Consultant Marion Boardley has gathered and analyzed statistics on FDA inspections for a number of years. Many of her reports have focused on what this data has to say about compliance in the dietary supplement industry.
FSMA now applies to supplement ingredient suppliers
Dietary supplements are covered under FDA Part 111, which defines Good Manufacturing Practice (GMPs) for the manufacturing, packaging, labeling or holding of dietary supplements. When the supplement GMPs were put into place, ingredient suppliers were exempted from these specific requirements, though they did have to comply with basic food GMPs, or FDA Part 110.
The Food Safety and Modernization Act (FSMA, or FDA Part 117) is meant to supplant Part 110. It applies to dietary ingredient suppliers as well as straight food facilities, so while companies that are already complying with part 111 are exempt from FSMA, there is broad overlap with the dietary supplement industry even so.
With the gradual rollout of the regulation, part 110 is now for the most part history. Boardley said in the most recent data release from FDA, citations under Part 117 account for almost all of the observations (called 483s after the relevant citation in the regulations) under 117 account for almost all of those detailed on inspection reports, with just a few 110 citations left over. Last year, the 483s detailed under each regulation were split about half and half.
Thick stack of FSVP observations
FDA began issuing 483s under Part 117 in 2017, and the proportion of 483s has increased steadily since. When gathering the information together for the history of FSMA inspection, Boardley found that companies are struggling with the implementation of one of the FSMA rules, the Foreign Supplier Verification Program, or FSVP.
Boardley found that 1,204 total 483 citations have been issued that bear on some aspect of FSVP. Under the program, ingredient suppliers (and other domestic food facilities) are supposed to conduct a hazard analysis on their raw materials and ingredients and develop a plan to control for these hazards. Under FSVP, importers of food or dietary ingredients are supposed to do the same for their foreign suppliers. The overall intent of FSMA was to control for food hazards at the point of origin, rather than trying to fix problems once raw materials or finished goods have been imported.
“You have to develop a plan, and what kind of plan depends on where the ingredient is coming from,” Boardley told NutraIngredients-USA.
First warning letter on FSVP
Boardley said a watershed moment came just yesterday, with the first warning letter being issued relating to FSVP, as opposed to the 483 observations mentioned above. FDA issued the warning to a Florida importer of tahini that had been manufactured in Israel. The tahini had been implicated in a salmonella outbreak. If the Florida company does not comply satisfactorily within 15 days, FDA can use a new authority under FSMA to interdict its shipments at the border.
Ways to comply without buying a plane ticket
Larisa Pavlick, head of regulatory and compliance for the United Natural Products Alliance, said FSVP implementation will be a complex undertaking for many companies.
“I think the challenge has been that many companies were not understanding the requirements for preventive controls. And then FSVP is asking them to apply those preventive controls to their foreign suppliers,” she said.
Pavlick said that many smaller companies will not have the travel budget to physically verify how a hazard analysis and preventive control plan has been implemented by their foreign suppliers. There are ways around that conundrum, but they require documentation and statistical validity, she said.
“The inspection does not have to be physically on site. But you have to be able to prove you have evaluated the supplier. You or your supplier has to have a preventive control in place. Oral tradition and handshake agreements (as in, saying you’ve done business with a supplier for years and have never had a problem) are not good enough. They were never really good enough, and now they are really not good enough,” she said.