Legal

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.

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. 

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.

Whether called “dark patterns,” “shady” online marketing practices, or simply deception on the internet, the issue has taken on high importance at the US Federal Trade Commission and is being tackled by new laws in a growing number of states. Amin Talati Wasserman partner Lauren Aronson discusses in this interview with HBW Insight.

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.

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.

Former DOJ official notes this can be a difficult question before government initiates an investigation unless there is an obvious problem. DOJ official describes benefits of cooperation and how data analytics have changed the way the department identifies and vets cases.

New York law crosses so many federal regulations it would also affect Rx drug sales while allowing consumers to file complaints alleging businesses violate the law, NPA argues in complaint filed in federal court in New York City.

The European Food Safety Authority is evaluating new reproductive and developmental toxicity data published since it paused CBD novel food applications last year due to safety concerns, according to food law consultancy, Legal Foods.

“What are retailers going to do? They're either going to put it behind a case or they're going to put it in a pharmacy-only counter where you have to ask for assistance to get it,” says CRN CEO Steve Mister. “Until we have some more insight, we're being over inclusive in terms of what we're including,” says attorney Claudia Lewis.

Sales of supplements and OTC drugs labeled for weight loss and bodybuilding supplements in New York will be prohibited to consumers younger than 18 starting in April 2024. “Once one state does it, what you see is that other states sort of look at that,” says CRN CEO Steve Mister.

Consent decrees in federal court come four years after FDA warned both Evig and Premium Production about noncompliant claims for Evig’s Balance of Nature brand supplements and GMP violations at Premium’s plant.

The UK Home Office has accepted a suggested 0.05 mg per dose limit for controlled psychoactive substance tetrahydrocannabinol in consumer CBD products, including food supplements. However, remaining questions such as what constitutes a single dose of CBD, when UK manufacturers will be allowed to process raw cannabis, and what testing methods are needed to detect THC levels indicate that the road to compliance is still “long and winding,” argues Canna Consultants.

The UK Food Standards Agency should review its recently published guidance recommending an acceptable daily intake (ADI) of 10mg cannabidiol for consumers, says food law expert Mark Tallon. Data in the public domain, such as that published by Tallon and colleague Robert Child shows that short-term consumption of CBD isolate is safe for adults at circa 100mg per day if applying the FSA’s assessment approach, he explains.

Allowing evidence for “traditional use” could break the regulatory deadlock regarding health claims made for botanical food supplements, the European Commission has suggested. This would unlock innovation currently stunted by the “on hold” situation, note researchers Alie de Boer and Karin Lenssen in a paper for the European Parliamentary Research Services (EPRS). However, there are regulatory issues that would need to be resolved for this to work, they point out.

An Italian administrative court has suspended the recent reclassification of CBD as a narcotic until 24 October, when it will look at the matter more closely. 

In other finding at odds with previous court decisions, federal judge says direct seller Neora doesn’t have an “agency relationship” to its independent sales representatives and isn’t responsible for ad claims they post.

“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.

“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”