Many companies give little thought to the Food and Drug Modernization Act (FSMA) even though the implementing regulations most certainly affect the dietary ingredient supply chain. Many ingredient suppliers thought they were saved when FDA specifically exempted them from Part 111, however, FSMA has provided an opportunity to rectify this decision and it appears the agency is going to make the most of the opportunity.

On Sep. 29, FDA proposed amendments to the proposed rules. While these amendments do not rewrite the rules in question, they contain key changes to various provisions. Here we provide a summary of key revisions and discussion of any mention of dietary supplements along with the impact these adjustments may have on manufacturers and distributors of finished dietary supplements and dietary supplement ingredients. 

I. Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food 

Summary of Key Revisions
1. Product Testing, Environmental Monitoring, Supplier Controls

While the potential provisions discussed here were referenced in the preamble of the January 2013 proposed rule, they were not included in the regulatory text. FDA is now providing an opportunity for input on specific language and seeking comment on whether to include it in the final rule.

Specifically, FDA is seeking comment on whether the preventive controls for human food should require:

• “A facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct product testing to verify implementation and effectiveness of preventive controls.”
• “A facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct environmental monitoring to verify implementation and effectiveness of preventive controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard.”

Additionally, supplier controls are proposed when the receiving facility’s hazard analysis identifies a “significant hazard for a raw material or ingredient,” and that hazard is controlled before the facility receives the raw material or ingredient from a supplier.

• If these provisions were to be included, FDA takes the position that the facility would have flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing) unless there is “reasonable probability” that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA).
• In that instance, an annual onsite audit of the supplier would be required, unless the facility can show that “other verification activities” and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled.

2. Additional Proposed Amendments

Small Business Defined: A “very small business” would be defined as firms having less than $1 million in total annual sales of human food, adjusted for inflation.  Previously, three options were proposed: annual sales of $250,000, $500,000 and $1 million.

Withdrawal of Qualified Exemptions Process Further Clarified: The proposed revisions would establish procedures to guide FDA in withdrawing an exemption for a qualified facility for food safety reasons as specified in the proposed regulation. FDA first may “consider alternatives to protect public health” and would provide advance notification to the facility and an opportunity for the facility to respond. The revisions also provide procedures for reinstating a withdrawn exemption and require FDA to provide an additional 60 days (for a total of 120 days) after the receipt of the order for a facility whose exemption is withdrawn to comply with the full requirements for hazard analysis and risk-based preventive controls.

Impact on Dietary Supplements
The preventive controls proposed rule specifically exempts manufacturers of finished dietary supplements; however, it does not clearly exempt manufacturers of “dietary ingredients.” Accordingly, dietary ingredient suppliers and manufacturers are likely to be subject to FSMA’s preventive controls rule.

FDA’s proposed language regarding supplier verification and product identity testing could impose significantly more obligations on ensuring the safety and quality of dietary ingredients manufactured domestically as well as in foreign countries. It is also unclear at this point what FDA would consider “appropriate verification activities” for the purposes of supplier controls. FDA is accepting comments on the proposed revisions until Dec. 15. (The comment period opened Sep. 29.) The agency is only seeking comments (ending Dec. 15) on the amendments and not all the provisions of the original proposed rule.

II. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans & Animals

Summary of Key Revisions
Revisions to the initial proposed rule center around three topics: 1) changes to the hazard analysis and compliance status provisions; 2) revisions to required supplier verification activities; and 3) revisions aimed at ensuring consistency between the FSVP rule and proposed rules relating to preventive controls for human and animal food.

1. Hazard Analysis & Compliance Status Review

The revisions pertaining to hazard analysis are aimed at broadening the scope of the hazard analysis of food contained in the original proposed rule. To do this, the amendments combine the proposed requirement that an importer conduct a compliance status review of each food to be imported and each foreign supplier being considered, with the proposed requirement that an importer analyze the hazards of each food. FDA has also expanded the factors that must be considered in this new comprehensive hazard analysis. In the revisions, FDA provides the following specific list of factors that must be considered:

• The nature of hazards in food;
• The entity that will be applying hazard controls, such as the foreign supplier or the foreign supplier’s ingredient supplier;
• The foreign supplier’s procedures, processes and practices related to food safety;
• Applicable U.S. food safety regulations and information regarding foreign supplier’s compliance with those regulations; and
• The foreign supplier’s food-safety performance history.

In addition to this list, FDA is requesting input on whether a requirement that importers consider hazards that may be intentionally introduced for purposes of economic gain should be added to the list of factors that must be considered as part of the hazard analysis.

In addition to providing greater specification of factors that must be considered, the revisions replace the previously proposed requirement to analyze hazards that are “reasonably likely to occur” with a proposed requirement to analyze “known or reasonably foreseeable” hazards to determine if they are significant (i.e., necessitate control measures).

2. Supplier Verification

The original proposed rule presented two options relating to required supplier verification activities. The revisions depart from both of these originally proposed options and instead propose a hybrid requirement.

Under the hybrid requirements, importers have flexibility to conduct the supplier verification activities that they have determined—based on their evaluation of food and foreign supplier risks—can provide adequate assurance that their supplier is producing the food in a manner consistent with U.S. food safety requirements.

In addition, foods that are associated with a SAHCODHA hazard, the revised standards require initial and subsequent annual onsite auditing of foreign suppliers, unless the importer determines—based on its risk evaluation of the food and foreign supplier—that other verification activities were appropriate and adequate. 

3. Consistency Provisions

To maintain consistency between the FSVP proposed rule and the proposed rules on preventive controls for human and animal food, FDA made the following amendments to the FSVP proposed rule:

• Changing definitions of “very small importer” and “very small foreign supplier” to have no more than $1 million in annual food sales;
• Deeming importers that operate food facilities in compliance with any potential supplier verification provisions that may be included in the preventive controls rules are in compliance with any parallel FSVP requirements to avoid duplicative regulations.

Impact on Dietary Supplements
These revisions to the proposed rules contain a number of changes that specifically apply to dietary supplements. The purpose of the revisions specific to the FSVP requirements for importers of dietary supplements (proposed 21 CFR 1.511), are to reflect the general revisions that were made to the FSVP proposed rule. The amendments are as follows:

1. Revisions to 1.511(a) and (b)

Section 1.511(a) and (b) will be revised to specify that importers of dietary supplements and supplement components subject to certain cGMP regulations in 21 CFR Part 111 (or whose customers are subject to those regulations) would not be required to comply with revised section 1.506(a)—which applies to the requirement to establish and follow written procedures to ensure the use of approved suppliers, replacing the previously proposed requirement to maintain a written list of foreign suppliers.

FDA states this change is appropriate because these importers would not be required to conduct risk evaluations, which provide the basis for supplier approval. FDA requests comment on whether some other requirement concerning identification of foreign suppliers would be appropriate for these importers, such as a requirement (as originally proposed) to maintain a list of the foreign suppliers of dietary supplements and supplement components they import.

2. Revisions to 1.511(c)

FDA is also proposing several revisions to 1.511(c) regarding importers of dietary supplements that will not be further processed.

First, 1.511(c)(1) will now specify that although importers of “finished” dietary supplements are not required to analyze the hazards in the dietary supplements they import, they would be required to evaluate other food safety risks set forth in 1.505(a). Section 1.505(a) contains a list of factors that must be considered when an importer is considering the appropriate supplier verification activities to conduct, as well as a requirement that the importer document its evaluation of the risk.

Second, 1.511(c)(2) is revised to clarify that importers of finished dietary supplements are required to establish and follow written procedures to ensure that foods are imported only from approved suppliers (except in the limited circumstances when unapproved suppliers may be used), instead of maintaining a list of its foreign suppliers.

Third, 1.511(c)(4) has been revised to specify that the purpose of supplier verification activities with respect to finished dietary supplements is to provide assurances that the supplier is producing the dietary supplement in accordance with processes and procedures that provide the same level of public health protection as those required under 21 CFR Part 111.

Fourth, 1.511(c)(5)(i) through (c)(5)(iv) is revised to include requirements for documentation of foreign supplier verification activities by importers of finished dietary supplements.        

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Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.

Sarah Abramson is an associate in Venable’s Regulatory Practice Group where she assists clients with a variety of regulatory compliance and enforcement matters. Her practice focuses mainly on U.S. Food and Drug Administration (FDA) and advertising laws and regulations.