AHPA Urges FDA to Evaluate Financial Burdens before Imposing FSMA Re-inspection Fees on Small Businesses

The American Herbal Products Association (AHPA; Silver Spring, MD) has submitted comments to FDA regarding provisions of the Food Safety Modernization Act (FSMA) that allow FDA to impose a fee on companies if FDA inspectors need to re-inspect a company’s facilities. AHPA is urging that no FSMA-associated fees be imposed on small business, with the possible exception of those related to failure to comply with a recall order, until FDA publishes guidance outlining the burden of such fees on small businesses.

FSMA currently requires FDA to assess fees for both domestic and foreign facility re-inspections, failure to comply with a recall order, and importer re-inspections. Fees for the current (2012) fiscal year are $224/hour domestically and $335/hour for foreign facilities. (The per-hour rate includes time FDA inspectors spend at a facility during a re-inspection.)

AHPA adds that the guidance it is requesting, detailing burdens on small businesses, is required by law-and may result in reduced fees for small businesses.

“AHPA is concerned that FDA appears to already be assessing FSMA re-inspection fees on small business,” stated AHPA president Michael McGuffin in a press release. “Even though FDA is not yet sending invoices, Congress clearly intended to make sure that the impact of this law on smaller companies was well understood in advance of creating any burden. FDA should delay its fee assessments until the mandated guidance is finalized.”

AHPA adds that one area of relevance of the new FSMA fees to the dietary supplement industry is that FDA may now assess fees for any re-inspection under the current cGMPs for dietary supplements. If FDA conducts an inspection and records “inspectional observations” on a Form 483, it may start to assess these fees when it returns to the facility to determine whether its observations have been adequately addressed. Fees may also be assessed in relation to import-related activities, such as requests for reconditioning of an import initially subject to an import hold.

View AHPA’s full comments.