California Prop 65

WARNING: Reproductive Harm – www.P65Warnings.ca.gov

We appreciate your concerns about the California Proposition 65 warnings seen on some of our invoices and product labels. Rest assured our products continue to be safe. The warning has been added to ensure compliance with Proposition 65 so that we can continue serving our customers in California.

The chemical in question is lead, an element that can be found commonly or naturally in soil, plants, and water. Banyan’s products are made from dried whole herbs grown in nature. Banyan does not intentionally add any lead to any of its products.

The State of California requires a warning for any product sold in California that would result in a consumer ingesting more than 0.5 micrograms of lead in a day. This is an exceedingly low level that is, by law, 1000 times lower than the level of exposure that has been shown to have no observable effect on humans or animals. Therefore, the law sets an extremely stringent warning threshold.

Many herbs contain very low levels of lead that may trigger the requirement to warn. Rather than limiting our customers’ access to whole herb products in California, we have chosen to issue the warning specified under Proposition 65.

All of our herbs and products test well within the internationally accepted safety standards for dietary supplements (ANSI 173). If you would like to read more about Banyan’s stringent safety standards and testing, please see the FAQs below.

FAQ’s: Heavy Metals and Prop 65

Are Banyan products safe?

Yes, our products are well within the safety levels set by the internationally recognized standard for dietary supplements—ANSI 173.

Are Banyan herbs tested for heavy metals?

Yes, often multiple times. For herbs sourced overseas, before the herbs are ever shipped to us from their point of origin, they are tested for heavy metal levels. Regardless of the country of origin, when the herbs arrive at our warehouse, they are quarantined and again tested for a number of things, including heavy metals. Only if the herbs pass ANSI 173 specifications are they released into inventory to be made into formulations and tablets. Once the herbs are in a finished tablet form, the tablets are again tested for heavy metals, and only when they pass this rigorous examination are they released for sale.

How are Banyan herbs tested for heavy metals?

Banyan herbs are tested at reputable, independent laboratories in the UK and USA. Our labs use the ICP-MS method (inductively coupled plasma/mass spectroscopy), one of the most reliable methods available.

What safety standards does Banyan use?

As explained in our Quality Control Statement, we make sure all of our products pass the ANSI 173 safety guidelines for heavy metals, as set by the National Sanitation Foundation/American National Standards Institute. In setting their standards, the NSF took into consideration regulatory values and guidelines from around the world, including the U.S. EPA, Health Canada, Australia/New Zealand, Food and Agricultural Organization (FAO), World Health Organization (WHO), U.S. FDA, ATSDR, European Agency for the Evaluation of Medicinal Products, International Pharmacopoeia, Expanded Commission E Monographs, U.S. Pharmacopoeia, European Pharmacopoeia, American Herbal Pharmacopoeia, British Pharmacopoeia and California EPA Proposition 65.

If Banyan products are safe, why is there a warning about possible reproductive harm?

The State of California has a law called Proposition 65 (also known as the Safe Drinking Water and Toxic Enforcement Act of 1986), which requires the state to publish and maintain a list of 800+ chemicals, including heavy metals, known to cause cancer, or birth defects or other reproductive harm. Prop 65 also requires businesses to notify Californians about the presence of these chemicals in their products if the chemicals exceed certain levels.

How were Prop 65 levels for a warning determined?

The levels set by Prop 65 at which a warning must be provided are very stringent. For listed chemicals that are reproductive toxicants, such as lead, the level triggering a warning is, by law, 1000 times lower than the highest level of lead known by California NOT to cause reproductive harm. In other words, the Prop 65 warning threshold for lead incorporates a 1000-fold safety factor below the level found to have no observable effect on humans or animals. For lead, a warning is required at levels above 0.5 mcg/day, which is very stringent.

Banyan’s products follow the ANSI 173 safety standards, which require that products have less than 20 mcg/day; so all of our products, even when taken at the maximum amount suggested on our label, are below 20 mcg/day. Rather than limiting our customers’ access to whole herb products in California, we have chosen to issue the warning specified under Proposition 65. Again, Banyan products are nowhere near the no observable effect level as established by the very science on which Prop 65 is based.

How do Prop 65 levels compare with other safety standards?

Various countries and safety organizations have reviewed known studies and science to produce safety guidelines on the levels of heavy metals that can be consumed on a daily basis without causing harm. The Prop 65 levels are among the most stringent, and again, build in a 1000-fold safety factor below the no observable effect level for chemicals listed as reproductive toxicants. For comparison, where Prop 65 allows for 0.5 mcg/day of lead, according to the AHPA, Canada’s Natural Health Directorate allows for 20 mcg/day, the FAO/WHO and EU allow for 250 mcg/day, the US FDA Tolerable Daily intake is 75 mcg/day, and the ANSI 173 standard (which Banyan follows) is 20 mcg/day.

Do you put lead in your products?

No. Banyan does not intentionally add lead to any products. There is an esoteric class of Ayurvedic medicines that uses metals for healing called Rasa Shastra, but Banyan does not produce or carry these types of products. In some cases, Rasa Shastra based products have contained thousands of times more lead than would be found in a pure herbal product. These products are generally manufactured in India and brought to the U.S. illegally and have been a major factor in the confusion surrounding the safety of Ayurvedic herbs.

Lead is an element that exists in nature. It is found in varying degrees across the globe. Lead is widely distributed in the environment and may be found naturally in the earth, soil, and water as a result of geologic deposits of lead. Plants grown in soils containing lead can uptake lead into parts of the plants. Another source of lead in the environment has been through human activities such as the use of leaded gasoline.

Why don’t I see this warning on other products?

Hundreds of companies have received Prop 65 notices regarding lead in nutritional supplements, including reputable big name brands. Many of the legal battles are ongoing. Some companies are pulling products from the shelves, some are reformulating where possible, some are moving to extracts, some are decreasing the suggested usage, and some are negotiating settlements that allow for higher levels of lead without the warning. Some companies are also providing Prop 65 warnings for their products.

Is anyone exempt from putting the warning?

The Prop 65 law has allowed for some exemptions:

• Companies with less than 10 employees do not have to warn, regardless of levels of chemicals.
• Companies that can prove that heavy metals are “naturally occurring” do not need to warn for exposures to those naturally occurring levels. Proving that lead is naturally occurring can require litigation.
• Some companies have negotiated Court-approved settlements that provide additional, “naturally occurring” allowances for lead in dietary supplements. Those companies do not need to provide warnings if their products do not exceed those allowances.
• Prescription drugs are exempt from the Prop 65 warning requirements.

Why did you decide to put the warning on the label?

Our aim is to provide you with the safest, most efficacious whole herb products available. We decided to place the warning on the bottle because the alternatives did not seem to serve you, our customer.

• Making changes to the formula or lowering the amount to be taken daily would make the products less effective.
• We did not want to remove our products from California as an alternative. Our mission is to make available the healing properties of whole herbs to all those who choose to use them in their health care, and making our products unavailable to Californians runs contrary to our mission of service. We believe it is the right of every person, including Californians, to be able to take safe herbal medicines in the form of their choosing.
• We strive to protect and retain your access to whole herbs (as opposed to extracts and “active ingredients”). Using the powders made from the whole parts of dried plants is a traditional way of taking Ayurvedic herbs. It is the way we were taught by our teachers and the way their teachers taught them going back thousands of years. Extracts certainly have a place in herbal medicine, but we believe nature’s wisdom to be superior to human manipulation. Ayurveda firmly believes in the intelligence of the entire plant, of ALL of the plant’s components, not just the “active ingredient” as determined by a lab. There are still many aspects of herbal healing that are not fully understood by Western scientists. The great healing traditions of the East do not necessarily lend themselves to the rigid confines of the currently accepted paradigm.

We hope that this information has helped you make an informed decision. We strive to bring you the healing power of the whole herb, in a natural form that is convenient to use. We do this in coordination with an effort to bring you safe and effective herbs that are certified organically grown and sustainably sourced.