Natura-Genics : Proposition 65

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California Proposition 65

Prop65 is a broad law that applies to any company operating in California, selling products in California, or manufacturing products that may be sold in or brought into California. It mandates that the Governor of California maintain and publish a list of chemicals that are known to cause cancer, birth defects and/or other reproductive harm. The list, which must be updated annually, includes a wide variety of chemicals that can be found in many everyday items, such as coffee, dyes, solvents, drugs, food-additives, dietary supplements, and others. The purpose of Prop65 is to ensure that people are informed about exposure to these chemicals.

Prop65 also requires warnings to be placed on any product, product packaging, or literature accompanying a product that contains or may contain any of the 800-plus chemicals that the California Air Resources Board considers harmful. Many of the elements listed under Prop65 have been routinely used in everyday consumer items for years without documented harm.

All dietary supplements manufacturers that sell products in California need to make sure not to exceed the following limits established by Prop65:

Arsenic: 10 micrograms (mcg)
Cadmium: 4.1 micrograms (mcg)
Lead: 0.5 micrograms (mcg)
Mercury: 0.3 micrograms (mcg)

Evidence exits and demonstrates that any of the above elements maybe present is there only as a result of the environmental conditions in which vegetables/herbs are grown, and thus occur naturally in products. Many dietary supplements including proteins, encapsulated herbs, bars, and others containing all natural ingredients are naturally going to contain these substances. Imposed levels by Prop65 are so low for many common chemicals that are almost impossible to not surpass. In most instances, the exposure levels determined by Prop65 are lower than what occurs naturally in fruits, vegetables, grains and even drinking water.

Examples
Roasted mix nuts (no peanuts)		12.2 micrograms (mcg)
Brussel sprouts		7.9 micrograms (mcg)
Boiled spinach		7.0 micrograms (mcg)
Wine		9.0 micrograms (mcg)
Avocado		4.5 micrograms (mcg)
Watermelon		4.5 micrograms (mcg)
Cucumber		3.4 micrograms (mcg)
Apple		2.6 micrograms (mcg)

What measures should be taken to comply with Proposition 65?

Due to the high risk of enforcement action under Prop65, dietary supplement companies must take special measures to protect their business and ensure compliance with the law to the greatest extent possible.

Common steps or strategies taken are:

• To include Prop65 statement on label - WARNING: This product contains chemicals
known to the State of California to cause cancer and birth defects or other repro-
ductive harm

• Reformulation or lower recommendations (dosage) of the dietary supplement to
comply with required levels

• Stop selling the dietary supplement in California

Due to Prop65 requirements, Natura-Genics® has cancelled distribution of many of its dietary supplements in California while others, input recommendations have been reduced to comply with the law. The quality and ethical standards in the production of our dietary supplements have not being compromised.