Major Prop 65 Changes Coming In Six Months – What You Need To Know

I just wanted to give you a heads up on the latest and greatest from California and some amendments to its infamous Prop 65 that are going into effect in August 2018 (less than six months).

Any company with ten or more employees that operates within the state or sells products in California must provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical in an amount exceeding established standards set forth in Prop 65’s regulations. The regulations specifying warning content that provides a safe harbor under Proposition 65 are currently in transition.

Under Prop 65, consumer goods sold in California generally must provide a “clear and reasonable warning” if chemicals listed by the state as “carcinogens” or “reproductive toxicants” are present above specified limits. California amended Prop 65 warning requirements in August 2016, and the changes are scheduled to go into effect in August 2018.  If you would like to see the new regulations, you can find them at this link – https://govt.westlaw.com/calregs/Browse/Home/California/CaliforniaCodeofRegulations?guid=I498B7BC4FCC04E1FA663C4E3EC97D6A5&originationContext=documenttoc&transitionType=Default&contextData=(sc.Default)

Warning content in effect until August 30, 2018

Currently, for consumer goods, this warning is generally given by means of stating on the label, a sign at point of display, or the internet page bearing the product description:

• For any chemical listed as a carcinogen:  WARNING: This product contains a chemical known to the State of California to cause cancer.
• For any chemical listed as a reproductive toxin: WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.
• For any chemical listed as both a carcinogen and as a reproductive toxin:  WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.

It is important to understand that Proposition 65 does not forbid the sale of products that contain listed chemicals in amounts that might exceed the standards or even in amounts that might cause harm.  Rather, the law places an obligation on companies to provide “clear and reasonable” warnings if they choose to sell such products into California.

Warning content in effect after August 30, 2018

On August 30, 2016, OEHHA (Office of Environmental Health Hazard Assessment) adopted new regulations for the provision of clear and reasonable warnings. The original warning regulations (as provided above) will sunset on August 30, 2018. In the interim, businesses may comply with the regulations currently in effect (as provided above), or the provisions of the new regulation. This will allow for a reasonable transition period for businesses to begin providing warnings under the new provisions. Key changes in the new safe harbor warning regulations include the following:

Warnings must be provided prior to a consumer’s purchase of the product rather than prior to exposure;

• For warnings that are not given on the product of its immediate packaging, warnings must include the name of at least one chemical for which the warning is being provided;
• For products that provide consumer information in a language other than English, warnings must also be provided in that language in addition to English;

The OEHHA Proposition 65 website URL must be provided. Examples of the new warnings as applicable to food and dietary supplements are as follows:

• For any chemical listed as a carcinogen: WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go towww.P65Warnings.ca.gov/food.
• For any chemical listed as a reproductive toxicant: WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go towww.P65Warnings.ca.gov/food.
• For a chemical listed as a carcinogen and a different chemical listed as a reproductive toxicant: WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go towww.P65Warnings.ca.gov/food.
• For any chemical listed as both a carcinogen and as a reproductive toxicant: WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go towww.P65Warnings.ca.gov/food.

Where a warning is being provided for an exposure to a single chemical, the words “chemicals including” may be deleted from the warning above, but in that circumstance the warning will only cover the identified chemical. Where the warnings above are provided on a food or dietary supplement product label, the warning must be set off from other surrounding information and enclosed in a box.

Companies can also comply with the warning regulation using the on-product warning option. This warning option contains a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline placed to the left of the warning text, as well as the following:

• For consumer products that cause exposures to a listed carcinogen:  WARNING: Cancer –www.P65Warnings.ca.gov.
• For consumer products that cause exposures to a listed reproductive toxicant:  WARNING: Reproductive Harm –www.P65Warnings.ca.gov.
• For consumer products that cause exposures to both a listed carcinogen and a reproductive toxicant:  WARNING: Cancer and Reproductive Harm –www.P65Warnings.ca.gov.

If the sign, label, or shelf tag for the product is not printed using the color yellow, the symbol may be provided in black and white. The warning symbol can be downloaded from the OEHHA website.

For on-product warnings, the warning language must be no smaller than the largest type size used for other consumer information on the product, and in no case shall the warning appear in a type size smaller than 6-point type. On-product warnings are not required to include the name or names of a listed chemical within the text of the warning.  (“Consumer information” includes warnings, directions for use, ingredient lists, and nutritional information. “Consumer information” does not include the brand name, product name, company name, location of manufacture, or product advertising.)

The Consequences of Non-Compliance

Not surprisingly, Prop 65 has given birth to a cottage industry of sleazy, ambulance-chasing attorneys who make a living suing food and supplement marketers.  I hasten to point out that much of the time, these clowns have done absolutely no testing on the products.  They simply hope to extort a quick nuisance value settlement from companies that would prefer to pay off these predators, rather than fight them.

In the past decades numerous dietary supplement companies, including marketers, contract manufacturers, and retailers, have been the subject of complaints filed or threatened by several organizations and individuals, local district attorneys and the state attorney general. These lawsuits have alleged that foods and supplement products sold by these companies contain amounts of heavy metals and other listed chemicals (primarily lead, and in some cases arsenic, cadmium and mercury) that require a warning. Companies that had not provided a warning prior to receipt of complaints have reached settlements that have resulted in payments of up to $682,000 per company, with average settlements in the range of $85,000 to $100,000 per dietary supplement company.

Also of concern is the Proposition 65 listing of several chemical constituents which are naturally occurring in some botanicals used in teas and dietary supplements. Most recently, two processed botanicals have been added to the Proposition 65 list due to the results observed after testing these materials in long-term carcinogenicity assays. Since July 2016, numerous companies that sell or manufacture tea and tea products, primarily marketers of branded finished products, have been the subject of complaints alleging violation of Proposition 65 for failure to provide the required warnings due to the presence of lead and, in a few cases, naphthalene. To date, several of these cases have been settled, either individually or through one joint settlement involving 19 defense parties reportedly acting under a joint defense agreement. Individual settlements have averaged $22,623 per company, and joint defense parties have settled for amounts ranging from $19,500 to $58,500.

More information regarding Proposition 65 warnings is available at the following link: https://oehha.ca.gov/proposition65/crnr/notice-adoption-article-6-clear-and-reasonable-warnings.