The American Herbal Products Association (AHPA) submitted comments last week that urge the Food and Drug Administration (FDA) to significantly modify its July 2013 Proposed Rule implementing the Foreign Supplier Verifications Program (FSVP) requirements established by the Food Safety Modernization Act (FSMA). AHPA also urges FDA to not issue final regulatory language until it has redrafted the proposed language and allowed stakeholders to provide feedback on the revised draft.
AHPA's more than 70 pages of comments on the draft FSVP rule expand on AHPA's comments on FDA's proposed "Hazard Analysis and Preventive Controls" Rule and proposed "Produce Safety" Rule. They are aimed at ensuring the final regulations are consistent with the Congressional intent behind FSMA while maximizing flexibility for compliance and eliminating confusion for affected domestic and international businesses. The following summarizes a few of the points from AHPA's comprehensive comments.
Food ingredients also used as drug ingredients should be exempted from food cGMPs
There are many instances when the exact same ingredient can be used to manufacture multiple FDA-regulated classes of goods, including both foods and drugs. There are also many food ingredients that can be used as pharmaceuticals in foreign jurisdictions, but only have food uses in the U.S. These include items such as microcrystalline cellulose USP, folic acid USP and peppermint oil EP.
These ingredients are typically manufactured under stringent cGMPs for pharmaceutical excipients or active pharmaceutical ingredients. AHPA believes that food ingredient compliance with official monographs and pharmaceutical cGMPs fulfills the objectives of FSMA and provides an adequate level of public health protection. Requiring additional compliance with food cGMPs would be superfluous, and AHPA recommends that both the Hazard Analysis and Preventive Controls Rule and the FSVP Rule be modified appropriately.
Food products that are manufactured as natural drug products in a foreign country should be exempted from food cGMPs
Many finished food products imported to the U.S. as dietary supplements are regulated as drug products in the foreign jurisdiction where they were manufactured. This is because the U.S. Congress has recognized that foods are both inherently safe and often crucial to promoting good health. Regulating these food products as "drugs," as is done in some other countries, creates an expensive bureaucratic roadblock that drives up costs and limits consumers' access to the health products they need. Congress has therefore wisely chosen to avoid imposing on natural health-promoting foods the more burdensome requirements that exist in some other countries.
When these food products are manufactured in a country that treats them as "drugs," the product is generally required in the foreign jurisdiction to comply with an official monograph, product registration, or market authorization that sets the required attributes of the product, including limits on harmful contaminants, and to be manufactured pursuant to stringent cGMPs. AHPA believes these requirements fulfill the objectives of FSMA and provide an adequate level of public health protection. Requiring additional compliance with food cGMPs would be superfluous, and AHPA recommends that both the Hazard Analysis and Preventive Controls Rule and the FSVP Rule be modified appropriately.
Exemptions for dietary supplement components and dietary supplements
AHPA strongly supports the establishment of modified FSVP requirements for importers of dietary supplement components. AHPA agrees with FDA that the existing requirements to verify that components meet established specifications provide adequate assurances to protect the public health. AHPA therefore agrees with FDA's proposal to apply modified FSVP requirements to importers of these products. AHPA also strongly supports FDA's proposal to establish modified FSVP requirements for importers of finished retail packaged dietary supplements. FDA appropriately proposes that importers of such products should verify the supplier's compliance with 21 C.F.R. part 111 rather than conduct a hazard analysis.
Small foreign suppliers and certain farmers should be appropriately defined and exempted
AHPA's comments assert that farms growing botanicals other than fresh produce must be excluded from the requirements for foreign suppliers because the supply chains involving non-produce botanicals are typically quite long and complicated. There is normally a long chain of buyers, traders, and brokers between the farmer and the end user, especially for botanicals traded in the international market. As a result, it would be impracticable for FDA to require importers to identify the farm on which the goods were grown, as even the exporter often does not have reliable information about the grower. Furthermore, there is no public health reason for the identity of the farm to be required; there are no regulations that govern the production of botanicals other than fresh produce, and non-produce botanicals are subject to further processing prior to consumption.
AHPA also recommends that the definition of "very small foreign supplier" -- for entities that will be exempt from some regulatory requirements -- be based on the number of employees, rather than the dollar volume of sales. AHPA notes that financial information is considered highly sensitive by most companies (especially those not publicly traded), and small foreign suppliers will likely be reluctant to share this information with importers. Even if they do, importers will have little means to verify the accuracy of the information provided. In addition, using the U.S. dollar value of sales would provide an unfair advantage to foreign firms because many (if not most) foreign suppliers are located in countries with currencies valued much lower than the U.S. dollar.
Modified requirements regarding contamination and hazard analysis
AHPA agrees with FDA that the FSVP Rule should be limited to problems that cause a food safety risk and suggests this guideline should be used consistently throughout the Rule to provide appropriate focus. AHPA notes that not all adulterants cause an actual food safety risk (e.g., Salmonella in a raw agricultural commodity that will be subject to commercial processing with a kill step), and that many forms of adulteration are not amenable to discovery by the importer. A broad range of actions might technically render a food "adulterated" without posing an actual food safety risk (such as minor GMP deviations that do not contaminate the product or otherwise render it unfit for food use).
AHPA further notes that it is not practical for importers of raw materials and ingredients to perform a complete hazard analysis and thereby avoid contamination that will render finished food unsafe. Ingredient importers often have no way to know how their raw materials and ingredients will be used or what effect the purchaser's manufacturing process will have on potential contaminants (e.g., to increase or decrease the levels of contamination). They also cannot control serving size, packaging, storage conditions, or target consumers; which other ingredients at what levels will be combined into that ready-to-eat food; or what the contaminant levels in those other ingredients will be. This severely limits importers' ability to evaluate the presence or severity of hazards.
AHPA recommends that, at least for foods that will be subject to additional processing, FDA permit potential hazards in imported food that are not controlled by the foreign supplier or the importer to be controlled through appropriate disclosure of the potential hazard to prospective buyers in labels or commercial documentation accompanying the food.
Dun & Bradstreet Data Universal Numbering System (DUNS)
AHPA strongly objects to FDA's proposal to require use of DUNS numbers as identification numbers in the import process. For various reasons, FDA should not require use of this for-profit company's services, particularly when FDA has not proposed to contract with Dun & Bradstreet to provide the services in a manner necessary to address AHPA's serious concerns. Accordingly, AHPA proposes several alternative approaches to requiring use of DUNS numbers.
FDA should issue a second draft before publishing a final version
FDA recently announced its intention to revise and accept public comment on certain sections of the draft regulatory language for two other FSMA rulemakings -- "cGMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food" and "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption." In comments on the initial proposals for these rules, AHPA and other stakeholders urged FDA to take an added step by issuing another draft before publishing final rules, and the agency has agreed to do so for certain provisions.
"AHPA views the proposed FSVP Rule as a complex new set of regulations with large and broad economic and cultural consequences," AHPA stated in its comments. "AHPA therefore urges FDA, as we did in our comments to the other two Rules, not to make the next step in the process of this FSVP rulemaking a final Rule, but rather to publish a second set of proposed Rules and invite additional comments specifically on those provisions which are newly-proposed or which changed significantly between the first proposed Rule and the second."