Firms marketing food and supplement products in California should expect Proposition 65 enforcement actions to continue because, even as industry calls for FDA to intervene, chances for relief will not come soon, experts say.

While some in the industry are urging FDA to look at the impact of Prop 65 on federal regulation and policy, under a new administration and lacking a commissioner it is unlikely the agency will take on the law soon, according to food and drug attorney Brian Donato.

Moving to change Prop 65 would require "the whole agency committed to the enterprise," said Donato, of Washington-based Hyman, Phelps and McNamara.

"You have to deal with this. It would be wise to have somebody help you understand the requirements and understand what levels might be in your products."

He said few firms will forego marketing products in California, where the population reached 37 million in 2008, according to the U.S. Census Bureau.

American Herbal Products Association President Michael McGuffin also is advising supplement manufacturers to recognize that Prop 65 "is not going to go away."

Amending Prop 65 would require a two-thirds majority in the legislature because the 1986 law was enacted by popular referendum, McGuffin said at a Jan. 30 Food, Drug and Law Institute conference in Washington.

"It is a lot less painful if you are informed on this, if you are marketing products in California and taking the appropriate steps to comply with this law," he said. "It's quite expensive to find yourself at the wrong end of one of these complaints."

Daniel Fabricant, VP of scientific and regulatory affairs at the Natural Products Association, said "it is important to bring FDA into the picture," but the agency's chances in taking on the law do not appear strong. California's 54-member congressional delegation would likely "have a problem if FDA starts looking at state pre-emption," he said.

"Pre-emption is not really an option. For the time being, we're stuck with it," Fabricant added.

Firms subject to Prop 65 also should "become familiar with their own products and the level to which their products might contain any listed chemicals," he said.

Prop 65 requires that labels for products with certain levels of some 800 listed chemicals must include "clear and reasonable" warnings of cancer and reproductive toxicity risks.

Prop 65 lawsuits have been frequent because levels set by the law for some chemicals are below FDA's provisional total tolerance intake levels.

In December 2008, California and some counties in the state filed complaints against 56 multivitamin manufacturers and marketers alleging they failed to warn consumers of lead exposure in their products.

Swanson Wants Agency To Discuss Prop 65

Swanson Health Products on Jan. 29 renewed its January 2008 citizen petition for FDA to conduct a public meeting to consider Prop 65's impact on federal regulation and policy (¹ 'The Tan Sheet' Jan. 28, 2008, In Brief).

Swanson asserts Prop 65 "causes consumer confusion" and "misbrands" safe products.

An attorney for Swanson, Stephanie Sheridan of Sedgwick, Detert, Moran & Arnold in San Francisco, said the recent Prop 65 lawsuits "in part" fueled the firm's renewed request.

A Feb. 4 HPM FDA Law Blog noted Swanson's latest submission to FDA and recent reports of potential mercury contamination related to high fructose corn syrup. If this news "begets another Proposition 65 action, we're betting that this citizen petition will find a few more friends," attorney Ricardo Carvajal wrote.

Industry experts say the latest Prop 65 lawsuits were linked to FDA's survey on lead levels in herbals, which Rep. Henry Waxman, D-Calif., requested after ConsumerLab.com alleged lead levels were high in a Vitamin Shoppe product (² Also see "Waxman Seeks FDA Action Following ConsumerLab Vitamin Lead Testing" - Pink Sheet, 9 April, 2007., p. 6).

FDA published data on lead levels in 324 vitamin products for women and children in August, noting the products fall below safe and tolerable levels. (³ Also see "FDA Survey Shows Lead Labeling Not Needed For Supplements – Stakeholders" - Pink Sheet, 11 August, 2008., p. 8).

However, California's attorney general took issue with some products, noting they were above Prop 65 levels and did not give appropriate warning. The suits were filed Dec. 23 after the Carrick Law Group notified firms that FDA found lead in their products (⁴ 'The Tan Sheet' Jan. 12, 2009, In Brief).

"It is easy to imagine that this scenario could repeat itself with other contaminants that are the focus of future FDA surveys or of FDA's increased inspectional activities" under the supplement good manufacturing practices, Carvajal and HPM colleague A. Wes Siegner wrote in a Jan. 29 FDA Law Blog.

Swanson's latest letter to FDA notes supplement firms recently sued by California will likely do "as so many have done before them" and settle for a "large monetary" amount, because they lack the finances to fight the state for "years in court."

"Lack of certainty concerning how food and dietary supplement manufacturers should comply with Proposition 65 continues to pose grave challenges to the industry," Sheridan said in an e-mail.

Donato also pointed out the expense of litigation is a deterrent to contesting Prop 65 complaints. "A lot of this is just going through a long series of litigation activities - including discovery, the filing of motions and so forth, and then resolving the case by settlement."

Donato said while there has been agency concern in the past, FDA is not likely to hold a public hearing on the issue anytime soon.

"I guess the tension here is between FDA's role as the national expert agency making decisions on the safety and safe use of certain products and the somewhat contentious rule of Prop 65 being enforced particularly by the private attorneys general," he said.

Differences Clear, But Not The Science

In a Jan. 29 Natural Products Foundation blog, board member James Roza says it is clear FDA and California differ in "what constitutes a safety hazard."

"We need some rational discourse on both the federal and state level to clearly assess what dangers lurk in the foods, supplements and beverages we ingest," adds Roza, an executive with Somerset, N.J.-based private labeler Reliance Vitamin. Prop 65 has "resulted in frivolous lawsuits that consume taxpayers' time and money," he says.

NPA's Fabricant said firms are concerned in part because Prop 65's maximum allowable daily levels for substances are "scientifically arbitrary," and "bad science leads to confusion."

"How do you fight back against an unscientific standard?" he added.

In Prop 65 suits "you really are innocent until proven bankrupt. In a lot of instances, it is better to settle out of court," Fabricant said.

However, Donato noted, California is looking into whether there is a risk of "overwarning" consumers. "If you slap a warning on everything and everyone is in compliance with the requirement, the warning can lose impact," he said.

Donato emphasized that firms should have experts assess their products. "I would rather know, if I was defending a company, what I had [in a product] and make a decision as to whether I should give the warning or not, than to wait for a lawsuit and find out I'm in trouble then."

Donato said it appears while many people do not believe the law produces the "desired effect," California consumers are convinced of it. The real goal of Prop 65, he said, is to either get companies to eliminate or lower chemical amounts in products.

While the law only requires a clear and reasonable warning, Donato says the intent is to "motivate a company to say, 'I don't want to have to give this warning, so I'll take the chemical out or reduce the level,'" he said.

Donato, who previously worked in California for HPM, said he would urge firms "to find the resources that can help them determine what is in the products" since Prop 65 litigation shifts the burden to defendants to prove their products have levels lower than allowed. He noted naturally occurring chemicals are considered exempt, but that distinction can be difficult to prove.

- Katie Stevenson (k.stevenson@elsevier.com)

Arbitrary Or Not, Prop 65 Standards Look Likely To Continue – Experts

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