The interim final rule, titled “Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients,”¹ was published on June 25, 2007, along with the final GMP rule.² The interim rule would allow manufacturers to submit a petition to the FDA to request an exemption from the 100% ingredient testing requirements of the GMP rule, providing that the manufacturer could set forth the scientific rationale why testing less than 100% of a specific ingredient from a specific supplier would not result in reduced assurance of identity or quality.¹ The public was given until October 24, 2007, to comment on this interim final rule, which represents an extension from the original comment deadline of September 24, 2007.

The Council for Responsible Nutrition (CRN), a leading trade association primarily representing large and medium-sized producers of dietary ingredients and dietary supplement products, recommended that the interim provision be stricken entirely from the GMP rule, arguing that the interim provision “weakens the overall system of process controls otherwise required for dietary supplements and potentially undermines a key safeguard to the assurance of product quality.”³ According to CRN, the costs of the petition process are substantial, meaning that there is little, if any, economic incentive for a company to pursue an exemption. Moreover, the exemption process increases the possibility of errors, and many of CRN’s member companies recently indicated in a CRN survey that they would not consider pursuing an exemption. According to CRN, if the interim provision is accepted into the final GMP rule, then more participation from ingredient suppliers should be allowed or required within each manufacturer’s petition process, presumably in recognition of the expertise that the suppliers have regarding their respective dietary ingredients as well as the close and cooperative relationships that many ingredient suppliers enjoy with some of their long-time manufacturer customers. CRN suggested that the use of a Dietary Ingredient Master File could help accomplish this.

The American Herbal Products Association (AHPA), the leading trade association in the United States dealing with herbal products, submitted comments expressing the organization’s support for the interim final rule and its intended flexibility for manufacturers, but AHPA suggested several modifications to the interim provision.⁴ AHPA suggested that FDA give suppliers of dietary ingredients the opportunity to submit petitions for exemption that would be applicable to customers of those ingredients—particularly since suppliers of botanical ingredients are often in the best position to assure ingredient identity (i.e., as the ingredients would be in their crude, raw form, prior to being powdered, extracted, or blended). AHPA further suggested some minimum supporting data that a manufacturer or supplier should submit in a petition for exemption. The organization recommended that the FDA begin accepting petitions prior to companies’ GMP compliance dates,* that the FDA establish deadlines by which the agency would have to respond to petitions, that FDA consider other models for addressing exemption requests rather than a citizen’s petition, that the FDA reconsider the requirement of statistical analyses in support of exemption requests, and that the agency commit to issuing a guidance document on this regulation as a priority.

The Natural Products Association (NPA), an association representing retailers, manufacturers, wholesalers, and distributors of natural foods, dietary supplements, and health/beauty products, expressed in its comments that it agrees with the intent of the interim final rule but that the exemption should be specific to the dietary ingredient supplier, dietary supplement manufacturer, and to the incoming raw dietary ingredient.⁵ The organization commented that any guidance regarding the interim rule should include a consistent definition and goal of identity testing, as well as a discussion of the minimum ingredient identity characteristics and parameters that should be addressed and monitored in the petition process, the degree of variability in these areas that is acceptable, and the systems that should be used to determine the variability. NPA further stated that an FDA-issued guidance document should describe the minimum requirements needed for a petition, provide detailed criteria for qualifying dietary ingredient manufacturers and suppliers, and address the factors that would cause an ingredient supplier to be unsuitable for the reduced identity testing petition process. NPA noted that it would like FDA to consider specific operational models that would inherently make the petition process more applicable in drafting the guidance and potentially more favorable for using a petition to reduce identity testing, such as a model wherein a supplier produces only one ingredient. NPA asked that the FDA recognize that the statistical and risk expertise needed by dietary supplement manufacturers for developing petitions could entail expenses not previously considered by FDA. The organization further asked whether the agency envisioned a way by which small companies might be able to develop a verification testing plan using the successful petition of a larger supplier if the manufacturer does not receive the necessary minimum number of lots required for developing a verification plan. Like AHPA, NPA also asked that FDA elaborate on the deadlines it anticipates for responding to exemption petitions.