The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

The US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

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. 

FDA asks for nominations for voting or non-voting consumer members of its advisory committees. Also wants to hear from consumer organizations interested in participating in selecting consumer representatives for its advisory committees or panels.

Amid organizational and leadership changes and numerous competing high priorities, the FDA’s planned Notice of Proposed Rulemaking to ban formaldehyde-containing hair-straightening products has been pushed from April to July 2024. An agency spokesperson provided an update on related activities, which are being closely watched by NGOs, state-level policymakers, and industry stakeholders.

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.

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

The European Commission fines International Flavors & Fragrances Inc. and its French division €15.9m after a senior employee deleted WhatsApp messages with a competitor during an inspection, part of an ongoing antitrust investigation into four major flavors and fragrance manufacturers.

Proposition 65 titanium dioxide lawsuits have been halted by a ruling in California in a First Amendment case, which could bode favorably for other scientific challenges to mandated warning labels.

Elixir Cosmetics has reached a $2.3m settlement with US consumers in California state court over alleged violations related to isopropyl cloprostenate use in Babe Lash and Babe Brow offerings. On 5 May, plaintiffs making similar allegations filed suit against the company in New York federal court.

Beauty and personal-care companies should draft an artificial intelligence use policy as soon as possible, regardless of their AI plans, given its ubiquity and the potential for employees to use it on their own, says Melanie Howard, partner at Loeb & Loeb LLP.

The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.