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Herbal Products & Proposition 65 FAQ's
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Q: With a label that says "This product contains chemicals known to the State of California to cause cancer and/or birth defects or other reproductive harm," how can I believe the product is safe?
Q: How can I reassure my patients that your products are just as safe or safer than products which do not have the Prop 65 warning?
Q: If I consumed a typical herbal formula for a long period of time, even several years, would that increase my risk of cancer?
Q: Are there heavy metal differences between teapills, extract powders granules, tablets, capsules, and raw herbs?
Q: If it was originally passed in 1986, why has it taken Mayway all this time to label its products with the Prop 65 warning?
Q: Can't Mayway just filter out the heavy metals?
Q: Do you know whether US Pharmacopeia Standards are the standard used for the rest of the U.S.? (Could you ship Mayway products to other states without the warning?)
Q: Are your crude herbs tested for heavy metals, such as mercury, lead, etc? Are your crude herbs tested for chlorine, sulfites, bacteria, and fungus? If so, where do you get them tested?
Q: To clarify the information in your Prop. 65 brochure regarding Prop 65 standards compared to the standards you are using, it would be helpful if you translated NSRL (No Significant Risk Levels for cancer) to your standards (as you did in the Frequently Asked Questions section, in regard to Lead). The information as it exists leaves me wondering what the difference is between "Prop 65's more stringent standards", and the standards you use.
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Q: With a label that says "This product contains chemicals known to the State of California to cause cancer and/or birth defects or other reproductive harm," how can I believe the product is safe?
A: Mayway has consistently tested its products for the presence of heavy metals for years, specifically lead, arsenic, mercury and cadmium. We have been vigilant in requiring that our products meet the heavy metal standards of the U.S. Pharmacopoeia and the Australian Therapeutic Goods Administration for medicines of botanical origin. However, some products do exceed Prop. 65 notice requirement levels and will therefore need to post the Prop 65 warning when sold in the state of California. Mayway will continue to reject batches of Plum Flower® and Min Shan® Brand products if heavy metals exceed Company standards, regardless of warnings.
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Q: How can I reassure my patients that your products are just as safe or safer than products which do not have the Prop 65 warning?
A: The irony and danger of selective and gradual enforcement is that there will be products on the market that don't yet contain warnings, even though those products may not only have heavy metal concentrations in excess of Prop 65 standards, but may be in excess of the standards adhered to by Mayway. It is possible and perhaps likely that herbal products that carry the Proposition 65 warning are actually safer than products that don't. As such, it is important that you are aware of the standards of individual companies and brands.
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Q: If I consumed a typical herbal formula for a long period of time, even several years, would that increase my risk of cancer?
A: No. As an example, our maximum allowable limit for lead is 3 ppm. Most of our products have a much lower lead content, usually less than 1 ppm. Even at 3 ppm, the total amount of daily exposure to lead would be 13.32 micrograms (based on the average daily dosage of 8 pills 3 times per day.) The "No Significant Risk Level" (NSRL) for lead is 18 micrograms per day. Again, this means that even at 18 micrograms per day, taking the formula every day for 70 years would increase your chances of getting cancer by no more than 0.00001%. Also note that the average adult only absorbs 5-15% of the heavy metals they ingest, so the term daily exposure means just that, exposure, and not absorption. However, it is important to remember that our company standards are for our products, and that there are no established standards for our industry. As such, it would be advisable that you check with individual companies for their standards and whether they have each batch tested.
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Q: Are there heavy metal differences between teapills, extract powders granules, tablets, capsules, and raw herbs?
A: Yes, but not particularly due to the form of the product. Heavy metal content in the same product can vary from batch to batch due to a variety of factors including the type of herb, the part used, the environment and condition of the soil and water in which it was grown, the individual harvest, and the cleanliness of the herb (e.g. soil residues contain heavy metals.) Although concentrating an herb tends to concentrate the amount of heavy metals just as it concentrates the active ingredients, the resulting levels of heavy metals in a finished product depends almost entirely on the condition and quality of the raw herbs that are used.
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Q: If it was originally passed in 1986, why has it taken Mayway all this time to label its products with the Prop 65 warning?
A: Although the statute was passed in 1986, there was no proactive enforcement or action on the part of the government to inform businesses of their legal requirements in regards to Proposition 65. The proposition has relied on selective and gradual enforcement by independent entities with an economic incentive to proceed with legal action. Because there are no state or federal guidelines for heavy metal levels in traditional Chinese medicines, Mayway believed that it was being proactive and responsible by adopting and adhering to the standards of the U.S. Pharmacopoeia and Australian Therapeutic Goods Administration. We only recently became aware of Proposition 65 and its applications to our industry. While we believe that there are some problems with Prop. 65, such as its selective enforcement and its unrealistic heavy metal levels when applied to botanical products, we also recognize that Prop 65 is the law. We also support the idea that practitioners and patients/ consumers have the right to be informed about what they prescribe and ingest, and so we will provide the Prop 65 warning on all of our products for which we do not have test data confirming that lead, arsenic, and mercury levels are below Prop 65 notice requirement levels.
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Q: Can't Mayway just filter out the heavy metals?
A: Plants absorb heavy metals as they grow. Heavy metals become incorporated into the plant's cells, and tend to leach out of the plant along with other plant molecules during the cooking process. Individual heavy metals can be removed using processes similar to those that are used to filter drinking water, but due to the size of the particles, active components in the extracted liquid would most likely be removed along with the heavy metals. In the end, the filtered liquid may not be much more than filtered water.
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Q: Do you know whether US Pharmacopeia Standards are the standard used for the rest of the U.S.? (Could you ship Mayway products to other states without the warning?)
A: It is very important that everyone be made aware that at this time there are absolutely no federal heavy metal guidelines in place for traditional Chinese medicinal herbs. The FDA considers Chinese herbs and medicine as dietary supplements, which are considered as food. There are only set guidelines for certain types of food, such as meat, or canned food. Most vegetables and fruits do not have specific guidelines unless they are usually subject to high amouts of pesticides and other agricultural chemicals. As traditional Chinese medicinal herbs are considered food, the FDA believes that there should be absolutely no harm or side effects from eating even huge quantities. This not only takes away from the respect TCM should have as medicine, but fails to serve or protect the profession and the general public.
Please remember that Mayway as a company, not traditional Chinese medicine as an industry, sought out standards as there were and are none in place. U.S. Pharmacopoeia levels for medicines of botanical origin are lead 10 ppm, and mercury, cadmium, and arsenic at 3 ppm. We chose to adhere to the limits of the Australian TGA (Australia's equivalent to the FDA) because they were slightly more stringent with lead at 5ppm, and mercury, cadmium, and arsenic at 3 ppm. We have tested each batch of our Plum Flower® and Min Shan® brand products using these guidelines for the past five years. We have found through years of testing that heavy metal limits can be controlled through herb selection and thoughtful processing and manufacturing, and our products usually test out much lower than these numbers.
We chose to hold ourselves to these standards to implement a level of safety and quality control, not because the FDA required it of our company or our industry. In fact, as imported products, our products and herbs are at least subject to FDA inspection and sampling, whereas most U.S. made herbal products are not.
Other industries, most notably the pharmaceutical industry, have FDA guidelines and are thus not subject to Prop. 65. The U.S. Pharmacopoeia's limits pertain in general to botanically based (as opposed to synthetically produced) medicines, and are much less stringent than Prop. 65. This is because the USP and the FDA believe the USP's standards to be safe and reasonable. The fact that the FDA believe the USP's standards to be safe and reasonable is a major reason why no other state, or the federal government, has ever written the Prop. 65 standards into law.
As there are no federal standards for TCM or dietary supplements, and Prop. 65 is not the law in any other state than California, there are no restrictions or labeling required for products sold to or in other states.
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Q: Are your crude herbs tested for heavy metals, such as mercury, lead, etc? Are your crude herbs tested for chlorine, sulfites, bacteria, and fungus? If so, where do you get them tested?
A: Our Plum Flower® Brand raw herbs are processed at our own joint-venture facility in China. Each season herbs arrive fresh or unprocessed, and are identified, tested for sulfur, cleaned, processed, and dried. After drying, the herbs are tested for Standard Plate Count (aerobic bacteria), mold, yeast, coliforms, and salmonella. These tests are all done in house.
We used to test for total heavy metal content based on lead, but now we test for lead, arsenic, mercury, and cadmium separately. We do not use nor test for chlorine or aluminum phosphates as we control the processing and packaging of our herbs from start to finish. Our vacuum-sealed inner bag and nitrogen injected outer bag packaging is the only way we preserve our herbs. We also began testing for DDT and Benzene Hexachloride residues, pesticides that were once used but are now banned both in China and the U.S. The Hebei Province Product Import-Export Bureau, a government agency, conducts these tests.
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Q: To clarify the information in your Prop. 65 brochure regarding Prop 65 standards compared to the standards you are using, it would be helpful if you translated NSRL (No Significant Risk Levels for cancer) to your standards (as you did in the Frequently Asked Questions section, in regard to Lead). The information as it exists leaves me wondering what the difference is between "Prop 65's more stringent standards", and the standards you use.
A: The levels established in Prop. 65 are extremely stringent (see our Prop. 65 brochure section of "What are Proposition 65's Standards?"). NSRL (No Significant Risk Levels for cancer) and NOEL (No Observable Effect Level for reproductive harm) levels that have been established by the OEHHA (Office of Environmental Health Hazard Assessment) in Sacramento are as follows:
| Lead |
NSRL: not yet established but a high priority this year
NOEL: 0.5 micrograms/day |
| Arsenic |
NSRL: 10 micrograms/day
NOEL: not yet established but a high priority this year |
| Mercury |
NSRL: not yet established but a low priority(3-4 years)
NOEL: not yet established but a low priority(3-4 years) |
| Cadmium |
NSRL: not considered a carcinogen (by oral route) by the IARC (International Agency for Research on Cancer)
NOEL: not yet established |
Although many of these limits have not yet been established, please remember that the NSRL levels are based on taking in heavy metals at the these amounts everyday for 70 years and still increasing your chances of cancer by only a miniscule amount (0.00001%), and that the NOEL levels are one one-thousandths of the level that may cause reproductive harm.
By working with experts in the field, we have been able to estimate the amounts of each heavy metal that would be at those NSRL and NOEL limits. We have come up with daily exposure (daily intake) limits as follows:
| Lead |
NSRL: 18 micrograms/day
NOEL: 0.5 micrograms/day |
| Arsenic |
NSRL: 10 micrograms/day |
| Mercury |
NOEL: 0.25 micrograms/day |
| Cadmium |
NSRL: 6 micrograms/day |
As the NOEL limits for reproductive harm (again one one-thousandths of what might cause reproductive harm) are so low, we are unable to be under the limits that would permit us to remove the warning label. However the levels of heavy metals in our products are still only a fraction of what actually may cause reproductive harm. As the NOEL level for Lead is 0.5 micrograms/day and represents one one-thousandths of what may cause harm, that means that in reality it is the daily intake of 500 micrograms of lead that may actually cause harm. At our former limits, the daily exposure to lead if it were at our maximum of 5 ppm would have been about 22 micrograms (based on 24 pills per day). This would still be 22 times less than what might cause harm. At our old mercury level of 3 ppm, it would be 38 times less. All in all, this means that someone would have to take over 500 pills a day to even get close to the level that may cause reproductive harm.
Because of these calculations, we lowered our company heavy metal limits in July 2001 to lead at 3 ppm, arsenic at 2 ppm, mercury at 0.5 ppm, and cadmium at 1 ppm. At our new heavy metal levels, all batches produced in July 2001 and thereafter would be below the NSRL cancer limits that would require a cancer warning.
A recent retesting of current batches of 30 of our most popular Plum Flower® Brand products showed that 27 of the 30 had lead levels under 2 ppm, 20 had arsenic levels under 1 ppm, all 30 had cadmium levels under 1 ppm, and 28 had mercury levels of under 1 ppm. In reality, even at our old heavy metal limits, only 2 would have required the cancer warning. However, as we are still legally liable for any and all of the products we sell, we put the generic Prop. 65 label on all of our products. We hope to eventually go to court to petition for the label change to remove the cancer warning when every batch of all of our products have been brought in line with our new standards. This is a lengthy process, but one that we are committed to seeing through.
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For further questions about our products and Prop 65,
please call us at (510) 208-3113, or email us at prop65@mayway.com.
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