GNC settles NY AG challenge by pledging to implement stricter supplement controls.

  • As covered in prior posts, New York’s Attorney General (AG) has been investigating the marketing of allegedly misbranded herbal supplements.  The investigation began with the NY AG’s issuance of cease-and-desist letters to four major retailers — GNC, Target, Walmart, and Walgreens — alleging that herbal supplements sold in their stores did not contain the ingredients represented on the product labels.  The AG’s action was based on test results obtained via DNA bar coding, a method intended to detect genetic markers of the products’ botanical sources.
  • Major retailer GNC has announced a settlement agreement with the NY AG’s office.  Under the terms of the agreement, GNC commits to implement “source material traceability standards” across its product lines using DNA bar coding to confirm the authenticity of herbal/botanical ingredients.  The Company also commits to sourcing ingredients from GMP-compliant facilities certified by third parties (e.g., ISO, USP, NSF), to implementing allergen testing protocols in its supply chain, and to labeling all ingredients (including excipients) present in its products.  Further, GNC pledges to provide customer-facing materials (in-store and Internet-based) explaining the differences between whole herbs and extracts and detailing GNC’s extraction methods.  The Company also will provide semi-annual reports to the NY AG’s office related to compliance with specific provisions of the settlement agreement.
  • Aside from the precedent-setting implications of GNC’s settlement in this case, the agreement raises questions about the protective value of FDA compliance in the dietary supplement industry.  As stated in the settlement agreement, the NY AG’s office found no evidence that GNC deviated from federal good manufacturing practices (GMPs) related to dietary supplements.  Rather, the NY AG’s office calls into question the “sufficiency of federal rules and testing requirements and their relationship to state consumer protections [sic] laws.”  The agreement cites critically FDA’s failure to mandate the use of DNA-based technologies, such as bar coding, to authenticate herbal supplements.  The agreement also criticizes FDA’s allegedly inadequate purity standards under the GMP regulations, particularly with respect to the Agency’s tolerance for allergen cross-contact.  One wonders whether NY’s actions and this settlement will mark the beginning of a dual-track regulatory system for the dietary supplement industry.  In the future, it could be that FDA compliance will set merely the baseline for compliance, while state consumer protection standards will set higher — and potentially conflicting or inconsistent — standards for manufacturers and retailers to meet across the nation.