Californias Proposition 65

You may see the following statement included on the packaging of some of our products:

WARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm.

California’s Proposition 65 requires a warning applicable ONLY TO CALIFORNIA CONSUMERS – this warning does not apply to consumers in any other U.S. state or other countries.

This warning statement is a requirement under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 or “Proposition 65” as it is more commonly known. 

Please note that this warning does not mean that any particular product is unsafe or in violation of any product safety standard or requirement. All Transform™ supplements are formulated and manufactured within strict FDA limits and comply with all relevant and internationally recognized product standards and safety criteria set forth by the World Health Organization.

Frequently asked questions in relation to Proposition 65:

What is California’s Proposition 65?

Proposition 65 (“Prop 65”) is a California initiative to address concerns with human contact with toxic chemicals, originally dubbed “The Safe Drinking Water and Toxic Enforcement Act” in 1986. The state of California updates the list annually, and it now consists of over 800 chemicals.

Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. These chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals.

Where does the law apply?

This law only applies to the state of California. Every other state complies with federal limits, and other countries abide by international World Health Organization limits.

What are the limits?

California’s Prop 65 sets limits that are significantly lower than any other system in the world. While every Transform™ supplement is tested to be well below the limits set by the World Health Organization and the limits found in many prescription pharmaceutical products, California’s proposed limits are often below the amounts found in naturally grown, healthy fruits and vegetables or other organic products. Below is a comparison of Prop 65 limits for lead as compared to the rest of the world.

      • NSF International limit for lead (mcg/day, orally): 20 mcg
      • California Proposition 65 cancer limit for lead: 15 mcg/day
      • World Health Organization lead limit: 10 mcg/day
      • United States lead limit for pharmaceuticals: 3 mcg/day
      • California Proposition 65 reproductive toxin limit for lead: .5 mcg/day
How are limits set?

The California Agency responsible for administering Proposition 65, the Office of Environmental Health Hazard Assessment (“OEHHA”), has developed safe harbor levels, or a Maximum Allowable Dose Level (“MADL”). A business has “safe harbor” from Proposition 65 warning requirements if exposure to a chemical occurs at or below these levels. According to the OEHHA website (www.oehha.ca.gov), the State of California uses the following criteria to determine the MADL for reproductive toxicants:

“For chemicals that are listed as causing birth defects or reproductive harm, the State determines the “no observable effect level” by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. Proposition 65 then requires this “no observable effect level” to be divided by 1,000 in order to provide an ample margin of safety. Businesses subject to Proposition 65 are required to provide a warning if they cause exposures to chemicals listed as causing birth defects or reproductive harm that exceed 1/1000th of the “no observable effect level.”

What kinds of food are affected?

Almost all foods contain some level of one or more of the substances recognized by the State of California. In most cases, the exposure levels established by Prop 65 are less than what occurs naturally in fruits, vegetables, and even drinking water. However, food producers are not required to provide Prop 65 notices.

I’m not in California; why does my product still have a Prop 65 Warning?

Although Proposition 65 only applies in California, we distribute and sell our product across the United States and to other countries throughout the world. It is difficult to determine whether any particular product will ultimately be distributed or used in California, so the warning is added to all of our products as a precaution.

Are transform supplements safe to consume?

Transform™ works directly with suppliers to source every ingredient used in our products. Our FDA Registered, NSF cGMP Certified facilities hold some of the strictest and most prestigious third party certifications in the nutrition industry and test and qualify each individual ingredient to ensure identity, quality, and purity before being used in the manufacturing of any of our products. All finished supplements are also tested post-production to confirm that each product meets the required specifications, safety standards, label claims, and requirements for heavy metals and microbial contamination.

Transform™ is committed to providing the highest-quality and most efficacious supplements available in sports nutrition. Through careful sourcing and rigorous testing, we ensure that only the best ingredients are used in every Transform™ product.

For more information about California’s Proposition 65, go to https://www.p65warnings.ca.gov/food.

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