FDA Misses The Mark Estimating Time and Resources Supplement Industry Spends on Regulatory Compliance
April 20, 2017
WASHINGTON, D.C. – The Food and Drug Administration’s (FDA) request for comment today vastly understates the amount of time and resources the supplement industry spends annually complying with government regulations, including current good manufacturing practices (cGMPs). The FDA today released a request for comment regarding Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
“The supplement industry spends up to $1 billion each year complying with federal regulations,” said Dan Fabricant, NPA CEO and President. “FDA’s record keeping 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.”
Because FDA can request GMP record-keeping documents during a part 111 inspection, they must estimate the burden to industry for requesting these documents every few years through public notice and comment. Similar to their NDI notification burden to industry, FDA underestimates the supplement industry’s time and resources spent complying to the dietary supplement regulations.
For example, the burdens do not estimate all record keeping requirements for any manufacturer of glandular products made from cattle. The Bovine Spongiform Encephalopathy regulation under 21 CFR 189.5 requires firms to keep and maintain health records on cattle from the genus Bos and track the age of all cattle parts used in the manufacture of finished products.
FDA’s record keeping analysis fails to include record keeping requirements for adverse events and serious adverse events related to dietary supplements. NPA also believes the hourly estimates provided by FDA for part 111 record keeping are vastly under-rated. Furthermore, many companies have moved to electronic record keeping and storage, and FDA’s estimates do not consider all of the costs, storage, system controls, and security burdens on industry for complying with part 11, Electronic Records.
The dietary supplement industry spends up to $1 billion each year on compliance, based on estimates and research conducted by NPA:
- Total Estimated Cost to the Industry for Regulatory Compliance: $512M – $1B.
- Total Estimated Cost for FDA Regulation of Industry: $24.5M.
- Dietary Supplement GMPs (2007 Effective with 3 year phase-in for large, medium, and small firms) Annual Cost for cGMPs (according to FDA) is $164M-$190M/year.
- Labeling (1990 Effective Date)
Total Cost to Dietary Supplement Industry in making a labeling change from FDA’s Nutrition Facts Labeling Final Rule (one time) $143M-460M (for relabeling based upon changes in FDA’s labeling)
$204-$357M/year = Cost of labeling or relabeling for the 85,000 estimated dietary supplement product SKUs out on the market (85,000 has been quoted by FDA)
- Adverse Event Reporting (June 2007 Effective Date)
50,000 annual adverse events/year projected for the industry and 1,460 Domestic DS Firms (25,000 hours/year by an individual with medical knowledge)
$50/hr for someone with medical training x 25,000 hr = $1.25M Annually
For more information, visit www.NPAinfo.org