Overlapping federal rules can sometimes create nooks and crannies that the originators didn’t intend. The Council for Responsible Nutrition has identified one such possible loophole in the interplay between the dietary supplement GMP rules (Part 111) and a portion of the Food Safety Modernization Act (FSMA).
FSMA, while primarily aimed at the manufacture and importation of conventional food, does contain some portions directly applicable to dietary supplements. One of those is found within the Foreign Supplier Verification Program (FSVP). This portion lays out the responsibilities of an importer of goods that are also subject to Part 111.
In comments to FDA on the FSVP rule , CRN states: “FDA proposes modified FSVP requirements for dietary supplements and dietary supplement components; these vary depending on whether the importer is bringing in dietary supplements or dietary supplement components for further processing (including packaging and labeling), or finished dietary supplement products. CRN finds the modified FSVP requirements for importers of finished dietary supplements appropriate and recommend the same requirements for importers of dietary supplements for packaging and labeling.”
For CRN, the issue is safety for consumers, and a level playing field for all participants in the market, said Andrea Wong, vice president of regulatory affairs for CRN.
“It’s really important for CRN and our member companies that whenever possible we raise the safety bar,” Wong told NutraIngredients-USA. “Whether foreign or domestic, we want to make sure the products are safe for consumers.”
Under the applicable portion of the GMP rules (Part 111.70(f)), a company that receives a product from a supplier for packaging and labeling as a dietary supplement must “establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order.”
But in the preamble Part 111, FDA says that “a firm that only packages and labels a product may rely on information about the content of the product that itreceives from the manufacturer.”
“We have identified a potential gap for safety,” Wong said. “If you look at very closely at the GMP regulations, especially in the preamble there is a statement that can be interpreted that packagers and labelers can rely solely on the certificate of analysis from the manufacturer. There is no requirement to independently test the products.”
In other words, as CRN sees it, companies that fall into this niche do not have an obligation to verify that the products were made in compliance with GMP standards, as long as they can be reasonably certain that they meet specifications. As matters stand, CRN said in its comments that: “It appears that the only FSVP requirement for firms that import dietary supplement products for packaging and labeling in the United States, beyond maintaining a written list of foreign suppliers, is to set a specification for the product, include it in a purchase order, and review documentation from the supplier to confirm that the product supplied is consistent with the purchase order.”
CRN proposes that the FSVP rules that apply to importers of finished dietary supplements should apply to companies that import a product for labeling and distribution. Under the proposed FSVP rule, companies outside of the packaging and labeling sphere must comply with rules on review of food and supplier compliance status, hazard analysis, supplier verification (except listing of suppliers), investigative and corrective actions, and FSVP reassessment.
CRN proposes that these rules pertaining to supplements remain within FSMA, and that these new requirements pertaining to all companies be cross-referenced with the applicable portions of Part 111.
The goal, Wong said, is to make sure that all of the products on US shelves meet the same requirements.
“For finished dietary supplement products we believe the requirements (within the FSVP) are robust and do assure safety and we want to make sure that for packagers and labelers the same standard applies,” she said.