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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft Compliance Policy Guide entitled “Sec. 555.250 Major Food Allergen Labeling and Cross-contact.” The draft guidance, when finalized, will replace existing guidance for FDA staff on FDA's enforcement policy regarding major food allergen labeling and cross-contact.
Submit either electronic or written comments on the draft guidance by July 17, 2023 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2023-D-1103 for “Sec. 555.250 Major Food Allergen Labeling and Cross-contact.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to Office of Compliance (HFS-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.
Yinqing Ma, Office of Compliance (HFS-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2479, email: Yinqing.ma@fda.hhs.gov; or Denise See, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
We are announcing the availability of a draft Compliance Policy Guide (CPG) entitled “Sec. 555.250 Major Food Allergen Labeling and Cross-contact.” This draft CPG would update and replace existing guidance for FDA staff on FDA's enforcement policy regarding major food allergen labeling and cross-contact. The content of current CPG Sec. 555.250 was written before the enactment of three major laws that are the foundation of FDA's regulatory framework for major food allergens: Food Allergen Labeling and Consumer Protection Act (2004), FDA Food Safety Modernization Act (2011), and the Food Allergy Safety, Treatment, Education and Research Act (2021). The current CPG Sec. 555.250 also does not reflect requirements in our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (now codified at 21 CFR part 117).
We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.
Dated: May 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10523 Filed 5-16-23; 8:45 am]
BILLING CODE 4164-01-P