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 priorities for over-the-counter homeopathic drug products. Although we will not re-cap the recent history of the industry here so we can keep this post a reasonable length, in late 2016 the Federal Trade Commission (FTC) announced its long-awaited policy for the advertising and marketing of OTC homeopathic drugs (see prior post here). The FTC’s action followed two public workshops convened in 2015 to deliberate a multitude of thorny legal and regulatory issues associated with consumer-directed homeopathy – one hosted by the FTC and the other hosted by the Food and Drug Administration (FDA). Written comments were also collected after both public meetings.

On December 18, 2017, FDA finally released a revised enforcement policy (in draft form) following this robust and comprehensive re-examination of the regulatory framework for homeopathic products. The enforcement policy applies only to human drugs labeled as homeopathic and sold without FDA premarket approval. Continue Reading FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

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 Commission (FTC) held public workshops in 2015 to gather information about this uniquely-regulated class of consumer products.  Today, FTC released an Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs  (available here); a Staff Report on the discussions held during the September 2015 workshop (available here); and an FTC blog post summarizing these actions.

For readers who are not familiar with homeopathy, the practice dates back to the 1700s and posits that disease symptoms can be treated by tiny doses of substances that produce similar symptoms if given in larger doses to healthy people (“like cures like”).  Accordingly, modern-day homeopathic remedies that we find ubiquitously in drug stores today are highly diluted formulations, which some people consider to be no more effective than placebo.  The FTC Staff Report provides an excellent overview of how this OTC industry has grown over the past 50 years and the viewpoints presented by both supporters and skeptics of homeopathy.

 The upshot to the new FTC Enforcement Policy is this:
 “No convincing reasons have been advanced either in the comments or the workshop as to why efficacy and safety claims for OTC homeopathic drugs should not be held to the same truth-in-advertising standards as other products claiming health benefits.”

Continue Reading FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

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 over 400 other adverse event reports over the past six years (since a 2010 consumer alert about certain ingredients in the same products).  The Agency is warning parents and caregivers to seek medical care immediately if an infant or child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels. It is also advising consumers to dispose of any such products they may have in their possession. Continue Reading Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

The Pick Off DefenseIn recent years, we’ve noticed a new maneuver that class-action defense counsel have increasingly added to their playbooks: The Pick Off.  This is how the play is run: Offer the named plaintiff(s) full relief through a Rule 68 offer of judgment and, even if the plaintiff(s) reject the offer, argue that the fact that they were offered full relief nevertheless moots the case and requires dismissal.

For reference, Rule 68 of the Federal Rules of Civil Procedure allows a defendant to “serve on an opposing party an offer to allow judgment on specified terms, with the costs then accrued.”  If the plaintiff rejects the defendant’s Rule 68 offer of judgment and the judgment ultimately obtained by plaintiff “is not more favorable than the unaccepted offer,” then the plaintiff is liable for any costs the defendant incurred after the offer was made.

Continue Reading Class Action Defense Counsel adding ‘The Pick Off’ to Their Playbooks