The US Food and Drug Administration (FDA) today announced the release of two major proposed rules that would affect the importation of food products, including dietary supplements, into the US.

Background

Unlike pharmaceutical, biological and medical device products, all of which must undergo a premarket assessment program to ensure that they are both safe and effective, most dietary supplements are instead regulated as food products and exempt from premarket assessment procedures (though a safety assessment may be required if the supplement utilizes a new dietary ingredient [NDI]).

Outside of good manufacturing practice (GMP) regulations, which are largely similar in concept, this means that supplements are largely beholden to food regulations, including two proposed on 26 July 2013 that are intended to boost the safety of food products being imported into the US.

Supplements under the FSVP

The first of these regulations,Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, would require importers of food products to ensure that those products were produced "in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling," FDA explains in the preamble to the regulation.

The proposed rule notes that for dietary supplement component manufacturers, importers who establish or verify compliance with supplement GMP standards "would not be required to comply with most of the standard foreign safety verification program requirements, including hazard analysis and standard supplier verification activities."

Other importers would have to obtain written assurance that the end customer is complying with GMP requirements if the end customer is required to establish and verify those specifications.

However, "importers of finished dietary supplements would be required to comply with most of the standard FSVP requirements, but they would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier is in compliance with the dietary supplement CGMP regulations, rather than verifying that hazards identified as reasonably likely to occur are being adequately controlled," FDA wrote. The agency said this "modified approach" was dictated by Section 418 of the FD&C Act, which otherwise exempts supplement manufacturing facilities from many hazard analysis requirements.

The verification process, the rule continues, will require the use of a "qualified individual" to perform analysis on the product. The term "qualified" is left somewhat undefined, but is taken to mean a person who has completed training in a given area or has sufficient on-the-job experience to develop and implement a food safety system.

In addition, any importer that discovers that food products in its possession were not manufactured in compliance with good manufacturing practices (i.e. the product is adulterated under the FD&C Act) must "take action in response to this noncompliance," FDA wrote. While this action will depend on the circumstances, it could include discontinuing use of the supplier, and should include documenting any corrective actions taken. Importers are also charged with investigating whether the manufacturer's FSVP is adequate under Section 418 of the FD&C Act.

"Records that concern the actual performance of supplier verification activities, relate to complaints, investigations, and corrective actions associated with particular foods, or involve the documentation of FSVP reassessments" should be retained for at least two years, or in some cases for two years after the product's use has been discontinued.

FDA further notes that it is looking for feedback on whether its modified approach is appropriate, or if not, what should be done instead.

New Auditing Process

The second proposed rule, Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, also applies to dietary supplements, and is meant to establish more of the details associated with the use of accredited third-party auditors and certification bodies that form the backbone of the first proposed rule.

"Having comprehensive oversight of a credible and reliable program for third-party audits and certifications of foreign food facilities will help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the US food supply," FDA wrote. "We believe that a trusted program for foreign food safety audits and food and facility certifications-with clear requirements, standards, and procedures and operated under government oversight-will be appealing to accreditation bodies, auditors/certification bodies, and foreign food facilities."

The agency added that it believed the rule could benefit industry by reducing the number of redundant food safety audits, ultimately saving money while increasing trust in the audits that had been conducted.

Under the proposed system, FDA would recognize auditing organizations, which would then audit foreign food (including dietary supplement) facilities and issue certifications. In "limited circumstances," FDA said it would also allow some organizations to become directly accredited, allowing them to accredit other auditors and certification bodies on its behalf.

As a food product, dietary supplements would be covered under this auditing process.

Both rules are being promulgated under the Food Safety Modernization Act (FSMA) of 2011.

Federal Register: Third-Party Auditing

Federal Register: FSVP