A Slippery Slope

September 30, 2009

This summer came with its fair share of FDA (Rockville, MD) intervention. Warning letters were sent out, products were recalled, and millions of dollars were won in federal lawsuits over dietary supplements. So what types of products have been making a stir in the supplements industry, and what are companies doing to protect themselves?

Lifestyle products-such as those for weight loss, sexual performance, and bodybuilding-have always received attention from consumers and industry watchdogs alike. Several incidents this summer hit lifestyle product companies that were making false claims or using adulterated substances. Erectile Dysfunction drugs adulterated with anabolic steroids and the scandal involving American Cellular Labs' bodybuilding products were a few focuses of summer reports.

"Products bearing claims that are far too good to be true tend to be from 'lifestyle' categories, where consumers are looking for a 'quick fix' or magic bullet," says Douglas MacKay, ND, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN; Washington, DC). "Consumers know better, but many still fall victim to the need for immediate results and gratification."

Andrew Shao, PhD, vice president of scientific and regulatory affairs at CRN, believes that the lifestyle sector is also often associated with adulteration issues. "With rare exceptions, dietary supplements do not have strong and immediate effects," says Shao. "In order to deliver on such a promise, such supplements would have to be adulterated with drugs."

FDA and the Federal Trade Commission tend to focus efforts on cases in which consumers are flocking to an unsafe product. The higher the risk of a product, the more attention it receives from a federal regulatory agency.

FDA's risk-based enforcement policy seems fitting with its low-level funds and resources, but what happens when good actors in the industry find themselves in binds with FDA?

John Villafranco is a lawyer with Kelley Drye & Warren LLP (Washington, DC), specializing in advertising law and consumer protection. "Remember, when FDA acts, it's not always because they are 'busting' a bad actor," says Villafranco. "It's often because of reports of adverse events…Good, responsible companies could find themselves in the very difficult position of having to decide whether to recall a product based on just a few adverse events that make up a tiny percentage of total sales. And when they do recall a product, FDA will issue a press release, and these companies then become the target of plaintiff's attorneys. These attorneys will bring consumer class-action cases that are very costly to defend and will substantially disrupt business operations."

Making matters more difficult, the language of FDA rules can be complicated. FDA is facing lawsuits over its published language. New regulations are drafted and then sometimes enforced only intermittently, says Villafranco.

So what are companies doing to make operations easier? Some companies utilize the services of self-regulatory agencies to help avoid FDA debacles and litigation fees.

The National Advertising Division (NAD; New York City) of the Council of Better Business Bureaus is one example. When a product's advertising claims are challenged by any party, NAD acts as an objective third party that reviews all available scientific evidence regarding the product and ultimately assesses the credibility of its claims. The procedure provides product assessment without the penalties that could result from action by government agencies. NAD reviews can also bolster the credibility of a company and its products.

"Increased utilization of industry self-regulation can preserve federal resources to go after real egregious offenders that are willingly ignoring current regulation and eroding consumer confidence," says MacKay.

In the meantime, FDA rules are still changing. A controversial section of FDA's Amendment Act (FDAAA) of 2007 is currently pending implementation. Section 912 would prohibit the sale of foods that have added approved drugs. This can create a debate over a food product, such as red yeast rice, which naturally contains an FDA-approved statin used in cholesterol-lowering drugs. Experts also warn that FTC is drafting a final version of its Guides Concerning the Use of Endorsements and Testimonials in Advertising.