Preventive Control Proposal Creates Dual Regs For Some Nutritionals

The proposed Preventive Controls for Human Food rule under FSMA would impose redundant regulations that could have “deep, resonating effects” on some supplement firms, particularly since most are “without a staff of hundreds” to work on compliance, says food attorney William McConagha.

FDA’s proposed rule for preventive controls required by the Food Safety Modernization Act would create redundant requirements for products manufactured under the dietary supplement good manufacturing practices rule but marketed as conventional food products.

The proposed Preventive Controls for Human Food rule FDA published in January would impose regulations that could have “deep, resonating effects” on some supplement firms, particularly since most are “without a staff of hundreds” to work on compliance, says food and drug attorney William McConagha.

During a panel discussion Feb. 7 at the Food and Drug Law Institute’s Food Week in Washington, McConagha said the proposed rule stirred a sense in industry that it will create duplicate requirements for some nutritional products manufactured by firms that already comply with supplement GMP requirements.

McConagha and other stakeholders said FDA should clarify these issues and prevent regulatory redundancy as it develops the rule and accompanying guidance.

Under the proposed PC rule, domestic and foreign firms that manufacture, process, pack or store food would need written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures, record results and specify actions to correct problems.

Products that are manufactured under supplement GMPs, but marketed as conventional foods could be subject to redundant regulations if the proposed rule goes through.

McConagha, a partner at Sidley Austin in Washington, cited meal-replacement bars and nutritional powders as products that may be manufactured under supplement GMP regulations but are sometimes marketed as conventional food products.

“Do firms need to now comply with two different sets of requirements? Or if you … comply with preventive control, that would be compliant with GMPs? One of the useful things with this is that it is proposed, so hopefully FDA will clarify the relationship,” he said.

The Council for Responsible Nutrition also suggests FDA clarify the proposed rule. The trade group’s comments on the rule will point out the potential for redundant regulations for some products.

Duffy MacKay, VP of scientific and regulatory affairs, said when products manufactured under supplement GMPs are marketed as foods, they are “theoretically” exempt from food GMP compliance. However, under the FSMA’s preventive control proposed rule, they would appear to in fact be subject to food GMPs, he said in an interview.

MacKay said the proposed PC rule requirements resemble supplement GMP principles, but are stated differently. “So there may be facilities running into dual requirements. It’ll be a headache if there is no streamlining,” he said. The relationship likely will be spelled out through guidance.

Additional Concerns

A “huge concern to industry,” McConagha said, is whether the PC rule would require a food firm to review supply chain and production systems and develop prevention controls for each type of product it manufactures, similar to FDA’s quality system requirements for medical device firms.

“The question is to what degree will these be a review of systems in place to identify problems and address them, or something else like QSRs … and doing scientific analytic work that one associates with QSRs,” he said.

FDA directs firms to establish requirements for each type or family of devices they manufacture in order to ensure the devices are safe and effective and to establish methods and procedures to design, produce and distribute devices that meet QSRs.

Compliance with a rule similar to the medical device QSRs, which impose tighter regulation and are more detail-specific than the proposed PC rule, would be difficult for food firms, McConagha said. “I don’t know if that’s a bad thing for public health, but it’s a complicated thing for industry to do.”

Attorney Martin Hahn, the panel moderator, asserted that the proposed PC rule will set the industry up for failure, especially if FDA looks for validation of supplier activities beyond firms’ common use of certificates of analysis.

“I don’t think a certificate of analysis is considered appropriate validation. So it begs the question of, ‘have you validated the preventive control of that system?’” said Hahn, a partner at Hogan Lovells in Washington.

McConagha said supplier validation would be an “ambitious requirement” and FDA would have to state exactly how an importer would conduct the process. Without clear rules, “the more difficult it is for any one supplier to reasonably assess in any kind of validation process exactly what the suppliers are doing and how they could comply with the rules,” he said.

Although firms are concerned about redundant requirements imposed through FSMA regulations, Michael Landa, director of FDA’s Center for Food Safety and Applied Nutrition, said his sense is that food firms complying with the existing hazard analysis and risk-based preventive control requirements will not need additional preventive control requirements. “There is a notion that Congress thought of these as similar paradigms,” Landa said.

He said that most companies already have food safety plans in place, and the PC requirements should not be a substantial change.

Landa added that “FDA is understaffed. … So, the idea of government swooping in and saying your validation system isn’t checking, in my dream world that would happen. But in the real world, that is not happening.”