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. Medical review of the data and other
information remains ongoing, and no definitive causal link between
the products and the adverse events or deaths has been
Following the FDA warning on September 30th, CVS Health announced that it was voluntarily removing all
homeopathic teething products from its retail pharmacy stores.
Other retailers, such as Walgreen's, are reportedly considering
whether to take actions as well or have already done so. In
addition, the manufacturer with the largest market share of these
products, Hyland's, released a statement on October 11th regarding its
decision to stop distributing them in the U.S. in response to
In its September 30th press release, the Agency explained:
"Homeopathic teething tablets and gels have not been evaluated
or approved by the FDA for safety or efficacy. The agency is also
not aware of any proven health benefit of the products, which are
labeled to relieve teething symptoms in children."
Although the regulatory history and status of homeopathic drugs
is too lengthy and complex for a short blog post, the nutshell
version is that such products have not been subjected to FDA's
review and approval process for new drugs (and thus generally have
not been demonstrated to be safe and effective under FDA's
standards either for prescription or OTC drugs). But as
"drugs" under the Federal Food, Drug, and Cosmetic Act,
they are required to be manufactured in compliance with current
good manufacturing rules for drugs and to be labeled in compliance
with the Act. Among other labeling mandates, this means that
homeopathic products cannot be labeled in a way that is false or
misleading. But without clear standards for these products, whether
particular claims are actually false, misleading, or
unsubstantiated is a topic of much debate between affected
stakeholders, and little agreement.
In 2015, both FDA and the Federal Trade Commission (FTC) held
public meetings about the current regulatory status for homeopathic
products. FDA's public hearing took place in April 2015 and was focused on how the products
get to market and how FDA oversees them. The FTC's workshop on
homeopathic advertising and promotion took place a few months later
in September. Given the high degree of interest
from regulators, and the recent safety concerns with the specific
category of teething-related products, homeopathic drug
manufacturers should be on alert that significant changes may be
coming to their industry – whether in 2017 or beyond.
Private-labelers as well as retailers of such products may also
want to keep track of this area in order to effectively protect
their businesses and customers, as CVS Pharmacy did immediately
after the FDA announcement was made.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Litigation involving claims of unfair or deceptive business practices under Chapter 93A of the Massachusetts General Laws is constantly evolving, and these claims remain a favourite for the plaintiffs' bar...
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).