Policy & Regulation

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.

While no doubt welcome, yet another delay to the EU Deforestation Law and suggestion for another review next year could mean a “never-ending” regulatory exercise that creates uncertainty for manufacturers selling products containing or having been made using materials like palm oil, soya and wood.

Lawmakers in IL, MA and NJ as well as MI consider proposals as firms marketing weight loss and bodybuilding supplements in New York already are subject to first-ever state law limiting sales of products to consumers 18 and older.

Regardless of THC level and even though the US hemp product marketplace is growing, FDA regulations prohibit the botanical’s use as a dietary ingredient or food additive because it’s been studied or approved for use as a drug in the US.

Three-judge Second Circuit panel rejects CRN’s argument that New York General Business Law Section 391-oo, effective since April 2024 as first in US to prohibit sales of certain supplements to consumers under 18, violates First Amendment rights of supplement marketers.

Provision supported by Sen. Mitch McConnell, R-KY, along with House Appropriations Committee chair Andy Harris, R-MD, tightens definition of lawful hemp to exclude any THC derivative from cannabis at more than 0.3% concentration by dry weight and specifically exclude synthetics.

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

The European Commission has added magnesium L-threonate to the list of vitamin and mineral substances which may be used in the manufacture of dietary supplements.

State and territory attorneys general urge congressional leaders to clarify definition of hemp, which they say “bad actors have exploited due to a perceived loophole” of 0.3% delta-9 THC level stated in 2018 farm bill de-scheduling as controlled substances some ingredients extracted from cannabis.

BRS Analytical Services in St. Louis recalled more than 75,000 cases of redness and lubricating eye drops and committed “to permanently cease production of all drugs.”

The US Food and Drug Administration is advocating for the development of new alternative methods while specifying that animal tests are needed for sunscreen UV filters, creating uncertainty about the future of NAMs, say animal rights and industry groups.

“I would suggest that we are much more aligned with the mission of making America healthy than we can get the credit for, which leads me to the matter of why some folks have perceived a disconnect between the MAHA movement and our industry's desires,” says CRN CEO Steve Mister.

Speakers at recent Council for Responsible Nutrition conference noted Trump using executive office authorities to extent no other president has while discussing impact of his tariff-driven trade policies on US industries and complaints challenging his tariff orders the Supreme Court will consider.

Center for Drug Evaluation and Research Director George Tidmarsh emphasizes the reduction, but not necessarily the elimination, of animal tests for UV filters in an FDA Voices post, raising questions about the agency’s intentions.

Regulations likely holding consumer product firms’ attention include the Plastic Pollution Prevention and Packaging Producer Responsibility Act, SB 54, scheduled to become effective by 2027. “Easily the most significant, extended producer responsibility law ever to pass in the world,” says lobbyist

The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.

Thanks to a bureaucracy cutting drive by the Vietnamese government, health businesses operating in the country will benefit from a reduced regulatory burden, accelerated product launches, and lower compliance costs.

A Senate committee is investigating leadership changes at the US Centers for Disease Control and Prevention. While the primary focus is vaccine policy, the first hearing suggested the probe could raise questions about FDA independence.

“The European Commission’s work on harmonizing maximum levels of vitamins and minerals should fully reflect the positive role that food supplements can play in safely and effectively addressing micronutrient gaps,” insists Food Supplements Europe chair Peter Loosen.

Filing references Second Circuit ruling on New York attorney general’s appeal of lower court’s finding that state’s laws on unauthorized practice of law unfairly limited services by nonprofit providing free legal advice to residents facing debt-collection actions.