Compliance

Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”

New Jersey Assembly passed bill amended to expand extensively in defining which products, or ingredients, would be subject to a ban on sales to consumers younger than 18.

In first of two articles from recent interview, president and CEO Steve Mister discusses examples the trade group provides for self-regulation, “where people or companies who might not do it on their own because it would put them at a disadvantage if they were the only ones.”

The Federal Trade Commission’s Consumer Protection head Sam Levine says bipartisan leaders at the state and federal levels are taking on consumer protection issues like never before and using the FTC’s approach as a model for legislation.

Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.

Reorganization creating in Human Foods Program makes the work of additional staff available for dietary supplement office programs. FDA’s “got a little tiny workforce” for “a huge industry,” says Commissioner Robert Califf.

Report from European Commission's Alert and Cooperation Network finds EU consumers are being deceived by companies marketing supplements making unauthorized health claims and containing unapproved ingredients. 

Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.

Dietary supplements containing unauthorized novel foods were reported to the European Commission by national regulators on around 40 occasions in the second quarter of 2024.

As it has every year since FSMA was passed in 2011, FDA doesn’t plan to impose reinspection fees until it publishes guidance for small businesses to request reductions. FY2025 budget proposal includes plan “to re-structure the fee programs to make it more administratively feasible to operate.”

Consumer health, particularly food supplements that make unauthorized medical or health claims, has been a key area of focus for the UK Advertising Standards Authority's recently introduced Active Ad Monitoring system, which captures ads by relevant advertisers from a range of social media platforms, and applies machine learning algorithms to identify and flag likely non-compliant ads, which are then sent to experts to review and act on. This infographic highlights recent ASA rulings against ads for supplements claiming to treat anxiety and stress, menopause, autism/ADHD and weight loss, which were flagged by AI.

Warning letters to SuXiang Medical Instrument in China and Yahon Enterprise in Vietnam among recent warnings FDAS sent to OTC drug and supplement manufacturers, including a Florida firm, White Label Leaf, warned about selling gummies containing delta-8 THC, and other OTC skin care product firms.

Attorneys discuss potential impacts on consumer health products industry from Supreme Court’s “Loper Bright” decision in June on litigation brought by two fisheries, Loper Bright v. Raimondo and Relentless v. Department of Commerce.

Noting similar warnings a year ago, the FDA and FTC announce warnings to six more, part of a joint effort to stop sales of copycat food products containing delta-8 THC, saying companies selling these "illegal products are demonstrating complete neglect for consumer safety.”

Committee’s report published with FY2025 appropriation states a different approach to establishing FDA regulation of non-drug products containing hemp as a derivative of cannabis de-scheduled as controlled substance in the US since 2018.

Analysts suggest more and larger investments than president’s recent $1m and $5m private placements needed to last long enough to establish sales of its functional beverage sufficient to turn a profit. Results expected soon from clinical trials on “detoxifying the alcohol out of” users’ bodies.

CRN gained approval of motion for expedited briefing when it notified Second Circuit it would appeal District Court for Southern New York’s ruling against its motion for preliminary injunction against state law prohibiting sales to minors of supplements and OTC drugs containing ingredients labeled or promoted for weight loss and bodybuilding.

Finished product following Reagan-Udall food safety programs review establishes Human Foods Program in commissioner’s office while also realigning centers, offices and divisions across agency to improve collaboration with regulatory affairs, which conducts facility inspections and other field operations.

Court ruling that state’s restrictions “may very well regulate protected speech”’ allows CRN “to move forward on the merits of the case,” says CEO Steve Mister. CRN’s allegations “plausibly support the inference that the [restriction] might very well regulate protected speech,” judge writes.

Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael Rogers.