For years, manufacturers, distributors, and suppliers of dietary and herbal supplements—reported to be a $32 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 are numbered.
At the outset, it is important to understand the universe of products at issue here. Dietary and herbal supplements range from energy drinks such as 5-hour ENERGY® to the myriad vitamins and mineral supplements on the shelves of pharmacies and nutrition centers around the country.
The industry now finds itself in a precarious position—between the crosshairs of federal and state regulators:
- 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, the FDA asked the court to halt the manufacture and distribution of the products.
- In a recent 16-month period alone, the FDA reportedly took more than 100 actions against the makers and sellers of dietary supplements.
- Just last month, the FDA sent warning letters to the manufacturers of approximately 30 dietary supplements, directing them to cease the sale of products containing allegedly dangerous ingredients.
- In February of this year, the New York Attorney General issued cease-and-desist letters to GNC, Target, Walmart, and Walgreens for allegedly selling adulterated herbal supplements.
- Then, in April, 14 attorneys general asked Congress to launch an investigation of the herbal supplements industry and to consider giving the U.S. Food and Drug Administration stronger oversight of the industry.
If large-scale litigation against manufacturers of other products is any indication, other states and private plaintiffs' attorneys are certain to follow suit. Indeed, a number of putative nationwide 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 and herbal supplement manufacturers and suppliers are being filed with increasing regularity. Because it is only a small step from a drug or device lawsuit to a personal injury suit against the manufacturer of a dietary or herbal supplement, repeat players on the plaintiffs' side of drug and device litigation are likely to enter the supplement arena.
So, too, have supplements become a topic du jour in the media. Popular news outlets such as ABC News, 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 and herbal supplements are advised to consider the following:
- Work with governmental affairs specialists to have a voice in shaping the policies of federal and state governments.
- Stay abreast of updates in the law, which may come quickly but not be consistent across states.
- Implement policies to ensure compliance with the laws of every state in which the company is doing business.
- Take steps to reduce exposure to personal injury and consumer protection lawsuits.
- 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 attorneys should advise their clients to be better positioned to anticipate and respond appropriately to legal and political challenges.
Keywords: products liability, litigation, supplements, dietary, herbal