Regulatory Options for Food Ingredients in the U.S.

By EAS Senior Advisor for Food & Color Additive Safety Robert Martin

Before releasing any food ingredient into the market, it is incumbent upon the manufacturer/supplier to ensure that the product is safe for its intended use. Oftentimes, deciding how to approach this can be confusing. Under the Federal Food, Drug, and Cosmetic Act, the manufacturer/supplier has primary responsibility for ensuring that a food ingredient is safe, and FDA has the primary legal responsibility for determining that the ingredient is safe under its intended conditions of use. Since 1958, manufacturers have had several options for determining that an ingredient is safe for use in food. These options are listed in the Table below.

Table I: FDA Recognized Approaches to Food Ingredients

Regulatory Option Regulatory Citation Comments
Food Additive Petitions Direct food additive Secondary direct food additive Indirect food additive 21 CFR 171.1 Today used mainly for direct food additives; most indirect food additives use the FCN route if they qualify; some secondary direct additives may also qualify for the FCN route.
Color Additive Petition 21 CFR 71.1 Required for colors
GRAS Petitions 21 CFR 170.35 May be direct or indirect additive; superseded by GRAS Notice program
GRAS Notice See 62 FR 18938ff; April 17, 1997 Voluntary; in practice since 1997; FDA has received more than 400 GRAS Notices since the inception of this program.
Independent GRAS Determination Section 201(s) of the FD&C Act An option; before undertaking, we suggest discussing this option with EAS.
Threshold of Regulation 21 CFR 170.39 Restricted to indirect additives
Food Contact Notification 21 CFR 170.100 This route is now the main route for seeking approval of indirect additives.
New Dietary Ingredient 21 CFR part 190 In effect since 1994; the Dietary Supplement Health and Education Act (DSHEA) amended the FD&C Act to distinguish dietary ingredients as a special case of food ingredients. Prior to 1994, dietary ingredients were treated as other food ingredients.

In effect since 1994; the Dietary Supplement Health and Education Act (DSHEA) amended the FD&C Act to distinguish dietary ingredients as a special case of food ingredients. Prior to 1994, dietary ingredients were treated as other food ingredients.

Food additives can be classified into four main groups: 1) food additives; 2) color additives; 3) ingredients for which either the FDA or the U. S. Department of Agriculture specifically authorized use prior to 1958, the so-called “Prior Sanctioned Substances”; and, 4) GRAS substances, i.e., substances that are agreed upon as safe by the general scientific community on the basis of scientific evidence or history of use prior to 1958. Only food and color additives require premarket approval.

The manufacturer/supplier should first decide which regulatory options meet the intended use. FDA has issued definitions for these food ingredients to assist in this decision. The definitions below are taken from FDA’s Food Ingredients and Packaging Terms.

Direct food additives are those added to a food for a specific purpose in that food.

Color additives may be any dye, pigment or substance which when added or applied to a food, drug, or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting colors.

GRAS (Generally Recognized as Safe) ingredients are those ingredients that are generally recognized by experts to be safe, based on either an extensive history of use in food prior to 1958, or based on published scientific evidence. The determination that a substance is GRAS is not exclusive to FDA. Scientists outside FDA may also make this determination based on the available evidence. However, manufacturers/suppliers may request that FDA review their determination by submitting a GRAS Notification to FDA for review and concurrence. After completion of its review, if FDA concurs, the agency will issue a “No Questions” letter to the submitter indicating that “FDA has no questions at this time …” regarding the GRAS determination.

Any ingredient used in food is expected to be produced and used consistent with Good Manufacturing Practice (GMP) conditions to ensure its safe use. The responsibility for establishing GMP conditions rests primarily with the manufacturer/supplier. Once in use, it is important that the manufacturer/supplier continue to monitor the use of the product to ensure its use continues to be within safe limits.

FDA has also issued several guidance documents to assist manufacturers/suppliers in their effort to seek approval of their food ingredient(s). These guidance documents are posted on the agency’s website.

Should a manufacturer/supplier wish to add an unregulated ingredient to food, we invite them to contact EAS. EAS has a large network of expert scientists with many different areas of expertise and regulatory experience. Among these are food scientists, chemists, toxicologists, and regulatory experts. For specific expertise not available within the EAS network, we also maintain contact with a large number of outside experts to assist on any project.

On the Proposed Rules for the Safety of Imported Food

One of FDA’s biggest challenges as it rolls out new regulations to implement the Food Safety Modernization Act will be outreach and education so every impacted business will know what’s expected under the new, prevention-based regulatory approach. As part of its outreach efforts, FDA posted a presentation on its website on August 19, titled Proposed Rules to Help Ensure the Safety of Imported Food, in which it describes the elements of the Proposed Regulations for Foreign Supplier Verification Programs (FSVPs) and the Proposed Rule for Accreditation of Third-Party Auditors.

The agency explains that the new, integrated approach to imports will include the FSVP and the voluntary qualified importer program (VQIP). But it will also include mandatory certification, and enhancements to the existing prior notice system. In addition, the agency wants to help build the capacity of foreign governments, and to expand its own foreign offices. And it has other tools at its disposal, such as stronger enforcement authority under FSMA.

As you may know, a key principle of the import-related rules under FSMA is that the importers will be responsible for ensuring that the food they import to the U.S. complies with FDA safety standards. Unless a product has a specific exemption, the importer will be required to develop an FSVP for each food imported, with varying requirements based on the type of product, the category of importer, the hazard of the specific food, and on who will control the hazard. If there is no U.S. owner of the food at the time of entry, the importer is deemed to be the U.S. consignee. And if there is no consignee or U.S. owner at the time of entry, the importer will be the U.S. agent or representative of the foreign owner or consignee.

The proposed requirements for supplier verification are mainly based on who will control the hazards that are reasonably likely to occur.

The agency is attempting to be fair with regard to exemptions and to avoid duplication of effort by companies already covered by other preventive requirements. So, for example, products from facilities subject to FDA’s low acid canned food requirements will be exempt, but only with regard to the microbiological hazards elements of the rule. In addition, the agency proposes modified FSVP requirement for dietary supplements and for dietary supplement components.

For these and for other reasons, I believe the FSVP will be a complex regulation to implement, with many opportunities for confusion of responsibilities and roles. As a former regulator, I have sympathy with the agency as it gets deep into this huge task that will take many years to complete. I encourage you to speak up if you see elements of the proposed rules that will be unduly burdensome and to present FDA with workable regulatory solutions. Now is the opportune time.