Safety Concerns of Talc
Our Consultant Mailbox occasionally receives inquiries about the safety of the talc used in our Plum Flower™ teapills. This concern is due largely to the controversy about the decades-old lawsuit regarding talc-based body care powders including Johnson & Johnson’s® Baby Powder and Shower to Shower® (formerly a brand of J&J, but most recently Bausch Health Co.). The plaintiffs in these cases claim that the use of these products cause cancer, especially ovarian cancers in women. There is no conclusive evidence that talc causes cancer, but rather the culprit is likely asbestos, which is a known potential contaminant of talc. Since 2019 both Johnson & Johnson’s and Bausch have replaced talc with corn starch in their body care powders in the US.
Here at Mayway, we have an ongoing commitment to FDA (Food and Drug Administration) compliance and transparency, especially regarding disclosures and the labeling of our products. This is why talc appears on the labels of our Plum Flower ™, Bamboo Pharmacy™, and Min Shan® teapills. In sharp contrast to some other Chinese herb companies, we disclose every ingredient in our products including excipients and processing adjuncts. We should note here that it is not possible to make pills or tablets without the use of various excipients and that authentically produced Chinese herb formulas require herbs processed in the traditional ways, i.e., using páo zhì (炮制). Our use of talc within the manufacturing process is completely safe. Let us discuss this issue.
What is Talc?
Talc is a fairly common naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg3Si4O10(OH)2. Talc is formed from the metamorphism of magnesian minerals such as serpentine, pyroxene, amphibole, and olivine, although it also can be created by a combination of dolomite and silica or magnesium chlorite and quartz. As an example, soapstone is a metamorphic rock comprised predominantly of talc. Although it is mined on every continent (except Antarctica), the leading suppliers of talc are the US, China, Brazil, India, France, and Finland. Over twenty countries manufacture talc products for use in industrial, cosmetic, and pharmaceutical uses.
Talc is used in many industries, including paper making, plastics, paint and coatings, rubber, electric cables, and ceramics. A form of talc is used for stoves, sinks, and as part of the surfaces of laboratory tabletops, and electrical switchboards. Talc has many uses in cosmetics and other personal care products such as lipstick, mascara, toothpaste, and deodorants. For example, it may be used to astringe and absorb moisture and oils, to prevent caking, to make facial makeup opaque, or to improve the feel of a product.
The US FDA considers talc a “generally recognized as safe” (GRAS) food for use as an anticaking and whitening agent in food starch, starch mixtures, chocolates, baked goods, powdered dried fruits, rice, cheese, vanilla powder, seasoning, and table salt. Talc can be used as a whitening and polishing agent in the production of white rice from raw, brown rice. Historically, talc (along with glucose) was commonly found when purchasing white rice. In the 1970s and 80s, there were investigations into the possibility that talc-coated rice was responsible for the higher rates of stomach cancer in Japan. However, large, multi-center, multi-year studies in Japan, the Philippines, and Hawaii were unable to establish such a connection and other Asian rice-consuming populations do not exhibit similar incidents of stomach cancer.
In the pharmaceutical industry, talc is commonly used as an excipient as an anti-caking agent, a lubricant, and a glidant. Additionally, its anti-tacking property makes it desirable in enteric coatings for a variety of drugs. When used as a glidant, it is added to a powder to improve the powder’s flowability, usually just before compression into a tablet. Because of its hydrophobic nature, talc serves as an excellent lubricant when extruding semi-solid blends through extraction equipment, preventing the mixture from adhering to the surfaces of the equipment and to prevent agglomeration of pills after their formation into their final dosage form.
This last application of talc as a lubricant is the principal way that talc is used in the creation of Plum Flower™, Bamboo Pharmacy™, and Min Shan® teapills. It is not actually an ingredient, but a necessary excipient in the making of the pills. As previously noted, this is the reason that our US FDA compliant labeling includes talc. Some manufacturers use magnesium stearate (or other mineral stearates, which are salts derived from a long-chain fatty acid) as a glidant and binder, but in the production of teapills, stearates do not suffice as a lubricant or as an anti-agglomerant. Incidentally, as an excipient, corn starch is an unacceptable substitute for talc, because although it shares a drying and astringent property with talc, it cannot function as a binder, lubricant, or anti-agglomeration agent.
Talc is a Chinese Herb
Talcum is a Chinese herb known as Huá shí (滑石- literally “Slippery Rock”) belonging to the Herbs that Drain Dampness and Regulate Water category. The herb is Sweet, Bland, and Cold and enters the Stomach and Urinary Bladder. Its TCM functions include Clearing Heat, Clearing Summer-Heat, Draining Damp, and Promoting Urination. Topically, it is used to Clear Heat and Damp. Huá shí is an important Deputy Herb in several important classical formulas including Ba Zheng San, Fang Feng Tong Sheng San, and Xuan Bi Tang, among others.
But wait, doesn’t talc cause cancer?
First, no scientific study suggests that ingested talc causes any kind of cancer. Remember, the US FDA lists talc as a GRAS food. However, there have been legitimate concerns raised about the inhalation of talc. Long-term excessive inhalation exposure to talc, which may contain quartz, may cause talcosis (a form of silicosis), which is a type of pulmonary fibrosis, a disease that can lead to severe and permanent damage to the lungs. Based on the lack of data from human studies and limited data from animal studies, the International Agency for Research on Cancer (IARC- a part of WHO (World Health Organization)) has stated that inhaled talc not containing asbestos as “not classifiable as to carcinogenicity in humans.” Also, since comingling of talc with asbestos is quite possible, long-term inhalation of certain types of industrial talc may be implicated in mesothelioma.
Returning to the use of talc-based body powders and the possibility that these products cause ovarian or endometrial (uterine) cancer, even though juries have awarded compensation to plaintiffs, the science regarding talcum causing these cancers is mixed. The prevailing supposition is that the powder particles (applied to the genital area or on sanitary napkins, diaphragms, or condoms) travel through the vagina, to the uterus, and through the Fallopian tubes to the ovary. Some studies have reported a slightly increased risk and some report no increase. One of the problems with studying this issue is that even the largest studies might not have been big enough to detect a very small increase in risk, if it exists.
The role of asbestos
As mentioned earlier, the likelihood of asbestos contamination from mined talc is high, unless care is taken. In fact, it is the presumed presence of asbestos in talc-based body powder that is the main reason plaintiffs have won their cases, so far. (For a fascinating and startling article about the current status of these cases and J&J’s new strategy for dealing with liability, here is a link to The New Yorker magazine.)
Asbestos has been classified as a known human carcinogen by the U.S. Department of Health and Human Services, the U.S. Environmental Protection Agency, and the International Agency for Research on Cancer (IARC). According to IARC, there is sufficient evidence that asbestos causes mesothelioma (a relatively rare cancer of the thin membranes that line the chest and abdomen), and cancers of the lung, larynx, and ovary, and there is limited evidence that asbestos exposure is linked to increased risks of cancers of the stomach, pharynx, and colorectum.
From the 1970s, there was increasing concern about the dangers of asbestos, and its use was phased out, with mining having ceased in 1983. The removal of asbestos was begun in 1989 and banned entirely in December 2003. Currently, worldwide, sixty-six countries and territories have banned the use of asbestos for any purpose.
What is the association of Talc and Asbestos?
There are several types of asbestos minerals. Chrysotile (commonly known as white asbestos) represents the majority of asbestos used in industry and building construction. The other types are amosite (brown asbestos), crocidolite (blue asbestos), actinolite, anthophyllite, and tremolite, which constitutes a component of many if not all naturally occurring chrysotile deposits.
Talc can sometimes be contaminated with asbestos due to the natural proximity of asbestos ore (usually tremolite) in underground talc deposits. By 1973, US federal law required all talc products to be asbestos-free, and today there is strict quality control in the production of talc products. Stringent quality control since 1976, including separating cosmetic- and food-grade talc from "industrial"-grade talc, has largely eliminated this issue for consumers, but it remains a potential hazard requiring mitigation in the mining and processing of talc and careful quality control testing. A 2010 US FDA survey failed to find asbestos in a variety of talc-containing products. However, even though FDA has set regulations concerning talc, the consumer must always rely on the integrity of the companies producing talc-based/containing products to ensure that guidelines, proper testing methods, and protocols are followed.
How Does Mayway Ensure that its Talc is Asbestos-free?
Mayway imports Huá shí both as an herb and as an extract powder from its joint-venture processing facility in Anguo, Hebei, China, and the main supplier of our teapills, Lanzhou Foci uses Huá shí as an excipient (as described above). These talc products are strictly regulated by the Chinese National Medical Products Administration (NMPA formerly the China Food and Drug Administration) and are subjected to testing as defined in the 2020 Pharmacopeia of the People’s Republic of China using X-ray polycrystalline diffractometry. The minerals are tested for quartz, chlorite, and six types of asbestos including chrysotile, tremolite, actinolite, anthophyllite, crocidolite, and amosite with a zero (not detected) maximum tolerance. In addition, our talc products are tested for iron, lead, calcium, aluminum, and arsenic with strict limits of those elements, as well. Mayway Herbs can provide a Certificate of Analysis (CofA) for every product we sell, including our talc-containing herbs, and for each batch of talc used in the production of our teapills, upon request to Customer Service.
Talc is US FDA Generally Recognized As Safe (GRAS) and does not cause cancer when ingested. It is a Chinese herb that has been used in several important formulas for centuries. Mayway Herbs uses talc as a necessary excipient, and as such, it is present only in extremely small quantities. All the talc that is used in our products is tested to be free of asbestos (and other contaminants) using modern methods and technology. Our use of talc as an excipient in Plum Flower™, Bamboo Pharmacy™, and Min Shan® teapills should raise no safety concerns for you or your patients. Finally, to further separate our products from the negative associations in the minds of consumers about talc, we have chosen to begin listing talc using its scientific name “Hydrated magnesium silicate” on product labels of new batches.
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About the Author
|Skye Sturgeon is the Quality Assurance Manager and Special Consultant for Mayway, USA. Skye was the former Chair of Acupuncture & East Asian Medicine and core faculty member at Bastyr University, core faculty member and Faculty Council Chair at the American College of Traditional Chinese Medicine, and President and Senior Professor of the Acupuncture & Integrative Medicine College, Berkeley. Before making Chinese medicine his career choice, Skye held various positions in the Natural Foods Industry for 12 years and prior to that was a clinical biochemist and toxicologist.