The FDA posted clarifying FAQs for stakeholders for the FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF).

LAAF establishes a laboratory accreditation program for the testing of food in certain circumstances. Under the LAAF program, FDA will recognize accreditation bodies that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories).

These FAQs provide examples of the testing covered by the LAAF final rule; information on the directed food laboratory order, a new tool being implemented in the LAAF rule; and a reminder that LAAF-accredited laboratories are not required to provide FDA with results of tests that are not covered by the LAAF final rule.

Additional Information:

FSMA Final Rule on Laboratory Accreditation for Analyses of Foods (LAAF)

FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods

The US Food and Drug Administration (FDA) issued responses to two food additive petitions and a citizen petition requesting agency action on phthalates in food contact applications. They also issued a request for information about available safety data and current use information of certain phthalates in food contact applications. While there was some overlap among the phthalates that were addressed by all three petitions, they evaluated and responded to each petition individually after having assessed the distinct requests made in each petition, the information included in each petition, and other available information related to phthalates in food packaging and food contact applications.

Their Responses to Recent Petitions about Phthalates in Food Packaging and Food Contact Applications

The FDA amended its food additive regulations to no longer provide for most phthalates to be used in food contact applications because these uses have been abandoned by industry. The FDA revoked authorizations for the food contact use of 23 phthalates and two other substances used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides. The agency is taking this action in response to a food additive petition from the Flexible Vinyl Alliance, filed on July 3, 2018, requesting the agency remove food contact uses for these 25 substances. The petitioners demonstrated that the uses of the 25 substances have been abandoned by industry. This action removes these phthalates from the list of substances authorized by our regulations in 21 CFR parts 175 through 178.

This action also results in limiting the use of phthalates in food contact applications to nine phthalates – eight authorized for use as plasticizers and one authorized for use as a monomer. To better understand the current use of these remaining phthalates, they have requested information on the current specific food contact uses, use levels, dietary exposure, and safety data for the eight phthalates authorized for use as plasticizers. The request for information does not address the phthalate authorized for use as a monomer since any exposure resulting from this use is expected to be negligible.

The FDA denied a separate food additive petition filed by several public interest groups that requested the FDA revoke its food additive regulations to no longer provide for the food contact use of 28 phthalates. This food additive petition proposed to group all 28 phthalates as a single class and remove the listings for those phthalates from the FDA’s food additive regulations based on alleged safety concerns for the proposed class. The FDA determined that the petition does not support grouping the 28 phthalates into a single class, and that the petition also did not demonstrate the proposed class of phthalates is no longer safe for the approved food additive uses. The FDA’s Federal Register Notice includes their response to the assertions included in the petition. Granting the Flexible Vinyl Alliance food additive petition based on abandonment resulted in removing food additive authorizations for 23 of the 28 phthalates addressed by the public interest groups’ food additive petition.

The FDA also denied a related citizen petition by the same public interest groups which requested a ban on the food contact use for certain phthalates and revocation of the prior sanctioned authorization of other phthalates based on alleged safety concerns that were described in their food additive petition. The FDA denied this citizen petition because the petition did not demonstrate through scientific data or information that these actions are warranted.

They Seek Current Data About Phthalate Use and Safety in Food Contact Applications

The FDA issued request for information seeking available use and safety information on the remaining phthalates authorized for use as plasticizers in food contact applications. The FDA is generally aware of updated toxicological and use information on phthalates that is publicly available. Nevertheless, stakeholders may have access to information that is not always made public.

The FDA is seeking scientific data and information on the specific current food contact uses, use levels, dietary exposure, and safety data for the remaining eight phthalates that are still authorized for use as plasticizers in food contact applications after today’s action on the food additive petition based on abandonment. They may use this information to update the dietary exposure estimates and safety assessments for the permitted food contact uses of phthalates.

Submit Comments

Comments about the request for information should be submitted by July 19, 2022, to Regulations.gov and identified with the docket number FDA-2022-N-0571.

For Additional Information:

Final Rule: Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers (Docket No. FDA-2018-F-3757)

Federal Register Notice: Natural Resources Defense Council, et al.; Denial of Food Additive Petition; Denial Without Prejudice of Food Additive Petition (Docket No. FDA-2016-F-1253)

Federal Register Notice: Ortho-phthalates for Food Contact Use; Request for Information (Docket No. FDA-2022-N-0571)

Response to Citizen Petition (found in Docket No. FDA-2016-P-1171)

Phthalates in Food Packaging and Food Contact Applications

News from AAFC’s Market Access Secretariat

On March 22, 2022, the Government of Argentina approved Regulation Nº 27.642 (Promoción de la Alimentación Saludable), in which detailed specifications for the inclusion of octagon-shaped warning labels are required on the front of package of food and beverage products that exceed established limits for salt, sugar, saturated fat, and trans-fat.

Please be aware that the use of stickers to comply with the front-of-package nutrition warning label will be permitted until October 22, 2024. However, after this transitory period is over, all local and imported food and beverage products that exceed the limits set in the regulation will then be required to have printed warning labels directly on their packaging. More information on the labelling requirements and limits can be found in Decree 151/2022 and its annexes (Spanish only).

Exporters are encouraged to contact their importers or local partners to ensure that their products continue to meet all labelling requirements established by the Argentinian authorities. The Embassy of Canada in Argentina can also assist exporters in finding local packaging companies to comply with these regulations, where appropriate.

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry.

The final rule for Accredited Third-Party Certification was issued in 2015 under the FDA Food Safety Modernization Act (FSMA). The rule establishes a voluntary program, known as the Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP), in which the FDA recognizes accreditation bodies that have the responsibility of accrediting third-party certification bodies. The accredited third-party certification bodies conduct food safety audits and certify that eligible foreign food entities and food produced by such entities, meet the applicable food safety requirements of the Federal Food, Drug, and Cosmetic Act and FDA regulations. An eligible entity is a foreign entity in the U.S. import food supply chain that undergoes a food safety audit conducted by an accredited certification body under the Accredited Third-Party Certification Program.

The draft guidance, when finalized, will provide answers to frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program, and is intended to assist accreditation bodies’, third-party certification bodies’, and eligible entities’ understanding of the regulation and program requirements.

Comments can be submitted in writing or electronically within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments at Regulations.gov, using Docket No. FDA-2022-D-0370.

Additional information:

Federal Register Notice

Accredited Third-Party Certification Program

Apply to become an Accreditation Body (Select “Create New Account” and then select the appropriate box under FSMA)

Accreditation Body Electronic Portal User Instructions

Certification Body Electronic Portal User Instructions

Key Facts About the Program

Public Registry of Recognized Accreditation Bodies

Public Registry of Accredited Third-Party Certification Bodies

User Fees

The US Food and Drug Administration (FDA) is announcing the availability of a draft guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). The draft guidance, when finalized, will explain their intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

As they discussed in a recent response to two citizen petitions, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food. However, they have not yet reached a final decision on one petitioner’s request to issue a regulation to permit the use of NAC in dietary supplements, and they are considering initiating rule-making to provide by regulation that NAC is not excluded from the definition of dietary supplement. If, among other considerations, the FDA does not identify safety-related concerns as they continue their review of the available data and information, they are likely to propose a rule providing that NAC is not excluded from the definition of dietary supplement.

While their full safety review of NAC remains ongoing, their initial review has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement. In addition, NAC-containing products represented as dietary supplements have been sold in the United States for over 30 years and consumers continue to seek access to such products. Accordingly, while the FDA continues its evaluation of the request to initiate rulemaking, the FDA issued this draft guidance to explain their policy regarding products labeled as dietary supplements that contain NAC.

Unless they identify safety-related concerns during their ongoing review, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: they complete notice-and-comment rule-making to allow the use of NAC in or as a dietary supplement (if they move forward with such proceedings) or they deny the citizen petition’s request for rule-making. If the FDA determines that this enforcement discretion policy is no longer appropriate, they will notify stakeholders by withdrawing or revising the guidance.

To Submit Comments

To ensure comments about this draft guidance are considered before the FDA begins work on the final guidance, please submit written or electronic comments within 30 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. You may submit electronic comments to Regulations.gov using Docket No. FDA-2022-D-0490.

If you are unable to submit comments online, please mail written comments to:
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s Docket No. FDA-2022-D-0490.

For More Information

Draft Guidance for Industry: Policy Regarding N-acetyl-L-cysteine

Federal Register Notice

FDA Issues Response to Two Citizen Petitions on NAC in Dietary Supplements

Dietary Supplements