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FDA’s latest request for comment regarding Current Good Manufacturing Practices in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, released April 19, “vastly understates” the industry's expenditure, says an NPA press release.
The Natural Products Association (NPA; Washington, DC) estimates that the dietary supplement industry spends up to $1 billion each year complying with federal Food and Drug Administration (FDA) regulations. Yet FDA’s latest request for comment regarding Current Good Manufacturing Practices in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, released April 19, “vastly understates” that expenditure, says an NPA press release.
As FDA is allowed to request a manufacturer’s GMP recordkeeping documents during the course of a GMP inspection (as of 21 CFR Part 111), the agency is also required by law to share its estimates of the cost burden that those requests pose on industry through its public notice and comment process. However, says Dan Fabricant, NPA's CEO and president, in the press release, “FDA’s recordkeeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately.”
NPA charges that FDA’s analysis fails to include the cost of maintaining required records for adverse events and serious adverse events related to dietary supplements. It also believes FDA’s hourly estimates related to 21 CFR Part 111 recordkeeping requirements are “vastly” underrated. Moreover, the shift that many firms are making toward electronic recordkeeping and storage has incurred considerable costs that, NPA claims, FDA has failed to consider.
Based on its own estimates and research, NPA calculates the supplement industry’s annual compliance costs as follows: