Senate Confirms Dr. Robert Califf as FDA Commissioner
In September 2015, JPA members were notified that President Barack Obama had nominated Dr. Robert Califf to replace Dr. Margaret Hamburg as Commissioner of the Food and Drug Administration (FDA). Dr. Califf recently served as FDA's Deputy Commissioner for Medical Products and Tobacco. According to Reuters, the Senate confirmed Dr. Califf as Commissioner.
FDA Public Meeting on FSMA Import Safety Regulations
The FDA recently issued a Constituent Update announcing a public meeting will be held on March 21, 2016 in College Park, Maryland to “provide importers and other interested persons an opportunity to discuss import safety regulations and programs, including final rules for foreign supplier verification programs for importers of food for humans and animals and accreditation of third-party certification bodies.” The Agency will also provide an update on the status of the Voluntary Qualified Importer Program and answer questions about the import programs.
The meeting will also be accessible via webcast. Refer to the Constituent Update for complete details regarding registration.
FDA Extends Deadline for Comment on "Gluten Free" Labeling of Fermented or Hydrolyzed Foods
JPA earlier notified members that the FDA had issued a Constituent Update announcing the deadline to submit comments on the proposed rule to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed would be extended for 60 days, following publication of the notice in the Federal Register. The Agency recently published the Federal Register notice (81 FR 8869; February 23, 2016) extending the deadline to comment on the proposed rule to April 25, 2016. The deadline to submit comments on the information collection provisions only (Section V. Paperwork Reduction Act of 1995) was February 22, 2016.
FDA Extends Deadline to Comment on Food Additive Petition to Ban Certain Synthetic Flavorings
JPA earlier notified members that the FDA had published a Federal Register notice announcing the receipt of a petition requesting that the Agency amend the food additive regulations (21 Code of Federal Regulations Part 172.515, “Synthetic flavoring substances and adjuvants”) to no longer permit the use of the following seven synthetic flavorings: Benzophenone (also known as diphenylketone), Ethyl acrylate, Eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol), Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene), Pulegone (also known as p-menth-4(8)-en-3-one), Pyridine and Styrene. The petitioners asserted that new data is available, which shows these food additives are carcinogenic and not safe for use in food. The petitioners also requested that the FDA establish a zero tolerance for these flavorings. The FDA established March 4, 2016 as the deadline to comment on the petition.
The FDA recently issued a Federal Register notice (81 FR 8867; February 23, 2016) advising a request to extend the deadline to comment had been received, and the Agency was extending the deadline to May 3, 2016.
National Organic Program 2016 Sunset Review
In March 2015, JPA notified members that the National Organic Standards Board (NOSB) would review substances on the National List of Allowed and Prohibited Substances (the National List) that would sunset (i.e., their use will expire) in 2016. Details regarding the following substances subject to sunset in 2016 were shared with members: Egg white lysozyme, L-Malic Acid, Microorganisms, Activated charcoal, Cyclohexylamine, Diethylaminoethanol, Octadecylamine, Sodium acid pyrophosphate, Tetrasodium pyrophosphate, Peracetic acid, Whole algal flour, Glycerin, Triethyl citrate, Ammonium hydroxide, and Polyalkylene glycol monobutyl ether.
The United States Department of Agriculture (USDA) recently issued a notice in the Federal Register (81 FR 8821; February 23, 2016) to advise that L-Malic Acid, Microorganisms, Activated charcoal, Peracetic acid and Sodium acid pyrophosphate will continue to be listed on the National List in Section 205.605, Nonagricultural (Nonorganic) Substances Allowed as Ingredients in or on Processed Products Labeled as "Organic" or "Made with Organic (Specified Ingredients or Food Group(s))."
JPA members were earlier advised that a proposed rule had been issued in December 2015 to remove Egg white lysozyme, Cyclohexylamine, Diethylaminoethanol, Octadecylamine, and Tetrasodium pyrophosphate from the National List due to a lack of support for the continued use of these substances. According to details posted on the USDA website, available here, the following petitioned substances failed to be added to the National List: Whole algal flour, Triethyl citrate, Ammonium hydroxide, and Polyalkylene glycol monobutyl ether. Glycerin was removed from Section 205.605(b) (synthetic materials for handling) and added to Section 205.606 (Nonorganically Produced Agricultural Products Allowed as Ingredients in or on Processed Products Labeled as "Organic") of the National List.
FDA Publishes Small Entity Compliance Guide for Omega-3 Fatty Acid Claims
The FDA recently published a notice in the Federal Register (81 FR 8833; February 23, 2016) announcing the availability of a Small Entity Compliance Guide to explain the requirements of a final rule pertaining to nutrient content claims for the omega-3 fatty acids: alpha-linolenic acid (ALA), docosahexaenoic acid (DHA) and eicosapentaenoic (EPA), which was issued on April 28, 2014. According to the FDA, the final rule prohibits claims that a food is “high in” DHA or EPA. In addition, claims such as “rich in” or “excellent source of” DHA or EPA are prohibited. The guidance is formatted as “Questions and Answers” and provides insight on the following:
? Submitting a notification for a prospective nutrient content claim
? Types of nutrient content claims prohibited by the rule
? Why nutrient content claims for DHA and EPA are prohibited by the rule
? Why nutrient content claims for ALA based on a population-weighted approach are prohibited
? Which claims for ALA are allowed to remain on the market at this time
The final rule became effective on January 1, 2016.
JPA will continue to monitor and provide updates, as information becomes available.