Policy & Regulation

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 gut’s microbiome will shape future medical advances, offering personalized therapies and prevention strategies for a wide range of diseases.

At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”

Supergut brand owner Uplifting Results Labs makes Gut Healthy GLP-1 Booster prebiotic fiber mix along with its snack bars and meal-replacement shakes available through GNC. IHerb launches supplements addressing side GLP-1 effects including nausea and pain, loss of muscle mass and changing blood sugar levels.

With monographs@FDA portal down, agency moves to NextGen and extends comment period through 27 September for first OTC monograph change it proposed using its overhauled program other than 32 monographs finalizations required in 2020 legislation authorizing overhaul.

OTC sales edged up at Italy's Recordati in the first half of 2024 as higher demand for GI products and supplements offset a weaker cold & flu season.

P&G's FY2024 Q4 net sales were flat at $20.5bn, lower than consensus estimates, but the firm says its underlying business divisions are healthy and forecasts FY2025 sales up 2% to 4%, up 3% to 5% organically.

Legislator education is key to checking state bills that overreach, says Ross, executive VP of government affairs at the Personal Care Products Council, discussing the rising tide of US state bills aimed at restricting ingredient use.

FDA reminds companies which registered with agency solely to manufacture OTC sanitizers during COVID-19 public health emergency they will be subject to FY2025 OTC monograph user fees if they don’t delist and deregister as monograph drug manufacturers by 12 a.m. on 31 December.

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials. 

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.

Ryan Nelson does some testing of Insights' new publishing platform.

The House Appropriations Agriculture, Rural Development, and FDA Subcommittee advanced the FDA’s fiscal year 2025 funding bill, beginning a likely long and difficult budget cycle. 

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.

Where a US hemp product firm stands on whether de-scheduling the botanical as a controlled substance in the 2018 farm bill left a loophole allowing chemically derived and potentially intoxicating cannabinoid strains to qualify could determine whether it agrees with the detour.

The ability to quickly scour the internet for comments on drugs may make it challenging to weed out true adverse events from junk as Senate Republicans consider AI-related changes to FDA's authority.

Ag committee members in 23 May markup likely to broach topic of delta-9 THC limit for hemp. Since hemp was de-scheduled in 2018, cannabinoids other than delta-9 but with psychoactive effects have become leading sales drivers. “Most states now have legal marijuana programs, they just don't know it,” says cannabis industry attorney.

DEA NPRM to move marijuana from CSA Schedule I to Schedule III says synthetically derived THC “is outside the CSA’s definition of marijuana” and “will remain in Schedule I.”  Synthetically derived THC includes copies of ingredients derived from cannabis plants which qualify as hemp by containing no more than 0.3% delta-9 THC concentration by dry weight and are common in supplements and food available in US.

Aimed at curbing so-called "Sephora kids" purchases of anti-aging cosmetic products, a California bill would prohibit sale of skin-care products or cosmetics containing retinol or AHAs to consumers under age 13.

In this episode of the updated Over The Counter podcast, HBW Insight speaks to sustainable packaging expert Tony Perrotta about the complexities of replacing plastic pill packs in medicines packaging. Perrotta is a partner at PA Consulting, which set up the Blister Pack Collective alongside consumer health players Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the Collective hopes to commercialize within 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which hopes to replace plastic bottles in the food, personal care and consumer health industries, will soon launch its first market trial.