Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes...more
In April 2023, the Federal Trade Commission announced a number of consumer protection actions and inquiries involving an important U.S. Supreme Court Ruling regarding the ability of defendants in FTC and SEC actions to raise...more
Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more
In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more
The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction...more
The National Advertising Division (NAD) determined that Avadim Health, Inc., did not provide adequate substantiation for health claims for its Theraworx Relief for Muscle Cramps and Spasm Foam (Theraworx MCS) and Theraworx...more
The Federal Trade Commission (FTC), in its mission to protect consumers from deceptive and unfair commercial practices, has been particularly vigilant during the COVID-19 pandemic because of an expected increase in outright...more
On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
A New Jersey appellate panel reversed dismissal of a false advertising suit challenging claims for a homeopathic flu medicine, allowing the suit to move forward....more
On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. Four of the letters were issued to four companies that jointly manufacture and package...more
On November 8, 2018, the Ninth Circuit affirmed a jury verdict in a consumer class action deceptive advertising case in favor of Defendants Boiron Inc. and Boiron USA, Inc. (together, “Boiron”), the sellers of a homeopathic...more
Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000 products marketed. ...more
On 22 February 2018, the French Health Authority (ANSM) published on its website its "Recommendations to applicants and holders of marketing and registration authorisations" on the names of medicines....more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more
FDA closed out 2017 with a brief, but long-awaited, draft guidance on Drug Products Labeled as Homeopathic (Homeopathic Guidance), which lays out FDA’s new regulatory strategy for these products. Under the Federal Food, Drug,...more
Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more
More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug...more
$30M Judgment for Green Coffee Weight Loss Defendant - An executive behind a green coffee weight loss product scam was hit with a $30 million judgment in a recent Federal Trade Commission action in Florida federal court....more
We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more
Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly...more
Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as...more
On September 12, 2016, Southern District of California Judge Barry Moskowitz granted defendants’ motion to dismiss several of plaintiffs’ claims in the putative class action Hammock v. Nutramarks, Case No. 15cv2056 BTM (NLS)....more
On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more
In a comment filed last Friday, the Federal Trade Commission (FTC) responded to its sister-agency’s request for comments by urging the Food and Drug Administration (FDA) to reconsider how homeopathic drugs are regulated. As...more