After years of industry-wide growth and relative lack of oversight, are you prepared for the coming pushback from regulators and the plaintiffs' bar?

Storm clouds are on the horizon. For years, manufacturers, distributors, and merchants of dietary supplements have operated outside the auspices of federal regulators and have largely avoided the attention of state attorneys general and the plaintiffs’ bar. Recent developments suggest those days are numbered.

Attorneys general in Oregon, Washington, and Vermont have recently sued the makers of popular energy supplements, alleging they engaged in deceptive advertising. If cases against manufacturers in the past are any guide, other states are almost certain to follow suit.

On a separate front, the Food and Drug Administration (FDA) is also cracking down on the manufacturers and suppliers of dietary supplements. FDA has filed suit in the federal courts in California and New York against two different dietary supplement manufacturers for failing to properly test their ingredients. In both cases, FDA asked the court to stop the companies from manufacturing and distributing their products. It has been reported that in a recent 16-month period alone, FDA took more than 100 actions against dietary supplement companies.

The plaintiffs’ bar has found its way into the mix. A number of putative class action lawsuits have been filed against various dietary supplement manufacturers, alleging those manufacturers engaged in deceptive advertising and misleading marketing. These lawsuits have been filed in courts across the nation against defendants ranging from Walgreens and Walmart to Perrigo, Supple, and Living Essentials. And recent data suggests that personal injury lawsuits against dietary supplement manufacturers and suppliers are being filed with increasing regularity.

Media coverage portraying dietary supplements in a negative light is also increasing. Most recently, news outlets such as Good Morning America, NPR, HBO, and The New York Times have covered the issue. This increased media attention almost certainly portends more frequent and more serious attention from lawmakers and litigants, both public and private, alike.

In light of these developments, manufacturers, distributors, and merchants of dietary supplements are advised to consider the following actions:

  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 promise to come quickly but not to be consistent across states.
  3. Implement policies to ensure compliance with the laws of every state in which business is being done.
  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, is of the essence. The legal and political landscape is changing, 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 litigation team 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 this area of law in the State of Alabama. For example, one of the cases we handled resulted in a decision by the Alabama Supreme Court that a medical device manufacturer cannot be held liable for fraud under Alabama law unless there is an injury-producing malfunction of the device, even if there is a substantial risk that the implanted medical device may one day fail.