How FSMA changed the outsourcing industry for dietary supplements

November 14, 2018

Spawned from a spike in the number of foodborne illnesses in the early 2000s, the Food Safety Modernization Act (FSMA) was developed to take a more proactive rather than reactive approach when it comes to food contaminants. Though signed into law in January 2011, implementation continues through 2019 as FDA and food manufacturers alike remodel how they approach food safety practices. While the new rules don’t directly impact dietary supplements—“those areas are already addressed within GMP [Good Manufacturing Practices] requirements,” says Steve Holtby, president and CEO of Soft Gel Technologies Inc. (Los Angeles, CA)—they completely change the landscape of expectations when it comes to dietary ingredients, sending a ripple effect across the entire industry.

Among other regulations, dietary ingredient manufacturers must be sure to use approved suppliers, verify them (and figure out how to do so), ensure that preventative controls are implemented and effective, and document all of it. Plus, the FDA now has recall authority—the ability to mandate that companies recall products deemed unsafe—as well as the ability to conduct inspections to ensure compliance. Finally, and perhaps most notably, FSMA brings with it much tougher standards when it comes to imports, requiring importers to ensure that their foreign suppliers have compliant controls in place. At minimum, FSMA demands on-site audits; without them, FDA can block entry. 

The good news is that everyone knew this was coming and had ample time to prepare. Still, the question remains: is the industry ready? According to Gisele Atkinson, vice president of quality and technical affairs at the Council for Responsible Nutrition (CRN; Washington, DC), approximately 60% of GMP inspections on dietary supplement companies in 2017 resulted in the FDA issuing a Form 483. “And this compliance report is in relation to a regulation that became mandatory 10 years ago,” she says. “FSMA regulations started rolling out seven years ago, with some compliance dates still a few years ahead; and these regulations are much more far reaching than dietary supplement GMPs alone. So we have yet to see the results of FSMA inspections.”

Still, if you ask Atkinson, FSMA is a good step for the dietary supplement and ingredients industry because a rising tide lifts all boats: holding the industry to a higher standard at every step of the supply chain can only increase consumer confidence as bad actors are eliminated from the market. Responsible companies with a strong track record of quality and compliance will likely go beyond what’s required, she says, and will be prepared for the changes. “The industry has been highly anticipating the passage of FSMA, since it now holds the entire business supply chain accountable to higher standards for food safety and prevention,” agrees Holtby. “This is important because the food industry governs our raw material manufacturers and distributors, and now they are held accountable to food safety regulations.”

However, as Atkinson points out, there remain a lot of mid-size and smaller companies with less experience that will “continue to struggle with what is required,” she says. “And, unfortunately, there are still some outliers that ignore the law altogether.” Overall, CRN supports FDA enforcement actions against companies that are non-compliant, says Atkinson, since “FDA needs to get these bad actors to come into compliance or face consequences.”

That doesn’t mean, though, that new challenges in the wake of FSMA passage are limited to the bad actors alone. Even well-meaning and well-prepared companies that prioritize transparency and quality will face a few growing pains as FSMA compliance hits its stride.