FDA Reopens Comment Period on Reportable Food Registry ANPR

 

On June 18, FDA reopened the comment period on an advance notice of a proposed rule that would introduce certain changes to the Reportable Food Registry (RFR), implementing provisions in Section 211 of the Food Safety Modernization Act (FSMA).

The RFR reporting requirements apply to all FDA-regulated categories of food and feed, except dietary supplements and infant formula. Reporting requirements apply to registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the Food, Drug and Cosmetic Act.

Currently, registered food facilities, as well as federal, state, and local government officials, may voluntarily use the RFR portal to report information about reportable foods. But the agency proposes to extend requirements to food retailers including new requirements for posting consumer notices in stores.

Under the proposed rule, FDA could require a responsible party to submit “consumer-oriented” information to the agency, so consumers could identify whether they were in possession of a reportable food. FDA would publish a one-page online summary of the consumer-oriented information in a format that grocery store chains could print and post where consumers could view them.

Under the proposal, a grocery store with 15 or more physical locations that sold a reportable food identified in an FDA one-page summary, would be required to prominently display the FDA one-page summary, or the information from the summary, within 24 hours after the one-page summary is published on FDA’s website. The agency said it would especially welcome input concerning:

  • What information responsible parties should be required to provide that would enable consumers to accurately identify the foods,
  • Methods and locations used by grocery stores to provide food recall information to consumers, and
  • Potential impacts and costs to chain grocery stores related to posting consumer notifications.

The purpose of an Advanced Notice of Proposed Rulemaking is to obtain public input on specific issues that will form the basis of the proposed rule. By submitting comments in response to the ANPR, the public can help to shape the proposed- and ultimately the final rule.

Another benefit of an ANPR is that the proposed rule will be more closely aligned with public expectations thus reducing the potential that the agency will have to repropose rules as was the case for several key FSMA regulations including human and animal preventive controls and produce safety rules.

Comments on the ANPR may be submitted online at regulations.gov using docket number FDA-2013-N-0590. The new comment deadline is August 18, 2014.

Why Submit GRAS Notification for a Dietary Ingredient?

A new dietary ingredient (NDI) is a dietary ingredient that was not sold in the United States as a dietary supplement ingredient before October 15, 1994. Manufacturers of NDI-containing dietary supplements must notify FDA of their intent to market a NDI-containing supplement at least 75 days before the supplement is marketed in the U.S. The NDI Notification must thoroughly identify the NDI, how it is used in the NDI-containing supplement, and present the evidence the manufacturer relied upon to determine their use of the NDI in the supplement is reasonably expected to be safe. The NDI Notification requirement applies to every NDI-containing dietary supplement regardless of whether other firms have submitted NDI Notifications on the same substance. There is an exemption to the NDI Notification requirement provided for dietary supplements containing only NDIs that have been used for food in the same chemical form as is being used as a NDI (21 U.S.C. 350b(a)(1)). FDA has codified these requirements at 21 CFR 190.6.

FDA discussed its positions on NDI related issues in a draft guidance. One Q&A in the FDA’s guidance speaks directly to whether a NDI Notification would be required for a NDI that also has a GRAS food ingredient use. FDA noted that a substance legally marketed as a food ingredient in conventional food would be exempt from the NDI notification requirement because it has been present in the food supply as an article used for food in a form in which the food is not chemically altered. Submission of a GRAS Notification will establish a basis for a NDI to be legally marketed as a food ingredient.

The NDI Notification process intended in DSHEA for FDA to have some oversight on dietary supplement manufacturers’ safety assessments of their NDI-containing dietary supplements. However, in some situations it may make more sense to submit a generally recognized as safe (GRAS) Notification for NDIs.

Dietary Ingredients, are defined (21 U.S.C. 321(ff)(1)), include (a) vitamins, (b) minerals, (c) herbs or other botanicals, (d) amino acids, (e) dietary substances for use by man to supplement the diet by increasing the total dietary intake, or (f) concentrates, constituents, extracts, or combinations of the (a) through (e) ingredient categories.

Something such as a new, patented bacteria strain does not qualify as a dietary ingredient because it is not one of the categories named in (a) – (d), nor is it a “dietary substance” (category (e)) because it has never been in the human diet. Thus, FDA is likely to reject a New Dietary Ingredient (NDI) Notification for the new bacteria strain on the basis that the substance is not a dietary ingredient.

Submitting a GRAS Notification for food ingredient applications of the new bacteria strain establishes food ingredient uses for the new bacteria strain. A substance’s GRAS Notification becomes the basis to assert that the substance is a ‘dietary substance for use by man to supplement the diet’ and thus eligible as a dietary ingredient use.

When the substance of interest for dietary ingredient use is NOT clearly in one of the (a) – (e) dietary ingredient categories, then submitting a GRAS Notification will be imperative because there is a great risk that a new dietary ingredient (NDI) Notification would be rejected outright on the basis that the substance does not qualify as a dietary ingredient and thus cannot be a NDI.

Taking the GRAS Notification path allows supplement manufacturers to side-step the need for filing multiple NDI Notifications for each NDI-containing dietary supplement.

Section 413 of the FD&C Act states that a NDI Notification is not required of a dietary supplement containing only dietary ingredients which have been present in the food supply as an article used for food [413(A)(1)].

Submitting a GRAS Notification for food ingredient and dietary ingredient applications of a substance establishes there are recognized uses of the substance “as an article used for food.” Dietary supplements are not subject to the NDI Notification requirement when they contain only dietary ingredients which have been present in the food supply as an article used for food. A substance’s GRAS Notification becomes a basis to assert that the substance is in the food supply as an article used for food and therefore exempt from the NDI Notification requirement.

The NDI Notification requirement applies to each dietary supplement containing a NDI irrespective of how many previous NDI Notifications have been submitted for the same NDI. It would be advantageous for a dietary ingredient supplier to submit a GRAS Notification for a NDI substance (establishing the NDI substance to be in the food supply) and thereby exempting the NDI from the NDI Notification requirement.

Follow up (August 2014)