FDA Issues Proposed Rule on Importation of Prescription Drugs from Canada
The rule may be found here. Draft guidance on importation of Canadian drugs may be found here.
FDA Releases Supplement to 2017 Food Code
The Supplement modifies the 2017 Food Code to, among other things:
- Allow food establishments in limited circumstances, such as in a restricted office building or break room, that pose minimal risk of causing, or contributing to foodborne illness to operate without a person in charge, as approved by the regulatory authority.
- Add a new exception for when “time without temperature control” is used as the public health control for ready-to-eat produce and hermetically sealed food upon cutting, chopping or opening of the hermetically sealed container. This exception allows these foods to begin at 70°F or less and remain at 70°F for a maximum of 4 hours.
- Remove the allowance for use of chemically treated towelettes for hand washing because the means to wash hands in limited situations is readily available and hand washing has been determined to be effective.
FDA Releases Final Guidance on Nutrition Labeling
Changes from the draft guidance include:
- Providing additional background information in response to a question regarding reference amounts customarily consumed (RACCs) for non-juice beverages for infants and young children (question B.9)
- Modifying for clarity a question and response concerning whether the Nutrition Facts label for products sold in small packages (e.g., certain sugar-free chewing gums) must list all nutrients that are contained in insignificant amounts (question D.2)
- Modifying the response to a question regarding the placement of the Nutrition Facts and Supplement Facts labels to clarify that the Nutrition Facts or Supplement Facts label should not be placed on the bottom of packages (such as the bottom of boxes, cans, and bottles), unless they are visible during normal retail display and consumer handling (question D.4)
The final guidance is available here.
FDA Issues Draft Guidance for the Submission of Plans for Cigarette Packages, Advertisements
The guidance may be found here.
FDA Reopens Comment Period on Use of Ultrafiltered Milk in Certain Cheeses
The proposed rule
, which was issued on Oct. 19, 2005, would amend the definitions of “milk” and “nonfat milk” for cheeses and related cheese products in FDA’s regulations on food standards (often referred to as standards of identity). In 2017, FDA issued guidance to industry indicating that it is exercising enforcement discretion regarding the use and ingredient labeling of fluid UF milk and fluid UF nonfat milk in the manufacture of standardized cheeses and related cheese products while it considers rulemaking. FDA has seen the marketplace evolve and believes it is appropriate to give interested persons another opportunity to comment on the issues raised by the rulemaking. More information may be found here
APHIS Adds Burma and Serbia to List of Regions Affected by African Swine Fever
FSIS Publishes Updated Version of its Guideline on Documentation Needed to Support Animal-Raising Claims
More information here.
Reps Neal and Blumenauer Request ITC Investigation on Illegal Fishing
The letter making the request may be found here.
FDA Finalizes Enforcement Policy on Unauthorized Flavored E-Cigarettes That Appeal to Children
FDA will focus on cartridge-based fruit flavored vaping devices and not mint or menthol products. The policy is available here.
FSIS Responds to Petitions on Free Range, Antibiotic Free Claims and Safe Handling Labeling
FSIS denied a petition on mandatory disclosure of the use of antibiotics in animals. The agency addressed some of the issues brought up in the free range claim petition in a recent rulemaking and continues to consider outstanding issues related to free range claims. FSIS denied a petition to allow voluntary use of safe handling instructions on protective coverings of meat products. More information here.
FDA to Hold Public Meeting on Modernizing Data Collection Strategy
The meeting will be held on March 27, 2020. More information here.
FDA, USDA and EPA Announce Joint Platform to Streamline Information About Agricultural Biotechnology Products
FDA, USDA and EPA have launched a Unified Website for Biotechnology Regulation. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.
CBP Trade Symposium to Be Held in March in Anaheim
The meeting will be held March 10-11, 2020 at the Hilton Anaheim. Register here.
U.S. Codex Committee on Food Additives to Hold Public Meeting
The U.S Codex Office is sponsoring a public meeting on January 21, 2020. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 52nd Session of the Codex Committee on Food Additives (CCFA) of the Codex Alimentarius Commission, in Lanzhou, China, March 2-6, 2020. More information here.
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