Both food manufacturers and supplements makers have long complained about California's Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65. Intended to warn consumers about reproductive toxins and carcinogens, the law enforces labeling for products with as little as 1/1,000th of the level of a given toxin known to cause harm. More than 800 chemicals are listed, though many of these occur naturally in the environment and cannot be removed.
Now, Swanson Health Products of North Dakota has filed a petition with the U.S. Food and Drug Administration, arguing that Prop 65 conflicts with federal food and supplement regulations. Under the Federal Food, Drug and Cosmetic Act, the FDA has authority to establish food safety standards and GMPs, and to regulate labeling.
"We think the time is absolutely right for this challenge," said Stephanie Sheridan of Sedgwick, Detert, Moran & Arnold LLP, the law firm representing Swanson. Sheridan cited three areas in which Prop 65 conflicts with FDA jurisdiction. "First, FDA's new good manufacturing processes fail to recognize a zero tolerance level for contaminants, and Prop 65 is essentially zero tolerance. Second, we argue that Prop 65 causes misbranding, and FDA has recently issued two letters that go to the heart of the misbranding issue, including one that states that a Prop 65 warning on tuna with mercury misbrands tuna. Finally," Sheridan said, "the Food Protection Plan adopted by FDA to combat terrorism is really diminished if every food and dietary supplement has a warning label on it."
The dietary supplements industry has long felt that Prop 65 leads to bounty hunting on the part of litigators, who can sue manufacturers, force them to settle, and receive a portion of the settlement. This is particularly an issue with lead, which occurs naturally in the environment.
"Lead is by far the most significant substance that bedevils many industries under Prop 65," said Loren Israelsen of LDI Group, an industry consulting firm based in Salt Lake City. "Prop 65 has been transformed from something well-intended to something predatory that enriches private bounty hunters. Lead is ubiquitous in the environment, and analytical technology makes it possible to find anything in anything."
And because levels are set so low, every product is at risk of lawsuits. "The law is triggered even if the substance is a thousand times less than cause for concern," said John Hathcock, Ph.D., vice president for scientific and international affairs at the Council for Responsible Nutrition. "You can call that a safety margin, but it may be more accurate to call it a paranoia factor."
The question is whether the FDA will act. "I think they'll only get involved if there's no way out," said Israelsen.
Lawyers at Sedgwick, Detert, Moran & Arnold LLP are more hopeful. "[The] FDA has established a docket number for our citizen's petition and has 180 days to respond," Sheridan said. "We've already received encouragement from other companies stung by huge settlements for their own products."
Interested parties, such as other supplements manufacturers, can look up docket number FDA-2008-P-0049-0001/CP on the fda.gov Web site and offer comments, or view information on the petition at http://sdma-web.com/email/gen_alert/01_jan_08_prop65_2.htm