FOOD AND DRUG ADMINISTRATION
Does Your Weight Loss Drug Make the Good List?
On Sept. 5, the FDA established a “green list” for imported GLP-1 ingredients. An import alert system has been created to avoid allowing harmful ingredients used in GLP -1 drugs from entering the U.S. market. This green list aims to target compounded versions of GLP-1 drugs created with ingredients not in compliance with FDA standards. ...
Compounded versions are not yet FDA approved and are not reviewed for safety, effectiveness or quality and the FDA has identified some areas of concern for compounded FLP-1 drugs including dosing errors, adverse events, and compounds made using salt forms which are different active ingredients than in the approved medications. The FDA announced it will work with state regulators and take enforcement actions as necessary.
Stopping Sneaky Shrimp Imports
On Sep. 2, the U.S. FDA released results from an investigation conducted from 2022-2024 into short weighting of frozen seafood products. Products from three countries including China, Indonesia, and Vietnam were found to have overstated the net weight of the seafood by including the weight of water glaze and/or ice....
Ten samples of the total 28 collected were found to be in violation and refused entry to the U.S. Those companies found in violation have been placed on an FDA watchlist which allows their products to be detained for inspection. The seafood products at issue include shrimp, prawns, and squid.
Nine Common Chemicals Under Inspection
On Aug. 19, nine chemicals have been added to the FDA’s list of chemicals under review. The FDA says it will be seeking input from stakeholders specifically related to butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), and azodicarbonamide (ADA). These chemicals are used as preservatives and stabilizers in food, packaging, cosmetics, and animal feed. ADA is also used as a conditioner and whitener in dough as well as in the production of foam plastics. ...
The presence of opiate alkaloids on poppy seeds is also being reviewed. Opiate alkaloids are natural components of the coats on poppy seeds and can be present in poppy seeds which are unwashed. In addition, a separate category on the Chemicals Under Review List has been created for lead as a food contact substance separate from lead as a food contaminant.
Updating the list of chemicals under review is part of an FDA plan to modernize and prioritize review of existing chemicals in the American food supply.
Public Hearing on Allergens Set for Late November
A three-day virtual public meeting to discuss food allergens is scheduled for Nov. 18-20. The FDA wants to discuss updated food allergen thresholds for use in labeling and consumer choices. Additional details will be announced by the end of September.
TARIFFS
Tariff’s Continue To Roll Out While The Supreme Court Is About To Rule On Their Legality
Changes To Tariffs On India And China As Well As The Changes To Items Worth Less Than $800)
The Supreme Court will hear an appeal by the White House over the lawfulness of the nearly worldwide tariffs issued by President Trump. The Supreme Court will hear arguments in the case during the first week of November.
On Aug 30, the Federal Circuit upheld a decision of the U.S. Court of International Trade. The Courts have ruled that the 1977 law, the International Emergency Economic Powers Act (IEEPA), which allows Presidents the ability to impose trade policies in time of international crisis, does not grant the power to impose tariffs. ...
The Federal Circuit stayed the reversal of current tariffs to allow the White House time to appeal the ruling. President Donald J. Trump has argued that foreign trade and economic practices have created a national emergency justifying the need for retaliatory tariffs to strengthen the economic position of the United States.
Aug. 27 -Tariffs on India doubled to 50% on Aug. 27.
Nov. 10- The executive order postponing the tariff increase on China expires. Currently the tariff on Chinese-made goods is 30%.
Aug 29 - Goods under $800 in value can no longer enter the U.S. without being subject to the tariff imposed on their nation of origin. On Aug 29, the de minimis exemption was eliminated. This exemption had already been suspended in May for China and Hong Kong but as of August was eliminated worldwide.
CONGRESS
Ensuring Safe and Toxic-Free Foods Act
Introduced July 17, this bill takes aim at reshaping the Generally Accepted as Safe (GRAS) framework . This path currently allows companies to introduce new chemicals or ingredients into products as long as they self-certify the additives under the generally accepted as safe guideline. ...
Secretary of Health and Human Services, Robert F. Kennedy Jr., has announced his desire to close this pathway and now Democratic senators are taking up the cause. The FDA last updated this rule in 2016. In March, Secretary Kennedy directed the FDA to examine the GRAS process and work to eliminate it.
Safer Beauty Bill Package
July 16- Four Democratic Representatives reintroduced a four-bill package to update federal cosmetics laws. These bills would supplement the Modernization of Cosmetics Regulation Act passed in 2022. Critics of that act complain of deadlines missed and non-existent enforcement. Some states have enacted their own regulations to address federal inaction....
The bills, which were originally proposed in 2021, are: the Toxic-Free Beauty Act which bans phthalates and formaldehyde; the Cosmetic Supply Chain Transparency Act, which requires suppliers to disclose ingredients and safety data; the Cosmetic Hazardous Ingredient Right to Know Act which requires labeling and websites to disclose ingredients which pose health risks; and the Cosmetic Safety Protections for Communities of Color and Salon Workers, which would fund research and public education to find safer alternatives to cosmetic products commonly used by women of color.
The next step for these bills is to head into committee for deliberation.
Stop Price Gouging in Grocery Stores
Introduced by Michigan Representative Rashida Tlaib (D) in August, this bill proposes to block technology such as digital price tags, surveillance, and use of facial recognition from being used to customize prices. Thirty-nine states, including Michigan, already have price gouging laws on the books intended to avoid gouging during states of emergency.
STATESIDE NEWS
Where’s the BEEF? Oklahoma joins states to tighten rules on what can be called “meat”
The Oklahoma has been the latest state to adopt a restriction on what can be labeled as meat. Truth in Food Labeling law, signed by Gov. Kevin Stitt in May, requires food manufacturers, distributers, and retailers to clearly disclose that cell-cultivated or cultured products or those that come from a lab, plants or insect proteins are not meat....
In May 2024, Florida became the first state to ban the manufacture and sale of cell cultured meat. Alabama passed a similar ban a few days later. This past July, Iowa began enforcing new labeling requirements on manufactured protein products including labeling requirements for “fabricated-egg products.” The Oklahoma law takes effect November 1.
RELATED LINKS:
FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients
Import Alert 99-47
FDA Update on Post-market Assessment of Chemicals in the Food Supply
List of Select Chemicals in the Food Supply Under FDA Review
FDA Update on Post-market Assessment of Chemicals in the Food Supply
Edited by Maureen Donoghue
MDonoghue@plma.com