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Prop 65 Dietary Supplements, Homeopathic Medicine Litigation
Supplements Creating Elevated Testosterone Levels Not Subject To Prop 65
On January 10, 2001, Judge Marilyn Hoffman of the Los Angeles Superior Court dismissed the cases filed against numerous supplement manufacturers by Consumer Cause, on the ground that plaintiff had failed to allege an exposure subject to Prop 65. The plaintiff had contended that the defendants' products, after ingestion, caused an elevation in testosterone levels. Plaintiff contended that the defendants were required to provide warning, as testosterone is a Prop 65-listed carcinogen.
The court agreed with the defendants that plaintiff's theory made it impossible to prove that the exposure created "no significant risk," and that the varying levels of testosterone made the issue of detectability impossible. The court held that applying Prop 65 in this case would violate due process, by requiring companies to guess at its meaning and application.
Read the trial court's ruling in Consumer Cause v. Weider Nutritional (note: this document is an executable application; it's not a virus, and can be safely run).
On April 24, 2001, the Attorney General field an amicus brief in Consumer Cause's appeal, arguing that both plaintiff and defendant incorrectly interpreted the law, but that the summary judgment should be affirmed.
The AG disagreed with the defendant's assertion that a product must "contain" a chemical in order for there to be liability under Prop 65, holding that numerous chemicals (such as diesel exhaust and tobacco smoke) are not "contained" in products, but exposures to them were actionable. The AG stated that any bodily contact with a listed chemical is what Prop 65 is intended to address, and it makes no difference whether the product contained the chemical, or released a chemical that was converted to a listed chemical prior to bodily contact.
The AG took the position that the state could even list a chemical that was not a carcinogen, but which was converted by the human body into a carcinogenic chemical. However, since the supplements at issue had not been listed by the agency directly, the AG disagreed with Consumer Cause's view that exposure occurs if the human body creates the listed chemical. The AG stated that drawing the line at the point of contact with the human body also clarifies the issue of exposure vs. no significant risk. If the body contacts a chemical, then plaintiff has met its burden of proof. If the chemical is subsequently changed by the body, then the defendant can use such change as a means of demonstrating that there is no significant risk.
Court of Appeal Affirms Dismissal
On September 18, 2001 the California Court of Appeal, Second District, Division Five, affirmed the trial court's judgment in favor of Weider. Read the opinion [Word/pdf].
The court concentrated on the meaning of the term "expose" in section 12201 of the California Code of Regulations, title 22. The court agreed with the AG's position that " ' "Contact" occurs at the first pion at which the body connects with a chemical from outside the body. It does not include what happens inside the body to transform the chemical into something else." ' " According to the court, "In the absence of anything in the statutory language, regulations or the Proposition 65 voter pamphlet indicating the act was to apply in these circumstances, the trial court correctly sustained the demurrer without leave to amend."
AG Claims Andro is a Listed Chemical
On August 16, 2001, shortly before the decision from the Court of Appeal in Weider, the Attorney General filed an action against many of the same manufacturers of androstenedione. This time, the allegation was not that andro created elevated testosterone levels but, rather, that andro is an "anabolic steroid," listed as a male and female reproductive toxin.
Neither the Prop 65 listing nor California Civil Code section 1812.97 governing warnings for anabolic steroids list andro as a covered chemical. The Attorney General's complaint relies upon several other sources for that conclusion, including the banning of andro as an "anabolic" agent by the Olympics, NCAA, and NFL.
Supplements and Homeopathic Medications Not "Alcoholic Beverages"
In a series of 60-day notices served in December 2000, Consumer Cause has asserted that a large number of companies are violating Prop 65 by failing to warn of exposures to "ethyl alcohol" in homeopathic medications. Alcohol has long been used as a diluent for such medications.
Although the Prop 65 listing of ethyl alcohol is restricted to "ethyl alcohol in alcoholic beverages," Consumer Cause claims that a common sense reading of the term alcoholic beverages, as well as the definition of the such beverages in the state Alcoholic Beverage Control Act, render them within the definition of the Prop 65 listing. The manufacturers and distributors who received notices are expected to contend that the agency was referring to traditional alcoholic beverages (such as beer, wine, and distilled spirits) when it listed ethyl alcohol.
In 1997, an unfair competition action brought against one of the manufacturers resulted in a judgment holding that the homeopathic medications were not alcoholic beverages under the ABC act. It is unclear how this ruling will affect the Consumer Cause claims.
On March 21, 2001 Consumer Cause filed a lawsuit in Los Angeles Superior Court against numerous defendants, alleging Prop 65 and unfair competition claims over exposures to alcohol. Consumer Cause, Inc. v. Arkopharma Laboratories, Inc., et al., no. BC247097 Like the testosterone litigation, it is anticipated that these claims will be challenged by demurrer.
Court Dismisses Claims and Rejects Settlement
On October 9, 2001 Judge William Highberger of the Los Angeles Superior Court sustained the defendants' demurrers to the complaint and dismissed the claims. Download the minute order [pdf]. The court found the following arguments persuasive:
- Neither state nor federal governmental agencies have taxed the products as "alcholic beverages," despite use of the same legal definition as advanced by plaintiff;
- The Attorney General had taken the position that the products were not alcoholic beverages;
- The commonsense lay understanding of these products is that they are not intended to be used as alcoholic beverages
In light of this ruling, the court subsequently rejected a proposed settlement between plaintiff and one of the defendants that had been reached prior to the ruling on the demurrers, but had been subject to the 30-day Attorney General review. Download the minute order [pdf]. The order stated that the court was not inclined to approve the proposed consent judgment, in light of the core legal rulings in the demurrer, and invited the parties to submit further briefing if they believed that the ruling did not control. The settling defendant and plaintiff subsequently stipulated to entry of judgment in favor of the defendant, and to resubmit the settlement to the court if the order sustaining the demurrer were reversed on appeal.
A July 29, 2002 amicus brief filed in the Court of Appeal (Second Appellate District, no. B157805)by the Attorney General supported the defendants' argument that the dietary supplments at issue in the case were not "alcoholic beverages." The brief avoided discussion of the definition of alcoholic beverages in other statutes and regulations, and focused on the intent of the Science Advisory Panel to list alcoholic beverages "in their typical sense, i.e., that class of products that is regulated by the Department of Alcoholic Beverages Control and which cannot be purchased by persons under age 21." The AG disagreed with the defendants' assertion that construing the Prop 65 listing to include their dietary supplements to be within the listing of "alcoholic beverages" would violate their due process rights.Attorney General's Amicus Brief Supports Defendants
Court of Appeal Affirms Dismissal
In an opinion published on February 28, 2003, the Court of Appeal affirmed the trial court's order sustaining the demurrers to the complaint. The court acknowledge that neither Prop 65, nor the listing of “ethyl alcohol in alcoholic beverages” defined “alcoholic beverage.” Following the defendants' argument, the court looked "to the definition and use of this term in other statutes as a guide to its meaning in regulations promulgated pursuant to Proposition 65." "[T]he Proposition 65 regulation listing “ethyl alcohol in alcoholic beverages” recognizes a distinction between alcohol used in a beverage and alcohol used in other products for human consumption which are not beverages. Although they contain alcohol and are made for human consumption, defendants’ products are not intended to be consumed in a manner, or in such quantities, as to constitute 'beverages.' " Download the opinion [Word/pdf].
s You Sow Settles with Chinese Medicine Distributor
Under a September 17, 2001 consent judgment in As You Sow v. Mayway Corp., the defendant has agreed to provide English and Chinese warnings over exposures to lead, arsenic, mercury, and cadmium from its Chinese patent herbal medicines. The consent judgment also prohibited Mayway from making any "fraudulent, unfair, deceptive, untrue or misleading representations regarding the purity, safety, heathfulness or contents of the products." Mayway will pay a $10,000 civil penalty, an $120,000 restitutionary payment to As You Sow, and an $80,000 attorney's fees payment.
This page last updated January 14, 2002.
