FSMA is reaching its final stages of compliance, and contract manufacturers are finding a few challenges in its wake.
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.
When it comes to outsourcing, the impacts of FSMA are widespread and, regardless of size, companies are bound to run into some challenges.
First, there is a huge amount of responsibility placed on the shoulders of ingredient manufacturers to verify and document their raw materials and ingredients, which didn’t exist in the past. Ingredient suppliers must evaluate hazards, develop written analysis, create and validate (and monitor) preventative controls, and take corrective action if any missteps are discovered. This evaluation needs to happen at every step of the supply chain, from receiving raw materials through processing, packaging, and storing. And it applies to suppliers worldwide. “The Foreign Supplier Verification rule stipulates that the same preventative safety standards apply to food and supplements consumed in the U.S. regardless of where they are produced,” explains Robin C. Koon, executive vice president at Best Formulations (City of Industry, CA). This complicates matters for contract manufacturers who source ingredients from overseas, especially since “the majority of raw materials in the dietary supplement industry come from overseas,” he says. As a result, Koon expects “more possible delays and potential price increases in receiving material shipments from overseas, due to suppliers needing to be compliant with FSMA.”
Indeed, Soft Gel Technologies, a softgel contract manufacturer, has seen both raw material costs and lead times increase, which impacts productivity and profitability. “We’ve also discovered that it is too risky to do business with smaller companies who offer unique ingredients and reasonable minimum order quantities,” adds Holtby, since they’re often unable to comply with the new regulations. As a result, the quality assurance and regulatory department at Soft Gel Technologies has requested that the purchasing and product development groups eliminate several previously approved suppliers “to help prevent delays with securing certain raw materials in a timely manner,” says Holtby.
When it comes to compliance, rising costs will also come into play for suppliers who don’t do in-house testing, says Frank Cantone, president of ABH Pharma Inc. (Brentwood, NY), since the new regulations require stringent documentation. Hiring third-party labs, of course, adds another line item to the budget. Plus, additional challenges exist for manufacturers who source from suppliers that don’t provide sources for the raw materials they sell. “This lack of transparency is problematic, as it creates a compliance issue for the receiving facility who must establish and implement a written supplier verification program,” says Holtby. This is not a problem at Soft Gel Technologies, he notes, as the company must know the origin of all raw materials used and have supporting documentation from the manufacturers and distributors demonstrating compliance.
Another challenge plaguing the industry overall as this transition enters its final stages is that dietary supplement brands aren’t as educated on the nuances of FSMA since it doesn’t impact them directly, says Atkinson. But this isn’t entirely true. “Supplement manufacturers are exempt from some parts of FSMA but there are significant sections like the Foreign Supplier Verification Program and the International Adulteration Rule that fully apply as new requirements,” she adds.
Brand awareness is a challenge that Koon has also faced. “They need to ensure their supply chain is compliant, so as to not cause an interruption of products,” she says. “Currently, most brands are not really aware of FSMA and its potential effects.”
The good news is that, as Cantone explains, the industry is generally “very prepared from a compliance standpoint.” Not ready? Never fear, says Atkinson, as the FDA has stated it will educate as it regulates. “If companies are showing effort toward compliance, FDA is willing to help educate to help get you all the way there,” she says. “But, if you are ignoring the new FSMA regulations, FDA will be sure to give warning letters.”
In the end, Atkinson thinks the investment and challenges will be worth it, as “there will be overall savings as the food industry shifts to a proactive food safety system and not a reactive one.” The result will be increased confidence in the supplement industry as better-quality products are verified and documented at every step in the supply chain. Is there a more worthy effort?