Download this page in PDF formatA couple of years ago I noticed that Golden Flower Chinese Herbs was promoting Yin Care “Effective” Herbal Wash to treat “STD’s” with a flyer in orders I got from them. Yin Care Wash is distributed by Arbor International and is made in China. It struck me as irresponsible at the time, but I ignored it and hoped it would go away. But alas, it has become more popular and is even available on Amazon.com.
Here is their summary, provided on their main website:
JIE ER YIN XI YE = CLEAN YOUR YIN WASH LIQUID
Dry and transform dampness, clear heat and toxin, purge fire, cool blood, disperse wind and stop itching, reduce swelling, detoxify skin lesions, promote circulation. Use at varying concentrations both topically and intravaginally for dampness, damp-heat, toxic-heat and wind gynecological patterns with or with out discharge including leucorrhea, vaginitis, cervicitis, gonorrhea, vulvovaginitis, S.T.D.’s, as well as general inflammations, infections and itching. Also used for various damp-heat, wind-damp and heat dermatological patterns such as psoriasis and eczema, shingles, rashes, cold sores, fungal foot afflictions, styes and acne. In small concentrations and applied as a compress to facilitate the healing of burns.
The “Yin” here is a reference to the genitals, particularly the vagina.
It is very clear that they are promoting this for treating gonorrhea and “S.T.D.’s” by topical and intravaginal application. They sell a special vaginal applicator for it:
I called Arbor today to ask them some specific questions about their product:
“Hi, I’m an acupuncturist in Oregon considering prescribing Yin Care in my clinic, but have some questions about it first, is there someone I should talk to who knows most about the ingredients and manufacturing?” The employee answered “You can try me first!”
I asked, “I see there are no preservatives listed, including alcohol. Does it have preservatives?”
The friendly woman who answered the phone said “I don’t think so” but chose to pass me on to someone else. She returned and took my number and said they would call me back in 10 minutes. Eva, the business partner of the acupuncturist Daniel who started importing and marketing it called me back.
Does it have preservatives?
Eva: No alcohol, it has disodium laureth sulfosuccinate as emulsifier & potassium sorbate as preservative.
[I finally found where this is listed on their website along with the herbal ingredients.]
Does this need refrigerating after opening?
No, it doesn’t.
How long is it good for after opening?
How are out is the expiration date?
What is the shelf life?
Eva: 2015 for the current batch. I have no reservations about telling you or patients to use it years after expiration.
I see your site recommends it for gonorrhea and S.T.D.’s. Are there some it’s better for than others, or some sexually transmitted diseases it’s not good for?
Eva: I’m not a practitioner, but I wouldn’t say there’s any condition that would benefit more or less.
Then Eva went on to say that even if you don’t know what sort of infection someone has, as long as they have the symptoms of burning, itching, or discharge, you can give them Yin Care and it often makes them go away.
It seems that this is a topical drug product, not a dietary supplement. Is it approved in the US as a topical drug product?
Eva: ”No, as there are no drugs in it. It’s a cosmetic. It’s considered a soap, a pathogenic body wash.”
What is your internet resale policy? I see I can order Yin Care on Amazon. Is that OK with your company?
Eva: It’s OK, we have no resale policy, as there are 12 distributors and it would be hard to police them.
Eva then said she often gets asked about the fragrance vs. no fragrance options. When I asked her if the fragrance was synthetic she said “The fragrance is a propriety blend of synthetic and essential oil.” [Note their site says the fragrance is all natural http://www.yincare.com/glossary.htm.]
I thanked her for her time and answers.
YinCare.com provides some abstracts which lack some detail and have some questionable conclusions, which is typical for Chinese research.
Please note that the conclusion is that it has 93.5% effectiveness. This includes three categories: cured, very effective, and effective. For “N. Gonorrhea” it is noted that there was a 45.7% effectiveness rate. Gonorrhea makes it on the main list of recommended uses for Yin Care. Pardon me, but if gonorrhea isn’t cured totally, I believe it can still be transmitted and come back (actually, it can often become asymptomatic, but lead to dead or blind babies). How can there be a ‘not cured but very effective’ category for sexually transmitted diseases? Additionally, there is no info on follow-ups. So it is possible it reduced the symptoms for a week or so but didn’t cure the disease, and that 6 months or a year later there was a complete recurrence of symptoms (while in the mean time the STD can be transmitted to many other people).
The next study looks at chlamydia and claims that out of the 40 cases of men and women with chlamydia 39 out of 40 were cured. My concerns about chlamydia being treated in the clinic by acupuncturists who cannot do tests to determine if it is really gone are what made me want to write about this in the first place. As the CDC says:
Chlamydia is known as a “silent” disease because the majority of infected people have no symptoms. If symptoms do occur, they usually appear within 1 to 3 weeks after exposure.
In women, the bacteria initially infect the cervix and the urethra (urine canal). Women who have symptoms might have an abnormal vaginal discharge or a burning sensation when urinating. If the infection spreads from the cervix to the fallopian tubes (tubes that carry fertilized eggs from the ovaries to the uterus), some women still have no signs or symptoms; others have lower abdominal pain, low back pain, nausea, fever, pain during intercourse, or bleeding between menstrual periods. Chlamydial infection of the cervix can spread to the rectum.
…
What complications can result from untreated chlamydia?
If untreated, chlamydial infections can progress to serious reproductive and other health problems with both short-term and long-term consequences. Like the disease itself, the damage that chlamydia causes is often “silent.”
In women, untreated infection can spread into the uterus or fallopian tubes and cause pelvic inflammatory disease (PID). This happens in about 10 to 15 percent of women with untreated chlamydia. Chlamydia can also cause fallopian tube infection without any symptoms. PID and “silent” infection in the upper genital tract can cause permanent damage to the fallopian tubes, uterus, and surrounding tissues. The damage can lead to chronic pelvic pain, infertility, and potentially fatal ectopic pregnancy (pregnancy outside the uterus). Chlamydia may also increase the chances of becoming infected with HIV, if exposed.
…
What is the treatment for chlamydia?
Chlamydia can be easily treated and cured with antibiotics. A single dose of azithromycin or a week of doxycycline (twice daily) are the most commonly used treatments. HIV-positive persons with chlamydia should receive the same treatment as those who are HIV negative.
All sex partners should be evaluated, tested, and treated. Persons with chlamydia should abstain from sexual intercourse for 7 days after single dose antibiotics or until completion of a 7-day course of antibiotics, to prevent spreading the infection to partners.
Women whose sex partners have not been appropriately treated are at high risk for re-infection. Having multiple infections increases a woman’s risk of serious reproductive health complications, including infertility. Women and men with chlamydia should be retested about three months after treatment of an initial infection, regardless of whether they believe that their sex partners were treated.
We see here that many people with chlamydia have no symptoms, or they have symptoms that go away while the disease is still causing internal damage and being passed on. Damage that can come from improper or incomplete treatment of chlamydia includes a miscarriage, a baby born blind, or infertility. Transmitting the disease to others of course is also a risk, even if there are no symptoms.
Many acupuncturists are trained to think that they are curing disease at a deeper level than a Western Medicine doctor. So if a woman has symptoms of itching and burning in the vagina, and they give them some herbs which “Clear Heat” and then those symptoms go away, they will pronounce the patient cured. Since most acupuncturists don’t have a scope of practice which includes ordering blood tests from a lab, they cannot do testing to see if there is an STD present, or if the STD has actually been cured. With chlamydia, all sexual partners also need diagnosis and treatment to prevent reinfection.
If a woman has discharge and burning, but doesn’t want to go to an MD for a test, but goes to an acupuncturist who recommends Yin Care, has that acupuncturist done them a favor if the symptoms go away and the acupuncturist pronounces them cured? If the attitude of the acupuncturist is “Yin Care is so good at treating almost every type of vaginal infection that we don’t even need to test you to see what kind of infection it is” and then later the woman has a miscarriage, baby born blind, or is made sterile by the “silent infection”, whose fault is that?
If the woman goes to an MD who tests her for chlamydia and she is positive, and the approved therapy is one dose of azithromycin, would it serve the woman better to refuse this treatment and try Yin Care instead? What acupuncturist would think of recommending such a course of action if they hadn’t been influenced by the marketing materials of Arbor International? What MD or pharmacist would think that was a good idea?
YinCare.com also has an abstract on gonorrhea. It is important to note that the Yin Care group in this study also took oral cefalexin, but a higher cure rate was reported than the control group on oral cefalexin and other medicines. Study author bias, the lack of double-blind controls, or outright fabrication of the research (there’s just one article on Pubmed in Bulgarian) are unknown factors in the conclusions as well. But in the marketing materials on yincare.com, amazon.com, and other sites, it clearly says that Yin Care is an Effective Herbal Wash and is promoted to treat gonorrhea & the vague category of “S.T.D.’s”.
What does the FDA say about Soaps and Pathogenic Body Washes?
The claim by Eva that Yin Care is a cosmetic/soap and not a drug does not hold up to the clear rules the FDA has.
On a page titled: Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) the FDA writes:
The legal difference between a cosmetic and a drug is determined by a product’s intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.
How does the law define a cosmetic?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
How does the law define a drug?
The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].
How can a product be both a cosmetic and a drug?
Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.
…
And what if it’s “soap”?
Soap is a category that needs special explanation. That’s because the regulatory definition of “soap” is different from the way in which people commonly use the word. Products that meet the definition of “soap” are exempt from the provisions of the FD&C Act because — even though Section 201(i)(1) of the act includes “articles…for cleansing” in the definition of a cosmetic — Section 201(i)(2) excludes soap from the definition of a cosmetic.
How FDA defines “soap”
Not every product marketed as soap meets FDA’s definition of the term. FDA interprets the term “soap” to apply only when –
- The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
- The product is labeled, sold, and represented solely as soap [21 CFR 701.20].
If a cleanser does not meet all of these criteria…
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:
If a product –
- consists of detergents or
- primarily of alkali salts of fatty acids and
- is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
it is regulated as a cosmetic.
If a product –
- consists of detergents or
- primarily of alkali salts of fatty acids and
- is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
it is regulated as a drug.
If a product –
- is intended solely for cleansing the human body and
- has the characteristics consumers generally associate with soap,
- does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic.
That’s pretty clear, isn’t it? Only if Yin Care were “labeled, sold, and represented solely as soap” would it be fall under the soap rules. Since the importer and distributors clearly market it for treating serious diseases, it is a drug. I couldn’t find the word ‘soap’ in any description of Yin Care. Even if it were simply a shampoo claiming to help dandruff, it would be a drug. But since it is promoted to treat serious, transmittable diseases such as gonorrhea and chlamydia, it is clearly an unapproved new drug which needs to go through the drug approval process prior to marketing in the US and presents a true public health hazard. Failing to effectively treat dandruff is one thing…
Now that we know that Arbor International is either ignorant or lying (I vote for the latter, and you?) about their awareness of the categories of soaps, cosmetics, and topical drugs, can we trust them on anything else? Their site says that the fragrance is natural, but Eva told me it is a mix of synthetic fragrance and essential oils. Remember the melamine poisoning that killed so many pets after it was put into pet foods but not disclosed on the ingredients? Would you be surprised if Yin Care was found to have unlisted pharmaceutical drugs in it? Or other contaminants like industrial solvents or harsher preservatives? This makes Yin Care qualify as a fraud and scam in my book. I wouldn’t put it on my shelf, much less my private parts.
Any acupuncturist who is willfully ignorant enough to recommend Yin Care to any patient with undiagnosed vaginal burning and discharge is risking their reputation, their license, and their patient’s health and best interest. Any distributor who reads this article and doesn’t immediately stop distributing it is consciously participating in an illegal drug smuggling operation which could kill or blind babies.
If Arbor International doesn’t stop importing Yin Care and introducing it to interstate commerce in the US until they have it approved as a topical drug product, they are continuing their corrupt criminal behavior that will continue to damage the TCM profession. They are asking for a strong FDA action to shut them down, and the ramifications on the reputation of the Traditional Chinese Medicine industry, which are already on shaky ground, will be severe. If Arbor, Daniel, and Eva care about TCM and acupuncturists, they can have no other response to my pointing this out than to voluntarily remove Yin Care “Effective” Herbal Wash from the market immediately. They have one chance to plead ignorant innocence, and they had better do it quickly and convincingly. It really should be recalled from everyone who it’s been sold to, as that would be the most responsible action to protect acupuncturists and their patients.
The only way this formulation would be legal and ethical is if a licensed practitioner made it out of the bulk herbs in their own state for use in their own clinic. But since this formula doesn’t appear in any approved TCM text that I know of that would be unlikely. It also leaves the question open of whether it’s appropriate to attempt to treat something that could be an STD with this sort of thing. If any fans of Yin Care are concerned that my writing about this will make it so they can’t get it, they could still get the bulk herbs and make it themselves (in small batches, boiled in pure water with no preservatives, used within a day or two and kept in the fridge). If it doesn’t work as well this way, it again raises the question of what’s really in the bottle.
Once again, I feel like I may be able to save lives and save acupuncturists from terrible consequences if my writing can reach them. Please comment, share this link, and let me know if you see any errors or holes in my presentation of this matter. If I have helped you make a different decision about the use of this or a similar product, please let me know. As far as I can tell, no one else has written anything critical of Yin Care–everyone who knows about it is apparently just trying to make a buck by promoting it. I didn’t get into Traditional Chinese Medicine with the intention of being one of the only whistle-blowers from inside the industry, but I appear to be in that role now, and I’m going to do the best job I can for the benefit of all of my readers.
Thanks for reading–please subscribe to my blog (just enter your e-mail at the top right of any blog page at http://www.ancientway.com/blog) and Twitter feed to get instant notification of my postings.
Sincerely,
Kevin O’Neil, L.Ac.
Update: I see that a couple people have found this post while searching for ‘natural cures for gonorrhea’ and ‘herbs for chlamydia’ etc. Also, before I wrote this, the only Google results for Yin Care Herb Wash were people trying to sell it (I didn’t see any critical Yin Care reviews), but now this post is one of the front page hits for Yin Care. This encourages me to keep writing honest, informative, critical reviews of fraudulent and suspect Chinese herbal products. Please let me know if I have helped you (or if you disagree and think I’m a jerk for pointing out these things).
—
Here is a screenshot from YinCare.com in case it disappears soon:
The following is from one distributor’s website, here as an example for how distributors just cut and paste info from the manufacturers, which is why the manufacturer’s marketing materials are considered part of the product labelling when they introduce products into the United States.
| 4 fl. oz. (116 ml.) For External Use.Yin-Care has earned the rare distinction of being one of those remedies highly-prized by healthcare professionals universally and has been used by millions of people over these last 20 years with remarkable effectiveness.It is a combination of 14 highly concentrated herbs treasured, for centuries in China, for their anti-pathogenic properties. Because it’s an easy to use wash and highly versatile, it is wonderfully effective for a wide range of conditions.Ingredients: She Chuang Zhi, Jin Yin Hua, Huang Bai, Huang Qin, Yin Chen Hao, Cang Zhu, Tu Jing Pi, Bo He, Zhi Zi, Ku Shen, Di Fu Zi, Du Huo, Shi Chang Pu, Ai Ye. |
|
| In modern, biomedical terms, Yin-Care has been formulated primarily for external use in the treatment of topical and gynecological infections due to viral, bacterial, fungal or yeast-type microbial pathogens.In the terminology of Traditional Chinese Medicine (TCM), Yin-Care is designed for use in the treatment of damp, damp-heat, toxic heat, and wind-type pathogenic factors. This means Yin-Care can be applied to women’s problems ranging from common yeast infections to STD’s and for skin conditions ranging from common acne and athlete’s foot to psoriasis and shingles.Indications: Yeast Infections, Bacteria, Cold Sores, Acne, Eczema, Psoriasis, Shingles, Rashes, Poison Oak, Poison Ivy, Minor Cuts, Bug Bites, Nail Fungus, Athlete’s Foot.Dosage: Topically: Mix (5-100%) herbal concentrate with various amounts of water into a solution, apply directly to skin as a wash, compress or sitz bath 2-3x day.Vaginally: Utilize washing receptacle (douche) and mix 5-20% concentrate with water, rinse 2-3x day, 5-6 days a course of treatment. For more serious vaginal conditions, soak tampon with 50% concentration mixture and insert for 3-5 hours 1-2x day, 6 days as course of treatment. |
Dear Eva and Daniel,
After speaking to Eva yesterday and reviewing the details of the Yin Care site, I am very disturbed and concerned by your marketing approach. Eva told me you consider YIn Care to be a soap or cosmetic, yet you clearly are marketing it to acupuncturists (and the general public) as an effective treatment for serious diseases such as gonorrhea and chlamydia. This clearly makes it a drug according to US law. I think there is a 1% chance you’re ignorant of the laws regarding soap/cosmetic/food/drug, and a 99% chance that you’re intentionally engaging in fraudulent marketing of an illegal drug (even if you believe that you are helping people by doing so).
Since I find this to be a danger to the TCM community as a whole and anyone who chooses to self-treat an STD after reading your marketing materials, I have chosen to write about these issues on my blog. I feel I may be able to help protect acupuncturists and patients from being harmed by your deceptive marketing.
Because I do my best to be accurate, honest, and honorable, I am willing to have a written discussion with you about how you are marketing Yin Care. If you change my mind, and can convince me that it is a safe, effective, and legal product, I will gladly retract my blog post or correct any inaccuracies you find in it.
Here is my link: http://ancientway.com/blog/?p=649
Please note that I’m only willing to discuss this with you in writing (e-mail preferred), and I may quote or use anything you write to me in my public discussions of these issues.
I am serious about recommending that you withdraw Yin Care from the market at once. If that is disagreeable to you, my next recommendation would be that you remove all references to STDs from your site and the material you provide to your distributors. I suspect you already know you are on very thin ice and are inviting a harsh FDA action which would embarass and harm our entire industry.
Sincerely,
Kevin O’Neil, L.Ac.
I just received a response from Yin Care:
Kevin,
Thank you for your kind regards and support.
Please be aware that we take your comments quite seriously and we appreciate you concerns. We have been in the process of updating our aging website and materials in preparation for an amazing Water Dragon year and I believe you will find, once launched, that all of your concerns have been addressed. Yin-care® or “Jie Er Yin Xi Ye®” (洁尔阴洗液®) is such an important and widely used herbal preparation within the TCM community as a whole, it would be a pity to find it unavailable to our colleagues and patients who deem it so valuable.
I invite you to attend one of my lectures on the remarkable creation and history of this illustrious TCM preparation, from Yin-care’s roots in Sichuan, China by monks at “Qing Cheng Shan”, to how it has permeated mainland Chinese society over it’s past 25 years.
You are a true champion for the TCM community.
Wishing you and your family peace and prosperity,
Daniel James Hudson Lic. Ac, Doctoral Fellow
President
YAO Company, Yin-care
1305 South Washington Street
Denver, Colorado 80210
O: 303-777-7825
F: 303-777-7835
My response to Daniel:
Dear Daniel,
Thank you for taking the time to respond. If you will answer a few questions more specifically, I’ll be glad to update, retract, and apologize for the strong cautionary warnings I’ve written about Yin Care if I find your answers to be honest and correct. I know we are both busy with other projects, but this issue certainly is important to your company and our profession.
Yin Care is clearly a topical drug product. Even if it is made of herbs which are also suitable for dietary use, the method of administration clearly makes it not a dietary supplement. The FDA clarifies, here: http://www.fdaimports.com/industries/dietary_supplements/
—from above link:
Similarly, because dietary supplements must be ingested, they are never topical products (rubbed onto the skin or absorbed by the mucus membranes) So the category of dietary supplements does not include oral sprays or nasal sprays or topical creams or ointments applied to the skin, even if every ingredient in such a product is “natural” or “organic” or “herbal.”
—end paste
Please note I am very familiar with this because I have made and marketed various topical herb products in the past, and part of why I discontinued some of them was because I was previously ignorant of these laws, even though I had happy customers and was making profits from them.
Eva told me on the phone that Yin Care is a soap. I suspect she meant that is was imported and cleared customs as a soap. Can explain to me its legal status as a soap? If Eva was mistaken as to what category your company considers Yin Care to be in, please clarify. If you have any paperwork you can share with me that could convince me that Yin Care is legally imported, please share.
The FDA makes the line between soap, costmetic, and drug clear, here: http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm
—from above link:
How FDA defines “soap”
Not every product marketed as soap meets FDA’s definition of the term. FDA interprets the term “soap” to apply only when –
The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
The product is labeled, sold, and represented solely as soap [21 CFR 701.20].
If a cleanser does not meet all of these criteria…
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:
If a product –
consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
it is regulated as a cosmetic.
If a product –
consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
it is regulated as a drug.
If a product –
is intended solely for cleansing the human body and
has the characteristics consumers generally associate with soap,
does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic.
—endpaste
Because your marketing materials clearly recommend the use of Yin Care to treat serious diseases such as gonorrhea and other sexually transmitted diseases, your company is introducing it into interstate commerce as an unapproved new drug. Regardless of whether it is truly effective or not (even the Chinese research published on your site suggests it is less than 50% effective for gonorrhea, yet your more prominent marketing claims highly recommend it for that serious STD), this makes it an illegal drug product.
Do you plan to go through the FDA’s drug approval process so Yin Care can be a legal product and reach a wider market in a more appropriate manner?
I am very familiar with my scope of practice in Oregon and FDA laws regarding herbs in interstate commerce. The only legal way for an acupuncturist to use a formula like Yin Care is to buy the whole herbs from an importer that doesn’t make claims for them, then to boil them into a tea for topical use for their patients (or instruct their patients to do this at home), preferrably based on formulas in approved traditional texts. This is how TCM can be legally protected from FDA action. I do want Chinese herbs and formulas to be available to practitioners and patients in the United States, and I strongly feel that your marketing approach with Yin Care endangers that for us all.
Were you aware of these laws, or did I just open your eyes? Can you open my eyes and provide me with convincing evidence that I am incorrect?
Please note that in my discussions with other acpuncturists about this issue, I have found that even senior, published acupuncturist/herbalists are ignorant of the capability of gonorrhea to be asymptomatic and cause severe internal damage (while being transmitted to others) even when there are no more symptoms of burning and discharge. Part of why I’m taking your marketing claims for Yin Care so seriously is the likelihood that you are convincing acupuncturists to sell their patients your product with the claim that it will cure their STDs, which can easily lead to severe health damage and legal liability for the acupuncturist. If you were just marketing it to treat dandruff, I wouldn’t care. I suspect that you can see how claiming to treat gonorrhea is more serious than claiming to treat dandruff.
I feel that because Yin Care has already been promoted for treating gonorrhea, etc., for a while, even if you update your site to remove those claims now, that idea is still out there. The most ethical action you could take would be to withdraw Yin Care from the market while seeking approval to market it as the topical drug that it is. If you are not marketing it but feel the formula offers great benefits to our community, you can share any other details of the formula so acupuncturists can continue to use those traditional herbs as a topical tea if they want to.
If you do continue marketing it, but without claims, are you willing to send out some sort of letter to the TCM community warning them about treating STDs seriously and appropriately, i.e. not with something that may just make the symptoms go away? Please note that even without claims, it is still not a dietary supplement. Topicals such as Tiger Balm carry appropriate labelling that says ‘Topical Drug Product’ and ‘Active Ingredients: Camphor and Menthol’ with ‘Uses: For the temporary relief of minor muscle aches and sprains,’ etc. Camphor and Menthol are approved topical drug products for those claims. Will Yin Care have appropriate labelling soon? What will it say?
Because of the above facts, I have characterized your company as an “illegal drug smuggling operation.” I feel that your company is harming patients, acupuncturists, and the TCM community as a result. I would very much like to be proven wrong through factual evidence, and again will be glad to offer you an apology and a correction/retraction of the things I have written as a warning to other acupuncturists and their patients.
Sincerely,
Kevin O’Neil, L.Ac.
PS Please note that I am regarding this as a public discussion.
I think part of the problem is not understanding the laws about making claims about products, particularly about products you manufacture. For example, Lotus Herbs, in the early 2000′s, distributed a product manual that probably stretched the boundaries of medical claims. However, they changed their name to Evergreen Herbs and the manual was published by a separate company, Lotus Institute of Integrative Medicine which makes the claims legal. They still distribute this manual. Mayway also published A Practitioner’s Formula Guide (2008) on their products which was probably not legal. I suspect that they were advised of the problem and stopped producing the book – which is too bad. It’s a really good book.
I think the problem may have started with Kan Herb Company which produced the Jade Pharmacy Guide in the 1980′s. (I believe Jade Pharmacy is now called Kan Herbals). The Jade Pharmacy Guide was written by Ted Kaptchuk and made many medical claims though Dr. Kaptchuk stated them in an oblique way. In my opinion I think that the seller’s are guilty of ignorance and most are quite willing to change their literature when they realize it is not compliant with legal regulations. Hopefully, the maker’s of Yincare will bring their product literature into compliance now that you’ve pointed out their errors.
Michael,
Thanks for the thoughtful comment. I’ve addressed some of my research-based discoveries in a couple other posts: http://ancientway.com/blog/?p=1701 is a good one. The companies certainly know better, but are trying to ride the line. Distributing any written material that references/promotes your brand by name with medical claims is clearly over the line, even if it’s published by a different company. Yin Care has toned down their marketing materials, but as it is a topical drug, it will always be illegal until it is an approved drug product (in which case it needs to have a legal label declaring the active ingredients). Check out other women’s douching and anti-fungal topicals for their labeling. BTW, did you read about “Dr.” Kaptchuk’s degree? http://www.sciencebasedmedicine.org/index.php/dummy-medicine-dummy-doctors-and-a-dummy-degree-part-2-3-harvard-medical-school-and-the-curious-case-of-ted-kaptchuk-omd/ It’s a bummer to find that so much in the TCM world is based on deception and fraud. I hope that my writings can help to direct it towards a legal, ethical, safe & effective medical field.
Kevin
But a smiling visitor here to share the love (:, btw great pattern. “The price one pays for pursuing a profession, or calling, is an intimate knowledge of its ugly side.” by James Arthur Baldwin.
I appreciate reading critiques. Thank you.
I don’t see them claiming this product as a treatment or cure. I see them using it with those conditions. Just as you may use calamine lotion or selsun blue or topical steroids, boric acid, polysporin… or any of the other chinese or herbal medications.
You seem very passionate not only about the legalities but also about inquiring into the efficacy of this product. Maybe a good candidate for researching its efficacy? I would love to know if it works and its success rate.
Let me know if you hear anything.
Thanks
Michelle
Michelle,
Thanks for your comment. Yin Care changed their website dramatically after my post, though they never provided me with any documentation that it is legally imported. If you google for Yin Care STD you’ll still find several sites promoting it with the old marketing language.
If I’m presented with evidence that it is approved as a topical drug product (and thus legal for sale in the USA), good quality research that it works (i.e. research published in a reputable medical journal which documents methodology, etc.), or any other relevant data, I’ll update my post.
I also will approve any comments, even if they are critical of me. If anyone points out incorrect statements in any of my posts, I’ll update them and apologize. Since this post is now a page 1 google hit for “yin care” and “yin care effective herb wash” (#2!), it doesn’t seem useful to ignore it and hope that nobody notices it.
Since there are relatively safe, quite effective treatments for gonorrhea, chlamydia, etc., I have little interest in creating herbal treatments for those conditions. This is particularly the case since acupuncturists generally do not have the scope of practice to order lab tests to detect the presence or absence of those pathogens. However, since Arbor has been promoting Yin Care for profit for years, they should put their money into getting it legally approved to do what they said it would do. In fact, that is required *before* putting a drug on the market.
I’ve been learning more about medical ethics and research studies such as the Declaration of Helsinki (http://www.wma.net/en/30publications/10policies/b3/). Many of these principles boil down to giving study subjects proper informed consent before trying out a new therapy on them, not depriving them of effective treatment (such as the Tuskegee syphilis experiment), and only doing properly recorded scientific research which has been registered as an official clinical trial, has a written protocol, and will lead to new useful medical insights through responsible data collection and publication. These are reasonable principles. Most of us would find it horrifying if a drug company went to Africa and tried out a new gonorrhea treatment on poor people when it would have been cheaper to just use the existing treatments which are known to be effective. Frankly, it is seeming worse to me that Arbor would smuggle in a dubious treatment for STDs and promote it to acupuncturists (which, I hate to say, have a large subset of gullible people with poor scientific literacy) as safe and effective. Those acupuncturists then promote it to their patients, who will often believe anything they are told with confidence (especially if it means they don’t have to go to a Doctor). Instead of producing useful data to evaluate its efficacy, this is only done to make money. According to one site, they sell “millions of bottles” per year. I suspect they make at least $5 per bottle profit. Even if they only sell 100,000 per year, that’s enough to fund a decent study (and if they actually collected data on those 100,000, they would have their evidence). Anyhow, I think you get the idea.
I will certainly update if anything new is presented. I encourage anyone with good or bad info about Yin Care to post a comment.
Regards,
Kevin
Kevin,
I don’t know anything about this product. I do know there are some manufactures out there doing things they shouldn’t do.. in China. However, perhaps this is a good treament and of course they can’t exactly say that due to U.S. regulations. I can appreciate your concerns, but perhaps you should test it out and get a few results to see if it is truly effective.
Chris,
Thanks for sharing your thoughts. It is the duty of the person making the claim or marketing the product to show that it is safe and effective for its intended use. I would never think of marketing something to treat a communicable disease such as gonorrhea without going through the proper channels. It’s one thing to market an herbal supplement for something such as boosting energy or relieving stress but quite another to cure an STD. Apparently no one else has pointed out the situation around Yin Care, so I feel my posts about it are an important counterbalance to the years of illegal marketing the importers invested in. I remain willing to update, alter, or retract my post if I’m shown that Yin Care is legal and effective.
Kevin
Kevin, given your strange and deep concern with this topic, I think you either need more clients or therapy. Consider a career change.
Dear Roja,
Thanks for your input. Are you saying the alternative medicine world isn’t a place for someone who thinks medicines for sexually transmitted diseases should be safe, effective, and legally imported? Perhaps you’re right then. I should probably leave the herb world to people who don’t even question the legal and ethical implications of recommending something like Yin Care to their patients. I mean, what could possibly go wrong with telling someone you have an effective treatment for gonorrhea when you don’t even have access to lab tests to see if they have it or it’s been cured?
What kind of therapy would make me care less about this stuff? Numbing my brain in a bar, perhaps…
I’m open to a real argument that the points I made are incorrect. However, Roja, you’re another prime example of the way alternative medicine ‘true believers’ use condescending personal attacks without actually addressing issues using logic.
Congrats, you fit right in to the TCM world!
Yin Care is a wonderful product, I find it odd that you reference the FDA so much…As if their in the business of protecting consumers and not “BIG PHARMA” as a woman I can say that their products work!
Annie,
Many people are concerned about quality control of Chinese-made products, even when legally imported. Especially after the melamine-tainted dog food killed so many pets, I think many consumers have been more cautious with all Chinese products. If you feel comfortable using an admittedly smuggled-in Chinese product to treat vaguely diagnosed conditions in your reproductive tract, I suppose that is your choice. At least having read my blog about it, you’re a bit more informed. At what point do you ask yourself “Do I really know what’s in this?” If the company will tell Customs it’s a soap and ignore the rules regarding labeling and FDA approval for topical drug products, why would you think that they would actually be honest about their ingredients and manufacturing practices? Can you see why this may not be a good idea for treating “STD’s” as a general category as the marketing materials recommended for so long (until after this post was published)? Or in your mind, if something is anti-FDA, does that automatically make it safe and effective?
Feel free to share more about why you think Yin Care is a wonderful product, and let us know at what point you’d be cautious about its claims and use.
Thanks for this page.
You’re welcome, thanks for taking the time to let me know you found it useful.
I found the information on this page very useful. I was trying to find a complete ingredients listing and preservatives used and I stumbled upon this post. I will definitely not be purchasing this product, knowing more about it and the company’s practices. I don’t know why in some of the comments the posters feel threatened by your logical approach to the proper labeling, distribution and claims made by those who sell herbal concoctions. Like you said, if they really love the product so much why not buy the individual ingredients and create your own treatment to test the effectiveness against the commercial product. I suppose these posters are just lazy and can’t stand the thought of actually putting in a little more work to ensure that what they are putting into their bodies is actually safe and that they are not being lied to.
Biased info. The FDA can no be trusted. Acupuncturist are licensed to order blood test and trained to give a diagnosis and a Phyical examination. Well written article however there are many ways to go about caring for the body with STD. holistic care does a very good job of it.
Ana, I don’t know of any TCM schools or states which prepare acupuncturist to order and interpret blood tests for STDs or anything else. Definitely it’s not the case in Oregon or California. In California, acupuncturists specifically are prohibited from claiming to treat any diseases (essentially limiting them to pain relief). Additionally, I suspect you can’t find any decent research supporting your claim that “holistic care does a very good job” of treating STDs. If you do, you’re welcome to post some links here.
Even if the FDA isn’t a perfect entity, I don’t see that as a reason to use unproven treatments for communicable diseases which can be cured with conventional medicine.
Your logic is faulty. Before you go drawing conclusions and falling down your slippery slopes, you may try to study up on how to make logical arguments rather than writing arguments that are merely based on the over use of logical fallacies to make your point. Whether you are right or wrong, your arguments were so poor logically that I couldn’t possibly consider them sound enough to base any decisions upon.
Dear KP,
I’m open to you being more specific than that. You didn’t make any acutal points or arguments against my reasoning, you simply dismissed them and said they weren’t logical.