FDA Releases Final Serving Size Guidance – The guidance is intended to “help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. The final guidance addresses serving sizes of foods, including single-serving foods and other foods that can reasonably be consumed at one eating occasion and require dual-column labeling. It finalizes a draft guidance issued in November 2018.”
FDA Announces Reopening of Ultrafiltered Milk Comment Period – The FDA reopened the comment period for the “proposed rule that would allow the use of fluid ultrafiltered (UF) milk in the manufacture of certain cheeses and related cheese products. The agency is reopening the comment period to solicit any new information on current industry practices regarding the use of fluid UF milk and fluid UF nonfat milk and on the labeling of UF fluid UF milk and fluid UF nonfat milk when used as ingredients.
FDA Publishes Supplement to 2017 Food Code – According to the FDA, “The update addresses recommendations made by regulatory officials, industry, academia, and consumers at the 2018 Biennial Meeting of the Conference for Food Protection.”
FDA Releases Testing Results for PFAS – The FDA stated that it is “posting results from the second round of testing for 16 types of per- and polyfluoroalkyl substances (PFAS) in foods collected for the Total Diet Study (TDS). These findings, along with the first round of testing results posted in October 2019, will inform our continued work to understand the occurrence of PFAS in the general food supply. TDS foods represent a broad range of foods, including breads, cakes, fruits, dairy, vegetables, meats, poultry, fish, and bottled water, that the average consumer might eat and that were not specifically collected from areas of known environmental PFAS contamination.”
FDA Publishes Effective Date for Soy Leghemoglobin Final Rule – The FDA announced its “notice that the stay of the effective date for the final rule amending the color additive regulations to allow for the safe use of soy leghemoglobin as a color additive in ground beef analogue products (e.g., ‘veggie burgers’) is now lifted. This announcement follows the agency’s review of objections submitted by the Center for Food Safety (CFS), a public advocacy organization. The FDA has concluded that CFS’s objections do not raise genuine and substantial issues of fact and do not provide any substantive evidence that would justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. Therefore, the request for the hearing is denied and the final rule adding the regulation is effective.”
FDA and Drug Enforcement Administration (DEA) Take Action on Illicit THC Vaping Cartridge Sales – The FDA and DEA reported that they “seized 44 websites advertising the sale of illicit vaping cartridges containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. The action, which is part of Operation Vapor Lock, reflects ongoing work by federal, state and local authorities to investigate the supply chain of vaping products associated with recent lung injuries. The online networks, some of which were identified based on interviews with patients and families, were advertising THC vaping cartridges in various brand names alongside pictures and statements about THC levels or other information clearly indicating the items for sale would be considered a controlled substance under federal law. To date, none of the products advertised on the 44 websites have been confirmed to be linked to any cases of lung injury. Nonetheless, the FDA and DEA took action to seize these sites, which were advertising THC vaping products for sale over the internet in clear violation of federal law.”
FDA Announces New Center of Excellence – The Compounding Quality Center of Excellence is “an initiative designed to enhance collaboration among and provide educational programs for outsourcing facilities aimed at improving the overall quality of compounded medicines.” The FDA stated, “The Center of Excellence, supported by a contract awarded by the FDA to Deloitte, will have three main areas of focus: in-person and online education and trainings; a conference to give outsourcing facilities, stakeholders and the agency the opportunity to exchange ideas and best practices; and market research to help inform the agency on key issues faced by outsourcing facilities.”
FDA Comments on Report on Opioid Prescribing Guidelines – The FDA stated, “NASEM [National Academies of Sciences, Engineering, and Medicine] examined existing opioid analgesic prescribing guidelines, identified where there were gaps in evidence and outlined the type of research that will be needed to fill these gaps. NASEM also held a series of meetings and public workshops to engage a broad range of stakeholders who contributed expert knowledge on existing guidelines and provided emerging evidence or identified specific policy issues related to the development and availability of opioid analgesic prescribing guidelines based on their specialties. Moving forward, the FDA will consider the recommendations included in the consensus report as the agency works to implement the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) provision that requires the development of evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain for the relevant therapeutic areas where such guidelines do not exist.”
President Trump Takes Steps on Lowering Drug Prices – The administration “issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the [a]dministration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.”
FDA Publishes Proposed Collection of Information for Unique Device Identification (UDI) System – The FDA proposed an information collection related to the UDI system.
FDA Solicits Feedback on Combination Products – The draft guidance is intended to “discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms (generally the most efficient and effective approach), such as the pre-submission process used in the CDRH [Center for Devices and Radiological Health] and CBER [Center for Biologics Evaluation and Research] and the formal meetings used in the CDER [Center for Drug Evaluation and Research] and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.”
FDA Finalizes Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products – The FDA stated that it “ issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.” The guidance outlines how the FDA plans to utilize its enforcement resources related to deemed tobacco products, including vape. According to the guidance, “Beginning 30 days after issuance of this Final Guidance, FDA intends to prioritize enforcement of the premarket review requirements for certain ENDS products, including against retailers selling such products. Specifically, FDA intends to prioritize enforcement against: (1) Flavored, cartridge-based ENDS products (except for tobacco- or menthol-flavored products); (2) All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and (3) Any ENDS products targeted to, or whose marketing is likely to promote use by, minors.”
Pill Mill Prevention Bill Introduced – Sen. Dianne Feinstein, D-Calif., introduced bipartisan bill S.3070, the Preventing Pill Mills Through Data Sharing Act. The bill would “give the Drug Enforcement Administration (DEA) additional tools to hold drug distributors, manufacturers and pharmacies accountable for identifying, reporting and stopping suspicious orders of controlled substances.” It would extend “the penalties and reporting requirements that currently apply to drug manufacturers and distributors to pharmacies” and require “DEA to provide quarterly reports to manufacturers, distributors and pharmacies in a format and manner that better facilitates the identification of suspicious orders.”
New York Governor Vetoes Pharmacy Benefit Manager (PBM)-Focused Bill – Gov. Andrew Cuomo vetoed S6531. The bill would have required increased transparency from PBMs, including discount reporting and certain disclosures.
Reuters Reports Drug Price Increases in 2020 – Reuters reported that more than 250 drugs have increased prices in 2020.