Legal

Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.

Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.

Supreme Court’s Loper Bright “decision is central to this case,” says Jonathan Emord, attorney representing Alliance for Natural Health USA and Meditrend Inc. in a complaint filed in US District Court for the District of Columbia.

Filed on 20 August by Pensacola, FL-based law firm Aylstock, Witkin, Kreis & Overholtz (AWKO) on behalf of an unnamed client, the petition points to benzene study data unconnected to Valisure on unheated benzoyl peroxide products, but is light on details of how it was conducted.

Report from European Commission's Alert and Cooperation Network finds EU consumers are being deceived by companies marketing supplements making unauthorized health claims and containing unapproved ingredients. 

HBW Insight presents a new series profiling regulatory affairs specialists working in or supporting the consumer health and cosmetics industries. In this first installment, we speak to AESGP's Christelle Anquez-Traxler and Oliver Hartmann, senior regulatory science & strategy lead, and regulatory & legal affairs director respectively. 

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

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 unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

Exergen seeks a declaration from Massachusetts federal court that claims challenged by Baxter in the National Advertising Division forum regarding the accuracy of its thermometers do not constitute false or misleading advertising, if they are even advertising at all.

Benzoyl peroxide-based acne drug products and their alleged proclivity to become contaminated with carcinogenic benzene are at the center of putative class actions filing against L’Oreal in federal courts around the US.

J&J, Target and Walgreens face class action complaints in California federal courts for economic harms caused by their sale of benzoyl peroxide-containing acne treatments, following Valisure’s 5 March citizen petition to the US FDA on findings of high levels of benzene in such products.

Habitually noncompliant companies are laughing at FDA, Peter Barton Hutt says.

BBB National Programs found FTC’s proposed Trade Regulation Rule on the Use of Consumer Reviews and Testimonials largely effective with some certainty on whether product reviews or customer testimonials are violations of its false advertising standards. But it =expects some clarifications may come in final rule.

Attorneys are watching how the Federal Trade Commission and other authorities address online marketing practices this year that are increasingly viewed as potentially harmful to consumers.

Plaintiff Marceann Dunning says she and other consumers would not have purchased Supergoop Unseen Sunscreen for body and face, or would have paid less for them, had they known the products’ SPF was significantly lower than the SPF 40 labeled. A rash of similar class actions years back against major sunscreen brands fizzled, ostensibly in quiet settlements with lead plaintiffs.

Wolfe is lauded by former colleagues for his fierceness in pushing to get dangerous drugs off the market, his rigorous scientific approach, and mastery of the press.

Reporting requirements in the EU, California, and likely soon at the US Securities and Exchange Commission will have companies probing deeper in their value chains for sustainability information and attempting to calculate Scope 3 greenhouse gas emissions with limited resources, potentially with unfavorable implications for smaller businesses, industry advocates say.

Preemption not discussed in ruling dismissing plaintiff experts’ testimony other than to note court previously rejected Kenvue’s motion to dismiss based on a preemption argument.

Ruling in federal court in New York approves Kenvue attorneys’ motion to dismiss five experts’ testimony that prenatal use of Tylenol or other acetaminophen oral products linked to autism and/or attention-deficit hyperactivity disorder in children. Ruling likely will lead to dismissal of complaint.