products meet their represented claims, it argues in the comments.

AHPA has also included a discussion of errors and misrepresentations that were included in FDA's preamble to the Proposed Rule.

"Now that we are past the hurdle of providing thoughtful comments to FDA's proposal, industry must develop strategies for additional actions related to product quality and consumer perception of quality,"​ added McGuffin, who said that the assocation would discuss such strategies at its upcoming meeting. Input of all AHPA members is being welcomed.

AHPA's comments on the Proposed Rule for dietary supplements cGMP can be accessed on its website​.

CRN's comments can be accessed online​.The association is urging FDA to hold public hearings or workshops, to allow further discussion, before finalizing the rule.