The FDA, quality assurance and herbal / nutrient medicine
The United States is perhaps the last major industrial country to fail to adopt international standards concerning herbal quality and patient and public assurance. While there are many reasons for this shortcoming, perhaps the most important is money, and the growing industry of herbal and nutrient medicines, which now exceeds 19 billion dollars per year and is becoming dominated by the pharmaceutical industry. Now, unpatented herbal products and effective nutrient medicines are potentially causes of big losses in the pharmaceutical industry, which makes enormous profits from patented chemical medicines. Obviously, the pharmaceutical industry will do whatever it can to protect the profits from patented medicines and discourage a rising resurgence in the trust and belief in herbal and nutrient medicines that cannot be patented. The public is gaining a growing awareness of these issues and becoming curious concerning the actual quality and effectiveness of advertised herbal and nutrient medicines. The amount of advertising does not translate into assurance of quality, and in fact, we are seeing the gross manipulation of the herbal and nutrient medicine industry with numerous government studies showing that a high percentage of heavily advertised non-professional herbal and nutrient medicines sold off the store shelf are not what they say they are in the United States.
In 2013, the New York Times noted that several large studies using DNA testing to definitively identify the contents of herbal and nutrient medicines sold over-the-counter or online found that nearly a third of all products randomly selected and tested with the DNA "barcode" method did not contain the herbal extracts or nutrient molecules listed on the label. In response to this alarming finding, experts in Canada performed a study of 44 randomly selected commercial herbal products and found that in 33 of the 44 medicines, that other chemicals were substituted for the herbal and nutrient extracts and molecules listed on the label. This report was published in the journal BMC Medicine in 2015. Concurrently, on February 2, 2015, the New York Times reported that the New York State Attorney General's office announced that they had completed a long investigation of these issues, finding that about 80 percent of randomly selected herbal medicines that were most highly promoted or produced by the 4 largest drugstore chains, Walmart, Walgreens, GNC and Target, did not actually contain DNA evidence of any of the herbal extracts listed on their labels, and most of these products contained nothing more than rice powder and vegetable filler, issuing a cease and desist order to these corporations to stop this selling of fake herbal medicines off their shelves. It is surmised that this was a purposeful strategy to undermine the public trust in herbal medicines, producing no benefits due to consumption of fake herbal products. The patient population should be aware that only professionally prescribed herbal medicines come with actual quality assurance in a country that steadfastly has refused to operate by minimal international standards of regulation of this industry.
The FDA, or U.S. Food and Drug Administration, regulates the realm of "dietary supplement products" under a different (and minimal) set of regulations than those covering prescription and over-the-counter drugs and "conventional" foods. The term dietary supplement product applies to both herbal and nutrient medicine. The only legislation mentioned by the FDA in regulating these medicines are the 1994 Dietary Supplement Health and Education Act (DSHEA), and the cynical "Final Rule" 21 CFR 111. These regulations, though, do not provide for actual assurance of quality and content. The 1994 act provides for assurance from the manufacturer that the product is safe before it is marketed. When a product is found to be unsafe, the FDA is responsible for taking action. Manufacturers do not need to register their products with the FDA or get approval before producing or selling these products, and an enormous number of companies and products now exist, much larger than the capability of the FDA for investigating reports of unsafe products. Large studies have determined that about 80 percent of products sold on the store shelf do not have the actual product or dosage of product listed on the label. There is no penalty for producing and marketing products that are not what they say they are.
After many years of concern about the unreliable quality and content of commercial herbal and nutrient medicine products, the FDA finally produced legislation calling for some mode of government regulation in the industry. The cynically entitled "Final Rule", though, merely provides for a requirement of a yearly report describing the manufacturers adherence to production standards. These production standards benefit large producers over small companies, and do not supply any guarantee that the actual herbal extracts and nutrient medicines are of correct types or that they are free of contaminants, or that they are even actually in the product or at the declared dosage or concentration. If a serious adverse event is reported concerning these products, the distributor of the product is required to submit a report. By law, the manufacturer is responsible for ensuring safety, and there is no regulation of quality or actual content. The FDA states on its website that the question of reliability is a difficult problem, and recommends that the consumer contact the manufacturer to get information on safety, effectiveness and reliability of the product.
This is not to say that the FDA does not interfere with herbal and nutrient medicine products. The FDA states that a product sold as a dietary supplement must not promote on its label that it is a treatment, prevention or cure of any specific disease or medical condition, according to the provisions of the 1994 act (DSHEA). The label refers both to the label itself, and accompanying material that is provided with the product. The manufacturer of the herbal and nutrient medicine may make three types of claims: 1. health claims; 2. functional claims; and 3. content claims. These claims may link an herbal or nutrient medicine to a disease or health-related condition. When a functional claim is made of these medicinal chemicals, a disclaimer is required stating that the functional claim has not been evaluated by the FDA, and that the product is not intended to diagnose, treat, cure or prevent any disease. Now, it is obvious that these researched herbal and nutrient medicines are intended to treat diseases, but the law requires that all producers, distributors, and prescribers of these medicines lie about this, which is confusing for the patients and purchasers. In addition, since the FDA refuses to actually evaluate the herbal and nutrient medicines, there is no possibility that this 1994 law could apply to a functional claim. This ploy was carefully thought out, and continues to confuse the public.
Claims of the actual effectiveness of herbal and nutrient medicines are made, and these claims are regulated not by the FDA, but by the FTC (Federal Trade Commission), which has its own laws and regulations concerning these trade practices, and methods and reasons for enforcement. In other words, trade issues, dominated by big business, guide the enforcement of the claims of effectiveness and function of herbal and nutrient medicines. This results in legal enforcement of FTC rules when any herbal or nutrient product is commercially sold, or advertised, but not when it is legally prescribed by professional herbalists, such as the Licensed Acupuncturists, and Naturopathic Doctors. The enforcement of FTC rules by the FDA is very lax, though, concerning these products, and companies have continued to sell many herbal and nutrient products for years that have outrageous unsubstantiated claims, yet, products advertised and sold that are formulated by professional herbalists with assured quality are routinely harassed by the FDA. These confusing rules and lack of rules result in allowing an unregulated commercial sale of questionable herbal and nutrient medicines in stores and on the internet, while legitimate herbal and nutrient medicines must be careful to not make any claim that they actually treat a true medical condition. Only professional products, with quality assurance within the professional herbal medical arena, can be fully trusted to meet the standards of quality, dosage, and ingredient content when seeking medical care, though. These products unfortunately often are forced to adopt names that are indirect and confusing to patients, and must be careful not to make functional claims, no matter what scientific evidence supports their purpose and efficacy. In 2014, we have a vast amount of scientific research and human clinical trials that demonstrate the specific effects and efficacy of these professional herbal and nutrient medicines, yet the laws still pretend that we are living in an era preceding this research.
One example of how this system works, or doesn't work, is the class action settlement of a heavily advertised and popular nutritional supplement drink with glucosamine and chondroitin, and calcium and boron, marketed by The Elations Company LLC and sold in many of the largest drugstore chains, such as Walmart, Walgreens, CVS, Target, Save Mart, Supervalu, 99 Cent Store, Big Lots, etc. as Elations Healthier Joints Daily Joint Supplement Drink. The lawsuit, finally settled out of court in August of 2015, provides $1.35 million for California purchasers of the supplement, and concerns falsely advertised claims that the high dosage of glucosamine and chondroitin was clinically proven to improve joint health and relieve symptoms. Despite the fact that these chemicals produced by the joint tissues do not reach the joint when taken orally, but are instead broken down in the digestion and metabolism, the sheer amount of claims for decades has led many patients into believing that they actually make their joints healthier and relieve pain when taken orally. This product also heavily marketed the idea that taking pills was difficult, and so a liquid supplement drink would solve this problem. Obviously, the belief generated by massive advertising works, and seems to produce a sizable placebo effect. The enforcement of this settlement, though, involves purchasers having to submit written claims on forms obtained from the company, and providing proof of purchase, by December 30, 2015, to guarantee reimbursement, and this before the final appeal is considered on February 22, 2016. If these claims are not submitted, the court has declared that the Class of purchasers involved in the lawsuit does not officially exist. The settlement needs to be advertised, and so full page ads are purchased in media such as National Geographic, where it will probably be ignored. In the meantime, the product continues to be sold and advertised as clinically proven to benefit joint tissues and relieve pain. Small companies that have made indirect claims on herbal and nutrient medicines, even when supported by clinical studies, have been routinely threatened and sometimes driven out of business by the FTC. Oversight of this biased system does not exist.
The actual safety of the herbal industry in the United States is remarkable, considering the lack of regulation. In 2000, the renowned Dr. James Duke, of the U.S. Department of Agriculture, noted that up to half of the American public utilized herbal medicine, but only 40 deaths were attributed to misuse of herbs in 1999, while prescription medications of pharmaceutical drugs are linked to between 80,000 and 120,000 deaths yearly. Even in Asia, the incidence of admissions to hospitals due to adverse reactions from herbal drugs is minimal, with studies showing just a little over 1 in 1000 admissions to hospital care related to herbal adverse reactions, whereas over 4 percent (1 in 25) of admissions were attributed for drug-related health problems. While much effort has gone into touting the potential contraindications between herbal medicines and pharmaceuticals, there have been almost no actual clinical cases proven involving these contraindications and harm. Many prominent University Medical Schools have now thoroughly investigated these reports of negative interactions between the handful of herbs always cited and pharmaceuticals, yet have found almost no actual evidence of clinical effects. These studies have been valuable, though, revealing the amazing variance between individuals of the rate of breakdown of pharmaceutical drugs and thus the wide variance in the circulating levels of active drug chemicals. It appears that most often, the standard dose does not reflect the eventual circulating levels, or accumulative levels of the drug. Not only the size and age of the patient, but the functional capacity of the liver system and sometimes the kidney function, creates wide variance, as well as the absorption in the gastrointestinal tract with illness. These studies have also highlighted the problems with pharmaceutical drug contraindications and interactions, and competition for the catabolic breakdown, with actual levels of drugs in the body varying widely at times when too many pharmaceuticals are prescribed. This information is still largely ignored, though, by standard medicine and the government regulation, as well as the public and patients, who are often negatively affected.
Due to this unregulated herbal industry in the United States, commercial herbal products should be highly suspect. For example, the marketing of herbal supplements for erectile dysfunction, or rather products promoted to increase the libido, promote erections, or even increase the penile size, are now a very popular product, heavily advertised on the television and in print. On February 13, 2012, the FDA submitted an alert, showing that 101 of these products on the market contain an unlisted pharmaceutical chemical, an analog of sildenafil (Viagra), tadalafil, or vardenafil, or other phosphodiesterase-5 inhibitor, and the FDA warned patients that these supplements may seriously interact with prescription drugs such as nitrates, like Viagra (sildenafil) et al. The products, called herbal and natural, are actually prescription Viagra or other drugs for erectile dysfunction, sold without a prescription. Despite the fact that manufacturers of these products were already convicted and imprisoned for fraud, the FDA did not stop the industry from blatantly selling prescription chemicals as herbal products. Many such commercial herbal and nutrient products are suspect in this regard. The public has only one apparent protection from this type of herbal product fraud, purchasing the herbal medications from a professional licensed herbalist, i.e. a Licensed Acupuncturist or Naturopathic physician. The industry itself shows very little cause for trust.
The public has little to depend on in this system. One manner of dependability, though, would be to see whether a professional herbalist, with a business license and education, is prescribing and distributing the product, and is taking care to obtain the product from manufacturers that produce quality assured products. A number of professional herbal and nutrient medicine producers are run by experienced medical professionals that insure that the right herb is obtained, that it is of high quality, and that it is tested for contaminants. These small professional companies also provide assurance that the extraction methods for specific chemicals are appropriate. Nutrient supplement manufacturers also may provide assurance to the prescribing physician that they maintain high standards. Most importantly, though, is the fact that the prescribing physician has used these products for years and witnessed the effectiveness and safety. This is the greatest public assurance.
A Case in Point
An example of the ongoing confusion and alarm sponsored and supported by the U.S. FDA is the 2015 case of the drug BMPEA (beta-mehtyphenylethylamine), an amphetamine derivative widely found in weight loss supplements marketed by the large drugstore corporations. A study of the chemical led by Dr. Pieter Cohen of the Harvard Medical School resulted in the Canadian health authorities declaring it "a serious health threat" and resulted in a recall of the diet supplement JetFuel Superburn. An investigation by the New York State Attorney General's office found 11 such weight loss supplements with BMPEA included in common samples of such formulas at popular drugstores and nutritional supplement stores, such as GNC, all without listing BMPEA on the label, and all including the herb Acacia rigidula. Of course, the story in the news implied that the chemical was from this herb, a native acacia shrub to Texas, but Dr. Cohen stated that acacia rigidula does not naturally contain BMPEA. Of course, other species of acacia are now well known to act as appetite inhibitors and are widely used in weight loss formulas, but are without adverse effects and contain no amphetamine derivatives, the same as acacia rigidula, which has not been well studied.
The chemical BMPEA was researched decades ago by the pharmaceutical industry, but only now surfaces, as a substitute for the banned fenfluramine and phentermine, the chemicals used in Fen-phen, which caused many tens of thousands of cardiovascular deaths with chronic use and was banned. Now, when fenfluramine, a synthesized amphetamine derivative created in the 1973, but not heavily marketed until the 1990s, was banned, here too the story ran, even from the U.S. FDA, that this was a chemical found in ephedra, a common herb widely used across the world as a bronchodilator and stimulant. The ban included the use of ephedra in supplements, confusing the public purposefully, and implying that the herbal industry was responsible, rather than the pharmaceutical industry, which created fenfluramine, and now BMPEA, and has reintroduced phentermine in new drug combinations for treating obesity, again approved by the FDA despite the history of adverse effects. The drug Fen-Phen, widely prescribed by medical doctors for weight loss, did not contain ephedra, and ephedra did not contain fenfluramine or phentermine. The herb ephedra, though, does not contain the active chemicals ephedrine, pseudoephedrine, epinephrine, and phenylephrine, all of which are chemically distinct from the synthesized fenfluramine, phentermine and now BMPEA, which are all very similar in chemical structure.
As the BMPEA study was published with warnings of potential adverse cardiovascular effects with chronic use the U.S. FDA did nothing. In fact, Dr. Cohen stated that he performed his study in response to the FDA doing nothing. The U.S. FDA stated that its director of dietary supplements regulation, Dr. Daniel Fabricant, had quit in 2014 to rejoin the Natural Products Association, a trade group involved in such over the counter supplements that continue to be mislabeled. His replacement is an acting director, Cara Welch, also a former employee of this industry trade group, and it appears that many of the appointed FDA officials in this realm are using a revolving door between the industry that produces these mislabeled and chemical-laden so-called natural supplement and herbal formulas and products, and the FDA that is supposed to be overseeing these same products, but refuses to adopt international standards of quality and inspection. This, like many other stories, will probably be reported in the most confusing manner possible to achieve various goals, mainly to alarm the public and discourage future trust in the professional herbal and nutrient medicine products. In the meantime, those who are interested must just continue to hope that the U.S. FDA doesn't continue to allow the drug industry to continue to falsely market herbal and nutrient supplements with potentially harmful chemical ingredients not listed on the labels, and when caught, just imply that the problems are related to legitimate herbal medicine.
An Alarming Rise in Emergency Room Visits in the United States from Poorly Regulated Dietary Supplements
In 2015, the U.S. Centers for Disease Control and Prevention and the FDA led a study that showed that the rapidly growing dietary supplement industry, now estimated at $32 billion per year, has led to more than 20,000 Emergency Room visits per year, mostly involving younger individuals purchasing poorly regulated energy drinks and weight loss supplements, as well as athletic performance enhancing supplements, containing nutrient and herbal chemicals. The report did not include statistics on mortality, but about 10 percent of these ER visits resulted in hospitalization. While prescription drug use results in over 30 times this many ER visits per year in the U.S., with many mortalities, this report does highlight the growing threat of poor regulated nutrient and herbal products, which are often shown to contain unlabeled drugs. The growing market of energy drinks and diet supplements marketed as "natural", but containing stimulants that may produce alarming effects, are particularly troublesome. This study showed that a large percentage of the ER visits occurred with individuals age 20-34, with over half of these cases caused by a supplement marketed as a weight loss supplement or energy enhancement, and producing alarming episodes of heart palpitations, tachycardia, irregular rhythms and chest pain. The researchers stated that these supplements, bought off the counter or on line, frequently contained toxic chemicals and unlisted stimulants, and caused cardiovascular problems even more often than prescription amphetamine-like drugs prescribed for weight loss and energy. Dr. Pieter Cohen, a professor at the Harvard Medical School, and one of the chief authors, stated in a New York Times article entitled Dietary Supplements Cause 20,000 E.R. Visits Each Year, Study Says, that: "What we're seeing from this study is that the system has failed. It's failing to protect consumers from very serious harm." Significant harm was also seen from older individuals choking on large pills, and allergic reactions. While this study shows that only about one tenth of one percent of customers went to the ER due to poorly regulated dietary supplements, the lack of regulation, the explosive growth in this industry, with almost all products bought without professional guidance, and the problems with over-the-counter or on-line products not containing what is listed on the label, and often containing unlisted pharmaceutical chemicals, as shown from the studies cited above, points to the need for the public to be wary of nonprofessional nutrient and herbal products, especially those marketed for weight loss and energy stimulation.
New Developments in Herbal Medicine
Many pharmaceutical medicines we use today were derived from herbal research, and some of the most effective medicines in the world are herbal, such as artemisinin, a widely used essential WHO drug for malaria, as well as the synthesized analogues that are also derived from natural sources, such as bacteria. Artemisin, and artemisinin, are merely standardized extracts from Artemisia qinghao, a common Chinese herb. Today, this herbal medicine is proven to be very effective to treat a variety of cancers, and even nervous system diseases. The Chinese discovered how effective it was, showing a 96 percent cure rate for malaria, and it was used and studied for this treatment since the 1970s extensively. In recent years, this research in the herbal chemical resulted in both the Lasker Award and the Nobel Prize for Medicine awarded. The pharmaceutical companies spent a lot of money and effort denying the world population access to this effective drug, though, and finally the Chinese developed an analogue form that could be synthesized from natural sources, but didn't patent it. Today, patented forms of this artemisinin anaologue create an enormous income for pharmaceutical companies based in the United States, but the medicines are not called herbal, and are combined with quinine derived drugs, which are from the herbal bark of a medicinal tree originally. Likewise, today, the pharmaceutical industry has developed statin drugs from Red Yeast Rice extract, a common nutrient in Chinese history for health benefit. Today, the Chinese have gotten smart, and are involved in a tremendous amount of herbal pharmaceutical development, with the most promising medicine, Celastrol, derived from a quinone triterpene obtained from either the herb Lei gong teng, or Trypterygium wilfordii, or Celastrus regelii, or lesser known herbal medicine. This herb, Lei gong teng, has been used for centuries successfully, and safely, and now has a history of at least 15 years of extensive research, including human stage 3 clinical trials of the standardized extract, proven very successful for the treatment of autoimmune disorders. Today, the Chinese have developed and patented a natural herbal analogue and called it Celastrol, and it has been proven very effective to treat autoimmune disorders, rheumatic disease, cancer and even obesity. Unlike new pharmaceuticals, this medicine will be delayed from the actual U.S. market for another decade while human clinical trials are financed and completed, even though they have already been performed, and no significant toxicity or adverse health effects noted. On the other hand, many new pharmaceuticals, with pages of adverse effects and toxicity, are fast-tracked, and heavily marketed, only to be withdrawn from the market in a few years when the long-term adverse health effects are seen. Other herbal medicines derived from Chinese herbs include resveratrol, which has been unsuccessfully synthesized as a patentable analogue by the pharmaceutical industry, only to find that side effects occurred with these synthesized versions, and they didn't work nearly as well as the standardized resveratrol from the herb Hu zhang, or Polygonum cuspidatum. When marketing resveratrol, the doctors used products that claimed that it was just a molecule derived from red wine polyphenols, but numerous studies show that it would take gallons of grape skin as red wine to make a single dose of resveratrol, whereas the amount in the Chinese herb is very high. The absurd level of duplicity and misinformation, and the apparent harm to public health, as these games continue, are amazing. If these herbal medicines were allowed to be developed and distributed as they deserve, the benefits to patients, and to the affordability of healthcare, would be enormous.
Information Resources and Additional Information
- The inadequate U.S. FDA explanation of the regulation of dietary supplements, which includes herbal and nutrient medicine, makes clear that they depend on companies to self-police their quality and report any adverse effects to the government! OMG! Even with the incredibly weak threat of taking some undisclosed action to punish companies for the numerous violations of dietary supplement claims and misinformation on the product label since this 1994 law went into effect, there has been a growing disregard for product quality in commercial products, apparently fearing no FDA action of merit. On the other hand, the FDA continues to harass small professional herbal manufacturers, with vague threats, getting them to dumb down labels and adopt ridiculous names for herbal formulas that make no sense at all to the patients, and raiding legitimate medical clinics and manufacturers in most egregious manner: http://www.fda.gov/Food/DietarySupplements/default.htm
- A further inadequate U.S. FDA explanation for writing another set of regulations in 2007 that was almost the same as the 1994 act, and cynically titled the Final Rule, settling for more self-policing of these products, but setting up a rare inspection of manufacturing products to see if the manufacturer has written explanations of their processes that match the production line, and responding to the complaints about Current Good Manufacturing Practice (CGMP) concerning the pharmaceutical industry applied to supplements, called the Dietary Supplement Current Good Manufacturing Practice (DS CGMP), which like the pharmaceutical guidelines, calls for self-policing and self-imposed recalls when necessary, and does not establish any legally enforceable responsibilities, only recommendations: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm238182.htm
- What are Current Good Manufacturing Practice (CGMP) guidelines? Check this out and see if you feel safe: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
- The U.S. FDA still allows many unsubstantiated products on the commercial market with unsubstantiated claims under a provision entitled the Generally Recognized as Safe (GRAS) ruling. Included are many drugstore products that were manufactured before the current regulatory rules of supplements, and make medical claims without even revealing what is in the product: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/
- A 1997 history of the U.S. FDA and its history of both attacking so-called alternative medicine, and failing to regulate or even distinguish real Complementary and Integrative Medicine from profiteering quack supplements, is presented here by the Harvard University's DASH repository (Digital Access to Scholarship): http://dash.harvard.edu/bitstream/handle/1/8852106/Tricia_M_Hwang.pdf?sequence=1
- A 2015 story in the Atlantic outlines the action in 2015 by the New York State Attorney General's office, issuing a cease and desist order against 4 major drugstore chains, Walmart, Walgreen, GNC and Target, to stop selling commercial herbal products that were found in an extensive investigation to contain none of the herbal extracts listed on the label when tested with DNA analysis. The investigation allegedly showed that about 80 percent of the commercial herbal products on these stores shelves did not contain any of the herbal extracts listed on the label, and many just contained filler material with no medical purpose. The story also outlines how a 1994 law sponsored by Senator Orin Hatch, who has long times to this commercial herbal and nutrient supplement industry, is designed to be inadequate to actually regulate and enforce this commercial industry, resulting in much manipulation of products: http://www.theatlantic.com/health/archive/2015/02/how-supplements-work/385119/
- A 2013 study of herbal toxicity by experts at Goethe University Frankfurt, in Main, Germany, noted that reports of liver toxicity with herbal medicines such as Kava and St. Johns' Wort have been highly disputed, and that an evaluation found that these have been based on faulty methods of validation of injury known as the WHO global introspection method, which is grossly nonspecific and lacks basic reliability as to specificity and sensitivity. In other words, the methodology by which most of these numerous published reports of liver toxicity by just a few herbs have been generated is not proving any specific harm or toxicity, "thereby stimulating case overdiagnosing and overreporting", according to the medical faculty at this prestigious European university medical school. These medical professors and researchers suggest that we use the Council for International Organizations of Medical Sciences protocol in future evaluations of herbal toxicity: http://www.ncbi.nlm.nih.gov/pubmed/23293189
- A 2012 assessment of reports of herbal toxicity, which involve only a few herbs, by the United States Pharmacopeia (USP), is shown to be at best faulty in its assessment, according to experts at the Goethe University Frankfurt Academic Teaching Hospital, and members of the Medical Faculty. The USP reports of liver toxicity from herbal medicines was based on a method that is not even liver specific, the shortened Naranjo scale, and thus were consequently considered invalid. Such reports of professional herbal toxicity are common, showing the enormous bias against the professional herbal medical field: http://www.ncbi.nlm.nih.gov/pubmed/22897137
- A 2010 report by the European Medicines Agency shows that there are no current studies of herbal medicines and reported "expiration dates" that are now imposed by the companies selling these products, as the complexity of determining the stability of the numerous herbal chemicals in products is too great. Nevertheless, a number of studies of the stability of herbal medicines have been conducted and shown that current methods of preservation with dried herbs, herbal pills, and extract tinctures extend the viability of these chemical medicines to a long time frame, and in fact, herbal extracts historically preserved in alcohol have been studied and shown to be chemically intake if preserved in a sealed container for many centuries. This report concludes that the current guidelines for determining stability and quality of herbal products is inadequate in design and feasibility, and that this presents "a major obstacle to the submission of applications to the THMRS", and "this obstacle is discriminating against herbal products", and is "clearly much more suited to single or very limited combinations of herbs". A new set of guidelines is needed to present guidelines in herbal medicine: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/11/WC500098815.pdf
- A list of documents from the European Medicines Agency regarding the present state of herbal medicine guidelines and quality assurance: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000365.jsp&mid=WC0b01ac0580029569
- The updated World Health Organization guideline recommendations for quality control of herbal medicines is summarized by Indian authorities, with emphasis that herbal products with synthetic compounds added, or even isolated constituent chemicals from herbal materials, are generally not considered to be actual herbal medicinal products, and that testing for contaminants is now the standard for herbal medicines due to the widespread use of toxic herbicides, pesticides and persistent organic pollutants that may accumulate, as well as the concern for production facilities and potential for aflatoxins from fungi and other growths that could present hazard. It is thus important to purchase herbal medicines from reliable professional sources:http://www.ijrap.net/admin/php/uploads/563_pdf.pdf