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."

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.

Independent and small cosmetic companies may decide to pull their products from the state of Washington due to the 1ppm lead limit imposed by the Toxic-Free Cosmetics Act, says consultant Karen Yarussi, who has managed regulatory affairs for Avon and Burt’s Bees. She cites the cost of testing colorants as a major issue for companies.

California authorities say predominance of retailers licensed to sell hemp are compliant with ban published effective on 3 October through emergency regulation. But hemp industry’s contesting the regulation in state court, arguing state authorities inappropriately used emergency action to change state law on hemp products legislature passed in 2021.

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.