Legislation

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

CRN suggestion that FDA prioritize facility inspections on firms which haven’t been cleared in third-party audits apparently has support at agency. But FDA hasn’t been receptive to adjusting its policy on precluding from use as dietary ingredients any substance studied or approved as a drug.

Whether Democrat Harris or Republican Trump is in White House or which party has majority in either chamber of Congress, the FDA’s conundrum will continue around a regulatory pathway for allowing use of ingredients derived from hemp in supplements.

Dietary supplement ingredient promising enhanced memory and mental clarity marketed widely across the US has been authorized for sale in Europe.

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.

Congress will be on Capitol Hill briefly after 5 November elections before current session ends. It hasn’t prioritized re-authorizing 2018 farm bill, which de-scheduled hemp as a controlled substance. Until changes come through farm bill re-authorization or other legislation, federal definition of lawful hemp will remain any part of the cannabis plant containing no more than 0.3% concentration of delta-9 THC.

Provision in Wyden and Merkley’s “Cannabinoid Safety and Regulation Act” referencing FDA authority outside hemp-derived ingredients could provide agency with needed authority to force from the market products labeled as supplements but containing drugs or eliminate the use of many safe ingredients in supplements.

Food Standards Agency tells companies marketing caffeine supplements, “It is your responsibility to ensure food supplements you sell are safe for human consumption.”

Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.

Council for Responsible Nutrition contends New Jersey bill, which Assembly Health Committee amended with substantial language to make restrictions more stringent on 23 September, is targeted as inaccurately as restrictions in New York effective in April.

Democrats Wyden and Merkley author Cannabinoid Safety and Regulation Act to limit sales to consumers 21 and older and authorize FDA to order recalls and impose bans on cannabis products with dangerous chemicals or additives. It also would establish regulatory structure for using cannabinoids found naturally in hemp and allowing “semi-synthetic” ingredients while prohibiting artificial or fully synthetic cannabinoids.

Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.

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.

In this installment of HBW Insight’s “Inside Regulatory Affairs” series, Haleon’s regulatory strategist Niels Kildemark welcomes the challenges that the EU Green Deal brings, but warns that meaningful consultation with all stakeholders, including industry, must be prioritized to ensure clarity of regulatory purpose and execution.

Joint letter on scheduling for proceedings before a trial CRN’s attorneys and state AG’s office recently submitted in New York federal court includes, among other information, a statement that both the trade group and the state anticipate a settlement could be reached.

Key challenges facing companies working to implement the European Sustainability Reporting Standards have been identified by the European Financial Reporting Advisory Group. Onur Durmus, Partner at sustainability consultancy ERM, shares his thoughts on EFRAG’s findings and offers takeaways for firms that will be subject to the EU’s Corporate Sustainability Reporting Directive.

California Senate Appropriations Committee suspends consideration of bill for current session after it and Judiciary Committee voted to recommend passing the bill earlier in session. Legislative sessions continue in Massachusetts and New Jersey with bills for similar restrictions.

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.”

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.”