I’m in process of becoming an Amazon Seller, so I can grow my business by offering select products on Amazon.com. I’ve been a happy Amazon Prime customer for years, but was put off last time I looked at selling there due to the higher fees than eBay (15% for starters). However, since I really want to grow my business and offer some of my unique products on Amazon, I’m biting the proverbial bullet and going for it.
I love Amazon Prime, especially now that it offers free Downton Abbey episodes!
If you’ve been reading my blog posts, you know I have strong opinions about what is legal and what is ethical. I want to be known as a trustworthy source for safe, legal supplements and information. Part of reaching this goal includes educating my customers about what is unsafe and illegal. I’m taking the time to read Amazon’s rules as I want to do it right and be honest with them and my customers.
Amazon has a Seller info page for Drugs, Drug Paraphernalia, and Dietary Supplements.
Examples of Permitted Listings
Reminder: all listings and products must comply with all laws and regulations.
- Drugs approved for over-the-counter purchase that are not otherwise prohibited by Amazon policies and are appropriately described and labeled
- Dietary supplements that are not otherwise prohibited by Amazon policies and are appropriately described and labeled
Examples of Prohibited Listings is the fun part, and includes, obviously, illegal drugs like hashish and heroin (LOL, “Heroin Withdrawal: when overnight shipping isn’t fast enough!”). It also includes products which “simulate the effects of illegal drugs” such as synthetic cannabinoids, kratom, and the crazy new “bath salts.” Products intended to help people beat urine tests are prohibited. All Ephedra/Ephedrine products are banned (sigh, we miss you, Ma Huang), as are Ergotamine products (it’s a precursor to LSD).
Oh, Ma Huang, you would have been fine if only used as twigs in tea, not concentrated extracts in weight-loss and sports supplements!
Then we get to “Products that the Food and Drug Administration (FDA) has determined present an unreasonable risk of injury or illness.” It would be nice if there were a link to an updated list on FDA.gov, but I can see that it’s a reasonable category to account for new things like “bath salts” that may come on the market and get identified as dangerous (though as a fan of colloidal silver, I’m relieved to see that is allowed on Amazon–for now. It’s banned on eBay, though you can buy some ‘herbal smoke’ on there still). Following that is “Products that are adulterated or misbranded.” Misbranded drugs and adulterated drugs are specific legal terms which I’ll go into detail about below. Prescription drugs are next (they require medical supervision). Then “listings claiming that a product is intended to be used for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans and/or animals unless the claim is approved by the FDA” is stated with 3 categories as examples:
1. Chelation products (these are often marketed to remove heavy metals or cure hardening of the arteries, but can sometimes cause harm by taking out needed minerals).
2. Unapproved remedies for cancer: This includes all of the “Native American Black Salve” category of Bloodroot and escharotic products which can do things like make your nose fall off your face (Warning! Graphic image) while they don’t really “only target the cancer cells.”
3. Unapproved remedies for sexually transmitted diseases: Yes, Yin Care “Effective” Herbal Wash, I’m thinking of you. This is complicated, as Yin Care is still available on Amazon, but less than before I wrote in detail about it being a smuggled in, fraudulent, unapproved drug product that can cause serious harm to acupuncturists and their patients who rely on Arbor International’s marketing/labeling materials which for several years have promoted it to treat “S.T.D.’s” as a general category. Oh wait, they don’t make those claims on their site anymore since I wrote about it! Still, they have not responded to my direct request that they provide me any evidence that their product is legally imported. The labeling still gives it away that it is an illegal, unapproved, misbranded (oh, there’s that word!) topical drug product, so I’ll keep writing about it in the interest of consumer (and practitioner!) protection. Also, several other sites still are promoting it using the copied marketing claims that Yin Care was promoted with for several years. Fortunately, my blog post is now the top Google hit for “Yin Care STD,” “Yin Care gonorrhea,” and the 4th hit for “Yin Care uses.”
I’ve been stunned at how many people have found my blog searching for “effective herbs for gonorrhea” and “natural cures for gonorrhea.” Please, people, go to an MD! The cure is a single dose of a proven effective drug, but you also need to be tested before and after to make sure that the diagnosis is correct and the treatment effective. If you have a drug-resistant strain of something, ask your doctor if you can combine a good colloidal silver with the prescription treatments (see, I am still a fan of natural medicine!). Just please don’t try to treat STDs at home on your own. Acupuncturists, you should know better–your scope of practice doesn’t cover lab tests for STDs, and if the symptoms of burning, discharge, sores, and itching go away, that doesn’t mean the STD is cured. Send me hate mail if you want, but that is the truth. People and babies can die if these things aren’t treated correctly, so don’t mess around with “natural cures for STD’s.”
I’d apologize for my rant, but apparently it’s one of the most useful things I do.
Next on the list of Amazon’s prohibited supplements are things tainted with drugs. Some Olympic athletes who have had their careers ruined because they were taking an “all-natural” supplement that happened to have steroids in it. Yes, some of them should have known better, but some of them were assured they were just taking vitamins or safe herbs.
Following are expired products, opened products, product labeled ‘sample’ or ‘tester,’ products which have been recalled, and products which have been the subject of criminal enforcement, seizures, or warning letters (the weird Chinese formula Six Spirit Pills/Liu Shen Wan is on that list, according to Amazon. It is apparently available many places online still, which fail to note that it has Arsenic and the Psychedelic Toad Venom Bufotenine in it. Looks like that deserves its own blog post, as the acupuncturist who sold it to the poor lady in the link above was arrested after her skin blistered and started peeling off).
An important group which many people don’t understand are topical drug products, or as Amazon puts it: ”Products that are marketed as dietary supplements but that are not ingested (patches, injectables, suppositories, etc.)” This is another reason that Yin Care is illegal–it’s not a dietary supplement and doesn’t have the correct labeling to be a topical drug product (i.e. with an approved active ingredient, proper instructions for use, etc.). Check out Tiger Balm–it has correct labeling (i.e. Active Ingredients: Camphor and Menthol, Uses: For temporary relief of minor muscle aches, etc.). Can we agree that treating gonorrhea is more serious than treating muscle aches from over-exertion?
Amazon finishes the list by insisting that products need to have English on their labels, not just foreign languages.
Those policies make sense to me, how about you? Do you think Amazon is being too harsh on “natural medicines”? I don’t. I would like a safe, level playing field where by offering the best service and best cartoons (I put a cartoon postcard in each order currently) along with the best blog, I can grow my business responsibly. As it is, I’m competing with hundreds of sites and companies who illegally market some pretty scary stuff. In fact, as with Yin Care on Amazon, it is obvious that Amazon doesn’t currently have a team that can keep up with all of the products on its site to make sure they all follow the rules. I am signing up largely to offer the best-selling Plum Flower brand items, like the economy size bottles. There are sellers providing those on Amazon right now, so I assume Amazon approves. Plum Flower teapills are, in my opinion, the best, most legal/ethical Traditional Chinese Medicine product line on the market, which is why I happily prescribe them in my clinic and sell them on my site. The final factor which made me want to jump into the Amazon fray is that when you search for “Plum Flower brand” the top hit is someone who is using my product image without permission (I use that specific fabric background as a stylistic identifier for my site):
Watch out, Amazon Sellers, here I come!
So what specifically do “misbranded” and “adulterated” mean in regards to supplements and drugs? Here are the FDA’s definitions, as reported by Wikipedia:
The primary basis under which food may be deemed misbranded under the Act is if “its labeling is false or misleading in any particular”. Labeling is defined elsewhere in the Act, and includes:
…all labels and other written, printed, or graphic matter
- upon any article or any of its containers or wrappers, or
- accompanying such article
Under the second part of this definition, it has been held that a food substance sold in conjunction with a book or pamphlet which makes false claims about the benefits of that substance is misbranded. If books making false claims about a food are sold in conjunction with that food, the books themselves may also be seized and destroyed – even if the author had no intention of selling the book in conjunction with the food. However, if a store happens to be selling both a food and a book which makes false claims about that food, and is selling the items separately, then no misbranding occurs. This is so even if the book and the food are both produced by the same company, and even if the maker of the food encourages the seller to carry the book.
In terms of determining whether food is misbranded, the FDA only monitors labeling, and not advertising, which instead falls under the authority of the Federal Trade Commission. However, the FDA will review the advertising of a product to determine whether it is to be regulated as a food or as a drug, based on the claims that the manufacturer or seller makes about its properties.
The FDA’s site has more details about misbranded foods here. An important clause is this:
(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if—
(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and
(C) the statement contains, prominently displayed and in boldface type, the following: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”.
A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.
Misbranding a food turns it into a drug. This is a key concept to understand as we explore what is legal and what is not. The Dietary Supplement Health Education Act was a big gift to the herb and supplement industry. There is no need for Chinese herbs to be illegal or misbranded. The restriction is not on the herbs, but on claims made about them as they are introduced into interstate commerce. Licensed acupuncturists in states where the scope of practice covers prescribing herbs as medicines can take legally imported/distributed herbs and prescribe them as drugs in their states, legally. It is companies who include marketing materials making drug claims that make herbs illegal and subject to FDA enforcement actions. This is why such companies are endangering legal access to traditional herbs for everyone. It is sadly ironic that these are the same companies who want their products to only be available directly through practitioners, not on the internet directly to the end-user. I will continue to write more about this, as it is an important and complicated issue.
Here is the definition of a drug in the Food, Drug, and Cosmetics Act:
(g)(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
The important line is that a drug is an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”
Adulterated foods are things which have undeclared ingredients or insanitary ingredients. Wikipedia puts it:
The Act sets forth several circumstances under which food will be deemed adulterated. The primary definition set forth is that food is adulterated if:
- …it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.
Added substances are treated separately by the FDA, meaning that the sale of an article or substance as food will generally be permitted if that article or substance is not ordinarily injurious to health.
Food is also deemed adulterated “if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food”; if it was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”; if it was produced from “a diseased animal or of an animal which has died otherwise than by slaughter”; if it was packaged in a poisonous material; or if it was intentionally irradiated outside of irradiation guidelines set forth by the Act. These definitions are also independent, meaning that food that is “filthy” or has been “held under insanitary conditions” is still in violation of the Act and subject to condemnation even if the owner can demonstrate that it poses no actual threat to health. The phrase “otherwise unfit for food”, although seeming to be a catch-all, has rarely been invoked. It would apply to a circumstance such as a seller offering wood chips as food, which might be safe to consume and prepared under sanitary conditions, but would be impossible to chew.
The FDA’s site has some more details on adulteration of dietary supplements:
(f) Dietary supplement or ingredient: safety
(1) If it is a dietary supplement or contains a dietary ingredient that—
(A) presents a significant or unreasonable risk of illness or injury under—
(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5 to affirm or withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
This makes me wonder if Aconite containing supplements are going to be considered adulterated soon, as in Hong Kong they found that 61% of Significant Adverse Effects (i.e. hospitalizations due to side effects) are from Aconite. Another way to put this is that Aconite causes more problems than all other Chinese Herbs combined. This is in Hong Kong, where you can easily get anything–arsenic, cinnabar, toad venom, Ma Huang, etc.
So Aconite may cause a supplement to be adulterated if it is likely to cause harm, and a supplement product, whether it contains a toxic ingredient or not, is misbranded if it makes claims to treat diseases. I’m pretty focussed on serious diseases when I look at risky products, I’m not that concerned about minor conditions. Certainly no respectable US company would still be promoting Aconite-containing supplements for things like cancer, STDs, and kidney failure? Let’s see what Google pulls up today (March 6, 2012):
Well, look at that! Classical Pearls is still promoting Aconite in Tiger Pearls for kidney failure and colon cancer, and gives specific dosage recommendations for children and breast-feeding women:
Wow, I even gave them plenty of heads up about these issues, time to answer my questions directly (I’ve been ignored), and then blogged in detail about it, and they still have this info which comes up easily in a Google search! I guess I’ll keep writing about it to warn patients and practitioners to steer clear of their misbranded unapproved drug products!
Before I read their product claims and researched Aconite in depth, I had briefly listed their product line on my site (without claims, as is my normal practice) based on customer requests. I got a call within a couple days from a Classical Pearls employee who requested I take them down, and I complied quickly. Because I want a fair, legal marketplace, I keep my eyes open for other sites that offer things I’ve been told that I can’t offer. I tipped Classical Pearls to another site offering their products with Heiner’s serious disease claims, about 2 weeks ago (I was thanked). Look what’s still up:
Ocean Pearls is my favorite of the misbranded Classical Pearls line, as it is marketed for both serious cancers and STDs. It has dosage recommendation for breast-feeding women and no warnings at all about the fact that Aconite can cause serious side effects (like heart arrythmias, coma, or death).
“Buyer Beware” is as important a concept as ever! As you can see from the laws I’ve referenced, the cases of harm which are well-documented, and the products on the market which are promoted through acupuncturists, it is not sufficient to think that because your acupuncturist recommends something it is safe and effective.
I’d be glad to offer my opinions and knowledge to any of my readers who are taking or considering taking a Chinese herb product, whether it is from Chinatown, an acupuncturist, or another site. It would be best for you to e-mail me images of the packaging, ingredients, and any other details. If you are getting herbs from an acupuncturist, it is totally within your right to request a photocopy of the references they are using to recommend it to you. You can send that to me. If something is interesting, toxic, or completely inappropriately marketed, I’ll probably blog about it to help warn others. I offer this as a free service. I can’t guarantee I’ll know everything or have the time to review each ingredient in detail, so you should do your own homework as well. In fact, if you discover something is harmful, whether through personal experience or your own research, please let me know about it. You may help others avoid wasting time, money, or their lives.
It is my goal to be a trustworthy source of good information and legal Chinese herb products. This is how I want to grow my business and reputation. Thanks for reading, and please help encourage me by signing up for a free e-mail subscription to my blog (at the top right of each blog page, no spamming ever!) or leaving comments (anonymous is fine). You’ll be the first to get my posts about toxic products, good products, and recalls, as well as my popular Acupun and Zen Bunny cartoons!