Preparing for the Pushback on Dietary Supplements

After years of industry-wide growth and relative lack of government interference, is your company prepared for the coming pushback from regulators and the plaintiffs' bar?

For years, manufacturers, distributors, and suppliers of dietary supplements—reported to be a $30 billion industry—have operated largely outside the auspices of federal regulators and have for the most part avoided the attention of state attorneys general and the plaintiffs’ bar. Recent developments suggest those days may be numbered.

The Food and Drug Administration (FDA) has expressed a heightened interest in dietary supplements, most recently filing suit in federal courts in California and New York against two dietary supplement manufacturers for allegedly failing to properly test their ingredients. In each case, FDA asked the court to halt the manufacture and distribution of the products. In a recent 16-month period alone, FDA reportedly took more than 100 actions against the makers and sellers of dietary supplement.

On a separate front, state attorneys general in Oregon, Washington, and Vermont recently have filed lawsuits against the makers of popular energy supplements, alleging they engaged in deceptive advertising. If large-scale litigation against manufacturers of other products is any guide, other states and private plaintiffs’ attorneys are virtually certain to follow suit.

Indeed, a number of putative class action lawsuits already have been filed across the country against various dietary supplement manufacturers, alleging those manufacturers engaged in deceptive advertising and misleading marketing. Recent data also suggests that personal injury lawsuits against dietary supplement manufacturers and suppliers are being filed with increasing regularity.

So, too, have dietary supplements become a topic de jour in the media. Popular news outlets such as Good Morning America, NPR, HBO, and The New York Times have featured dietary supplements in a negative, even ominous, light. This increased media attention almost certainly portends more frequent and more serious attention from lawmakers and litigants, both public and private.

In the face of these developments, manufacturers, distributors, and sellers of dietary supplements are advised to consider the following:

1. Work with governmental affairs specialists to have a voice in shaping the policies of federal and state governments.
2. Stay abreast of updates in the law, which may come quickly but not be consistent across states.
3. Implement policies to ensure compliance with the laws of every state in which the company is doing business.
4. Take steps to reduce exposure to personal injury and consumer protection lawsuits.
5. Be prepared to defend personal injury and consumer protection lawsuits.

The industry is not without recourse. Time, however, appears to be of the essence. The legal and political landscape is changing rapidly, and proactive companies will be better positioned to anticipate and respond appropriately to legal and political challenges.

Bradley Arant Boult Cummings regularly represents a host of diverse clients from the pharmaceutical and medical device sector. Our clients include multinational and domestic pharmaceutical companies, specialty companies, biotechnology companies, and medical device companies.

The trial attorneys in our life sciences and products liability litigation teams focus their practices on defending drug and medical device manufacturers in individual, mass tort, class action and other complex litigation matters in state and federal courts, from inception through appeal.

Our lawyers are experienced at dealing with the unique legal issues faced by companies in the industry, and we have played a key role in developing and shaping these areas of law around the country.