Legislation

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.

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.

The Independent Beauty Association says the towering demands posed by new, diverse legislation and regulations – especially at the US state level – have led it to partner with a consultancy that specializes in policy and global intelligence to provide industry-critical insights to the organization and help track bills.

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.

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.

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.

Litigation the court agreed to accept for its term beginning in October doesn’t allege CBD in a tincture purchased in 2012 contained an unlawful level of delta-9 THC but contained any THC at all. Also, FDA Commissioner Califf encourages Congress to authorize regulatory pathway for lawful use of CBD and other hemp ingredients in supplements and food.

Exclusion from procurement processes, confiscation of revenues, and a fine of at least 4% of annual turnover are some of the penalties the European Parliament is considering for greenwashing as part of its position on the EU Green Claims Directive.