A 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.

Here’s one on multiple STDs

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.”

STDs & Infertility

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.

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.

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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).

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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.