Seriously – Aloe Vera Whole Leaf Extract May be a Prop 65 Chemical

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We’ve recently written a series of articles about “natural” personal care products that may inadvertently run afoul of Prop 65 regulations.  You may be surprised to learn that such “natural” products may include ingredients that have been identified as “chemicals known to the State of California to cause cancer” under Proposition 65.

One of the more surprising of the proposed Prop 65 ingredients is Aloe Vera Whole Leaf Extract.  On April 23, 2015, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued its notice of intent to list Aloe Vera Whole Leaf Extract as a chemical known to cause cancer. Although more than 420 species of Aloe plant exist, the specific form that is the subject of the proposed listing is: “Aloe Vera whole leaf extract” which “consists of the liquid portion of the Aloe Vera leaf and is a natural constituent of the Aloe barbadensis Miller plant.”  Fortunately, OEHHA specifically excludes Aloe Vera decolorized whole leaf extract, Aloe Vera gel, Aloe Vera gel extract and Aloe Vera latex, which are the more common forms used in personal care products.

When it issued the notice of intent to list Aloe Vera Whole Leaf Extract, OEHHA also issued a notice of intent to list Goldenseal Root Powder as a chemical known to cause cancer. OEHHA identified goldenseal root powder in the proposed listing as “the powdered dried roots and underground stems of goldenseal plants” and declared it to be “a natural constituent of the goldenseal plant.” OEHHA further specifies that Goldenseal is also known as Hydrastis Canadensis, orangeroot, Indian turmeric, and curcuma. Fortunately, OEHHA further specifies that the spice turmeric (Curcuma longa Linn.), frequently found in personal care products such as face and body lotions and cleansers, is not proposed for listing. The form of goldenseal root extract that is contemplated for addition to the Prop 65 list is most often used in the form of nutritional supplements.

Even when manufacturing or distributing “natural” products, beauty companies should take care to review the products’ current formulations to determine whether they contain an ingredient that is or may be on the Proposition 65 list, or whether any of their products contain an ingredient that may cause an exposure to a Prop 65 chemical.  It may be vital to work closely with manufacturers or suppliers, and have strong contracts to protect against Proposition 65 liability. Companies should be pro-active and consider reformulation if a proposed or actual Prop 65 chemical is being used.  And if a Proposition 65 Notice of Violation is received, affected companies should promptly contact counsel with experience in successfully resolving Prop 65 claims.

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Beauty Companies Beware: Natural Ingredients May be Subject to Prop 65

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Personal care product companies are riding the wave of strong consumer interest in “natural” products.  However, going “natural” can come at a cost:  In addition to concerns about drawing consumer claims that the term is being used in a potentially deceptive manner, there are other hidden risks to manufacturers, distributors and resellers of “natural” products. Perhaps surprisingly, a number of chemicals that are commonly found as a natural constituent of plants has been or is about to be classified as “chemicals known to the State of California to cause cancer” under California’s Proposition 65.

Pulegone is among the plant extracts found on the Prop 65 list.  Pulegone is a natural constituent of various plants, including mint and other herbs, and of their essential oils.  Pulegone was added to the Prop 65 list on April 18, 2014 as a chemical known to the state of California to cause cancer, and it became subject to enforcement actions a year later, on April 18, 2015.  Prop 65 bounty hunter Mateel Environmental Justice Foundation wasted no time in sending out a 60-Day Notice of Violation to businesses whose products involve exposure to this chemical.  It only took two days for the first Notice of Violation over exposure to pulegone to be served on businesses around the country.  A Notice of Violation is often a pre-cursor to a lawsuit.  The Notice of Violation claims consumer and occupational exposures to pulegone through use in products of pennyroyal oil.

The requirements of Proposition 65 are deceptively simple – provide a clear and reasonable warning if the use of the product results in an exposure to one or more of the 800+ chemicals on the Prop 65 list of known carcinogens and reproductive toxins.  But the penalties, fees and damage to business reputation for failing to comply can be severe:  Under Proposition 65, the civil penalties for failing to provide a clear and reasonable warning prior to exposure can reach up to $2,500 per violation per day, in addition to payment of an enterprising plaintiff’s attorneys’ fees.  Wherever they are located, manufacturers, distributors and retailers can be liable for Prop 65 violations, and the sale of even one product that may cause an exposure to a Prop 65 chemical is subject to zealous pursuit by Prop 65 plaintiffs.  Businesses are well advised to consult with counsel who are familiar with Prop 65 concerns and can help them proactively get ahead of the Prop 65 curve or successfully resolve claims in the event a Notice of Violation is received.

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Chemical Peel Ingredient Trichloroacetic Acid (TCA) Requires a Proposition 65 Warning

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Trichloroacetic acid (TCA), a chemical that is commonly used in cosmetic treatments such as chemical peels and for the removal of tattoos and treatment of skin tags, warts and moles, is now subject to Proposition 65’s warning requirement.  This means that any exposure to the chemical in California requires a warning that the chemical is “known to the State of California to cause cancer.”  The penalties for failing to provide the warning as required by Proposition 65 can be substantial:  The law authorizes civil penalties of up to $2,500 per day per violation.  In addition, attorney fees are authorized by California’s private attorney general statute – creating incentive for private Proposition 65 “bounty hunters” and their lawyers to target businesses who fail to comply.

Under Proposition 65, no legal action is authorized by the Attorney General, district attorneys or private enforcers until 12 months after the listing of that chemical.  TCA (CAS No. 76-03-9) was added to the list of chemicals known to the state of California to cause cancer on September 13, 2013.  As a result, Proposition 65 private enforcers were allowed to start sending out Notices of Violation over alleged exposure to TCA without a warning beginning on September 14, 2014.  The law permits such private enforcers to file a lawsuit 60 days after the Notice of Violation is served.

In addition to TCA, the following chemicals became subject to Prop 65 enforcement action on September 14, 2014:  chloral (CAS No. 75-87-6), chloral hydrate (CAS No. 302-17-0) and 1,1,1,2-tetrachloroethane (CAS No. 630-20-6).

Conkle, Kremer & Engel has significant experience in helping businesses understand and comply with the requirements of Proposition 65 and other regulations to avoid exposure to liability.  In addition to working with businesses to develop an effective compliance strategy, CK&E handles all aspects of Proposition 65 defense, including responding efficiently if a Notice of Violation is received.

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Happy Anniversary: 1,3-Dinitropyrene Becomes Subject to Prop 65 Enforcement on November 2, 2013

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Starting November 2, 2013, Proposition 65 enforcement actions may be taken against businesses for exposure to the chemical 1,3-dinitropyrene without a clear and reasonable warning.  1,3-dinitropyrene was added to the Prop 65 list of chemicals on November 2, 2012 as a chemical known to the state of California to cause cancer.  Under Prop 65, enforcement actions may not be taken for one year after the listing, so as the anniversary arrives on November 2, 2013 this chemical will become subject to enforcement actions.  1,3-dinitropyrene is an environmental contaminant that has been measured in engine exhaust and emissions from kerosene heaters and gas burners.

Also starting November 2, 2013, alpha-methyl styrene is actionable as a chemical known to the state of California to cause cancer, based on its November 2, 2012 listing.  Alpha-methyl styrene is used in the manufacture of plasticizers, resins and polymers.  However, for all practical purposes, the addition should not affect businesses’ obligations to warn about exposure to alpha-methyl styrene, as it was already listed in 2011 as a chemical known to cause reproductive toxicity.

The Office of Environmental Health Hazard Assessment (OEHHA) has not established any specific safe harbor levels for either 1,3-dinitropyrene or alpha-methyl styrene.

Conkle, Kremer & Engel routinely counsels clients on regulatory compliance, including compliance with Proposition 65.  We monitor the latest developments to Prop 65 in order to provide expert guidance to companies doing business in California.

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