The best way to get a sense of where the FDA stands on issues of compliance is to see what they have done in the past, who has been cited, for which violations, and the actions required to mitigate these violations.
Firstly, there are two sources that I've found that describe case studies in DSHEA actions.
1) The FDA has a page entitled the Dietary Supplement Enforcement Report . This page articulates some of the red flags that the FDA looks for first when deciding where to focus its compliance enforcement. You can review this page by clicking on its title above. These red flags were also described on the previous page in this DSHEA feature.
2) There is also another source for information on the FDA's patterns of enforcement actions linked from their information page on purchasing drugs and dietary supplements online. There, you can click on FDA enforcement warning letters sent out to online sellers. Once into the yearly lists, you can search and sort based on criteria that you choose.
It should also be noted that of the 112 listed cyber letters for the years of 2005 and 2006, roughly 10% of actions target Chinese herbs in particular. I don't know for sure, but I can say that Chinese herbs do not appear to have been singled out by the FDA.
By the time you read this, the following violations may have been corrected. In some cases, I am surprised at how small a change to the overall website has been requested to bring the labeling into compliance. Instructions on how to locate the current status on any of these actions can be found on the FDA's Freedom of Information page.
Cyber letters issued from CFSAN are to Internet Website Operators promoting dietary supplement products that claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.
Violations include the following text fragments located at online retailers. Out of respect to the companies that have been targeted by the FDA (justly or otherwise) their names have been removed from this text, though a simple link to the "source" website will be provided.
One website promotes their formula as being effective for cancer which is already a red-flag keyword. Cancer is a disease. Dietary supplements cannot treat disease. [Source]
The XXXX products are herbal dietary supplements. The active herbal ingredients aims to control, inhibit and destroy cancer cells. It's function is complementary to that of western therapies.
One website promotes a famous pre-made herbal formula for "wind cold" with a somewhat gentle statement describing its traditional uses. This too was targeted as out of compliance. This is particularly chilling as this formula addresses something that I had hoped would be considered a minor transitory pathology as to belong to one of those exempted non-disease states. Apparently it is not. [Source]
Gan Mao Ling "Classic Chinese herbal formula for flu & cold symptoms"
Here's another site that describes traditional uses of Chinese herb "Gou Qi Zi" currently marketed as Goji berries or Goji juice. Notice the numerous disease claims such as palpitations and anxiety. The "insomnia" claim could have possibly achieved compliance with the "transitory" qualifier. Also, there is the "anti-inflammatory" statement as well as implied disease claims with all of the listed testimonial conditions. [Source]
"In Oriental medicine, they are said to correct chi deficiency meaning conditions such as ... insomnia, heart palpitations, and even anxiety."
"Mature Goji fruits contain ... beta-sisterol [sic] (a very powerful anti-inflammatory agent) ...."
"Order Now and get absolutely FREE - A Printable E-Book "Himalayan Goji Juice" Your Essential Guide" with ... every case or more Goji juice orders. ... This guide includes: ...
TESTIMONIALS
- Arthritis
- High Blood Pressure
- Diabetes
- Fibromyalgia
- Migraines
Here's a site that tries to get by with using some of the allowed actions such as "regulate" and "promotes". Of course these terms are meaningless when teamed up into claims such as "Promotes Cancer Prevention" which is to say that it prevents cancer. [Source]
Lycium Barbarum Goji Juice
"Helps Regulate Hypertension"
"Anti periodontal Disease"
"Goji juice can also help reduce cholesterol."
"Anti Allergenic"
"Goji juice has traditionally been used to help relieve insomnia ...."
"Promotes Cancer Prevention"
"Dynamic Health Laboratories TM unique vegetarian Goji Juice Blend contains the added benefits of Black Cherry Juice Concentrate, Apple Juice concentrate and Pear Juice concentrate. ...These compounds are essential to ... combating many types of cancers."
"[T]he same Polysaccharides found in Goji berries ... may also help to reduce and relieve hypertension ... and periodontal disease."
Here's an example of implying a disease claim based on studies that promote the idea that Yun Zhi is effective on cancer. [Source]
Coriolus Mushroom Extract Powder (Yun Zhi)
"Many experimental studies and clinical investigations of PSK and PSP [Yun Zhi's
purported active ingredients] in relation to their anti-tumor effect and especially for their potential use in cancer immunotherapy have been reported."
"These studies include the clinical trial on 485 cases of cancer patients who have used Yun Zhi extract for the treatment of cancer alone or in combination with chemotherapy and radiotherapy. The results of these studies have consistently shown increased survival rates and improved quality of life without toxic side-effects. The total effective rate is 82.96%."
"Animal studies investigating the efficacy of Coriolus versicolor has indicate it has ... a broad antineoplastic scope. It prolongs the survival time of irradiated (cancer-induced) mice by stimulating phagocytic activity of macrophages and improving the functions of the reticuloendothelial system."
"It also has antiviral and antibacterial effects, which includes anti-hepatitis B and migratory hepatitis virus."
"Modern clinical research has focused on using the water extracts of this mushroom to stimulate and strengthen the immune health of people with cancer."
This next FDA letter describes in detail their reasoning behind this non-compliant "dieter's tea" that includes Ma Huang (Rx. Ephedra) which has been banned by the FDA. Ma Huang is not an approved ingredient that is "Generally Recognized as Safe" (GRAS). "GRAS" is a term most often applied to food products and this particular item is being assessed as a food product as opposed to a dietary supplement. I presume that this is because tea bags are considered a food item rather than dietary supplement. This brings up a good question too, what's a dietary supplement (as opposed to a food item)? I don't have an answer for you yet, but the issue of how the ban on Ma Huang affects dietary supplement manufacturers but not practitioners of TCM is still unknown, even people from the FDA with whom I've spoken are unclear as to the difference. I haven't yet asked an FDA compliance officer though.
In general usage, "adulterant" suggests something that accidently got into the formula. However the FDA uses the term to describe anything in the formula that hasn't been approved for its inclusion in the formula.
It is a three page letter and rather than describe its entirety here, please use the provided link to download the letter and read it for yourself. FDA Warning Letter - Ephedra
XXXX (brand name) is one of the newer forms of Chinese medicine where a proprietary blend of ingredients have given rise to a new brand name that other TCM professionals may not be able to readily recognize. It is marketed as highly researched in Thailand, but I was unable to generate any peer reviewed citations. Needless to say, the FDA wasn't too crazy about their making disease claims for HIV. Had the marketers of XXXX (brand name) simply stated that their formula will "activate the immune system" the would have probably been okay. [Source]
"XXXX: a new mix of 12 of the most powerful traditional Chinese herbs to activate the immune system to fight HIV"
"XXXX is developed in Southern China where HIV/AIDS has become a serious epidemic, starting years ago through migrant workers to Thailand. There, in Northern Thailand, the medicine has been tested first and is since then becoming very popular not only because it is the least expensive of all available drugs but also because it is restoring the immune system function of the body so efficiently that in the majority of patients the CD4 counts are getting back to normal within 1 to 3 months, and a large number of viral secondary infections are cured at the same time. While this is a new way of looking at the treatment of HIV, the medicine itself is but a sophisticated mixture of traditional Chinese herbs to cure immune system deficiencies."
This site promotes American ginseng as a preventive for cancer, among other diseases. [Source]
Wild American Ginseng Capsules
"A series [sic] laboratory experiments ... showed that American wild ginseng: ... Inhibited human breast and prostate cancer cells; the higher the concentration of ginseng, the more it slowed down the rate of cell proliferation. "It doesn't kill the cells, but you can raise the dose to completely inhibit proliferation. It arrests the cell in a certain state of development." They also discovered that the tumors in the treated mice with a water extract of American ginseng were 50 percent smaller than those in the untreated mice."
"Researchers ... have found that taking American ginseng before a meal reduces blood sugar in people both with and without diabetes. The study appears in the April 9 issue of the Archives of Internal Medicine, a publication of the Journal of the American Medical Association (JAMA)."
"A study comparing groups of people over time suggests that regular intake of ginseng may reduce one's chances of getting various types of cancer, especially lung, liver, stomach, pancreatic and ovarian."
"INDICATIONS ... diabetes ... cancer ... inhibits the growth of cancer cells ... and reduces the side effects of chemotherapy and radiation ... hepatitis B & C ... cirrhosis ... high cholesterolor [sic] ... reduces high cholesterol ... inhibits the aggregation of platelets... alcoholic ... lowers blood alcohol levels ... cardiovascular disease ... normalizes blood pressure; prevents from arteriosclerosis... "
"Mr. Liu of Brooklyn, New York suffered from nasopharyngeal carcinoma ten years ago. He has never fully recovered following chemotherapy. Last year, thyroid adenoma developed on both sides of his throat. He started taking WildSenergy upon recommendation by his friends. After a month of recommended usage, the tumours [sic] became smaller. They almost disappeared three months later. ... His tumour [sic] specialist was pleasantly surprised with these improvements. He has now begun his second chemotherapy to clear up the remaining cancer cells. He has not experienced any undesirable side effects of chemotherapy this time."
"Seventy-two-year old Mr. XXXX of Flushing, New York was diagnosed as having middle stage liver cancer later stage cirrhosis. After taking Liverklin for three months, his liver function improved incredibly with AFP index dropping to 265 from 1360! There were also significant improvements on other indexes such as AFP, ALT and AST, etc."
This next product uses the word "normalize" which implies that the blood pressure is abnormal. Abnormal = disease. There are also some suggestions that research supports the disease-treating effects of this herb. [Source]
"Siberian Ginseng .... The plant and extracts are used to normalize high or low blood pressure ...."
"Reputed effects include ... control of certain forms of diabetes, reduction of tumors and control of artherosclerosis [sic]."
Again, with this product, more disease claims are made, in this context describing depression and anxiety as well as claim to mitigate chemotherapy side-effects. [Source]
(Brand Name) Eleuthero Extract
"Eleuthero... has been used during chemotherapy to limit side-effects."
(Brand Name) Rhodiola Rosea
"Rhodiola Rosea has been used...extensively for the treatment of depression and anxiety ...."
"Modern alternative medicine practitioners prescribe Rhodiola Rosea for: Depression..."
This Huang Qi supplement was promoted as an anti-inflammatory which is something that only drugs can do. [Source]
(Brand Name) Astragalus 400mg 100 capsules "Astragalus has also been found to reduce inflammation ...."
This next company did something that many of us thought we could get away with. Simply stating as a fact that "traditional uses" of a given herb would be just reporting historic uses. However when there is an economic interest as manifested by a link to a purchase opportunity or a favored website that does sell the product, then the statements are no longer educational in nature, but they become "claims".
Never heard of Gymnema as a traditional herb, anyway. As I understand it, this is a somewhat new addition to the TCM pharmacopeia. [Source]
Ginger
"Traditional uses of Ginger include ... alleviating the symptoms of the common cold, ...mild asthma symptoms...."
"Pharmacological Properties ... may prove useful in the prevention of migraine headaches it could be useful in childhood and juvenile migraine headache... possesses anti-ulcerative properties"
Gymnema
"Gymnema silvestre ... has traditionally been used in the treatment of arthritis, gout, and most notably diabetes."
"Pharmacological Properties hypoglycemic activity shows promise in the treatment of Type 2 diabetes reduces blood glucose levels ... reduces and normalizes plasma lipids (cholesterol, triglycerides, and free fatty acids) may prevent reduction of lean body mass associated with diabetes ... normalizes blood sugar levels ..."
Next: wrapping it all up.
