Policy & Regulation

Only Opella’s own Enterogermina brand was found by a company-funded study to be contamination-free, to contain the claimed content, and show resistance to all tested antibiotics.

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.

FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.

Self-care solutions such as OTC drugs and wearables can save over 725,000 lives a year, argues a new report published by Reckitt and health insurance firm BUPA.

HBW Insight extracts lessons from six ASA rulings related to ads for prostate dietary supplement and self-test products, all of which fell foul of the regulators AI-powered Active Ad Monitoring system.

Enforcements at facilities in Missouri operated by Shaman Botanicals and Relax Relief Rejuvenate Trading were preceded by administrative detention orders, FDA’s first use of the authority since its reorganization in October 2024.

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.