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    Pharmacy to the World

Herbal Medicine Versus The FDA

By Leslie Taylor 1/13/2013

Plants have been used for medicinal purposes long before recorded history. Ancient Chinese and Egyptian papyrus writings describe medicinal uses for plants as early as 3,000 BC. Indigenous cultures (such as African and Native American) used herbs in their healing rituals, while others developed traditional medical systems (such as Ayurveda and Traditional Chinese Medicine) in which herbal therapies were used.

The World Health Organization estimates that 80% of people worldwide rely on herbal medicines for some part of their primary health care. In Germany, about 600 - 700 plant based medicines are available (and manufactured only by pharmaceutical companies) and are prescribed by some 70% of German physicians. People throughout the world and in all cultures still use herbal medicine today, and they are using these herbal medicines to treat, prevent and cure diseases and conditions. That’s what “medicines” do.

There is an entire profession which studies these traditional uses of plants which is called ethnobotany. There are library shelves overflowing with their research documenting which people use what plants, what they use them for and how they are used. These researchers found that people in different parts of the world tended to use the same or similar plants for the same diseases and conditions... meaning there had to be a specific reason the same plant was used for the same thing continents away from each other. Pharmaceutical companies know that; a large number of educated and trained ethnobotanists are employed by pharmaceutical companies. These ethnobotanists look for plants that people use effectively for various diseases and conditions and turn them over to their in-house researchers in charge of new drug discovery. These guys are looking for novel and active plant chemicals in these medicinal plants which have biological activity that they can patent and turn into pharmaceutical drugs.

But if you’re an American, the Food and Drug Administration (FDA) wants to limit your access to this entire body of research and knowledge. The FDA has declared that there is no such thing as herbal medicine or medicinal plants; there are only foods and prescription drugs (they ARE the Food and Drug people so that’s the only definitions they ever created). Under the food category there are dietary and herbal supplements but the FDA has declared that this category of foods cannot treat, cure or prevent any disease or condition. The FDA has narrowly defined that this classification of food can only nutritionally support (as a food) the structure or function of an organ or a system. The FDA mandates the only claim allowable for dietary supplements are called “Structure-Function Claims.” One might read one of these “allowable claims” somewhere... This substance/product/herb/vitamin nutritionally supports healthy cholesterol levels. (But if I already had normal cholesterol, why would I need to nutritionally support that?)

But, as soon as a dietary supplement actually CHANGES the function or structure of an organ or system (say, by lowering cholesterol) or actually treats a disease or condition like high cholesterol, or someone who sells the supplement claims (even truthfully) it can treat a disease or condition, in the eyes of the FDA, that supplement automatically and instantaneously transforms to a drug. Worse; the person or company selling it now becomes a criminal by selling a unlicensed and unapproved drug and faces civil and criminal charges, fines, and even incarceration.

Here’s a great example of how this is supposed to work. There is a long history of use by people on almost every continent that prunes are a great natural remedy to treat and cure mild to moderate constipation (a health condition). I’ll bet even those 3,000 BC Egyptians knew it too. But if a company selling dried prunes, prune juice, or capsules containing dried prune juice actually says that truthful statement in their marketing materials, on their food labels, on their website, or refers in any way to this long established traditional use of treating or curing a medical condition, that food product is instantly transformed into a drug in the eyes of the FDA. Now that company is selling an unlicensed drug and subject to criminal and civil prosecution. The product in the eyes of the FDA is “unsafe” since there are no double-blind placebo clinical trials proving the safety and efficacy of prunes being used to treat or cure constipation.

So now prunes are a drug because some company said there was a long history of use of using prunes for constipation. You should get a prescription from your doctor for prunes to treat your constipation. But wait, first someone (stupid) has to conduct millions of dollars of clinical drug trials to prove that prunes will treat your constipation (despite the fact a billion people already know that) before anyone can make that claim or a prune drug is approved and blessed by the FDA. Maybe we should have drug warning labels on prune juice that say people without constipation might get diarrhea if they consume too much? But prunes are already in nature and cannot be patented. Who is going to spend $10 million dollars or more in clinical trials to prove to the FDA what we already know if any and everyone can then sell prunes with the now FDA approved drug claim that it can be used to cure, treat and prevent a condition like constipation? You got it - no one will. I’m sure the FDA would much rather you go to the drug store and spend your money on a FDA-approved, pharmaceutical-company-manufactured, over-the-counter chemical drug like miralax or ex-lax and avoid those unapproved and unsafe prunes all together. After all, the FDA is watching out for you, making sure you don’t do anything stupid or hurt yourself with that unlicensed and unapproved prune juice drug. Don’t you feel relieved that they got your back? Is it only me who thinks that the FDA is protecting the profits of the drug manufacturers selling approved drugs for constipation by silencing the truthful statements of companies selling prune products? I hope not. But that’s been the FDA’s operating model for many years.

In 1994 Congress passed a law intending to keep this kind of factual and truthful knowledge about the value and benefits of dietary supplements available to all Americans. This law was passed by a huge grass-roots movement because, even back then, the FDA was harassing dietary and herbal supplement manufacturers and marketers. This law was called the Dietary Supplement Health Education Act of 1994 (DSHEA). But then Congress had to turn that law over to the FDA to implement and regulate. The FDA, under their regulatory powers, has published hundreds of regulations (and enforces others that they never even bothered to published) since that law was passed. Most of these regulations have eroded or even evaporated your access to that body of knowledge and research on natural remedies and herbal medicine.

Up until around 2005, someone selling dietary supplements was allowed to refer to the traditional uses of plants under certain conditions. The Federal Trade Commission (FTC), who regulates the advertising and marketing of dietary supplements, even wrote a guidance document to the industry concerning when and how these traditional uses could be used. Basically it had to be factual and not misleading. It needed to be clearly indicated that the traditional uses referred to may not be, or were not, scientifically validated. And, it should only be used if the product being sold was prepared in a similar manner as the traditional uses described.

But here was the rub... these traditional uses were usually always for the treatment or prevention of some health condition or disease. With few exceptions, medicinal plants were, and are, used as medicines... not to “nutritionally support an organ or system” as the FDA has mandated can only be used in marketing dietary supplements. So people were educated and the dietary supplement industry grew larger. The timing of DSHEA was also around the beginning of the internet and educating Americans became more efficient and less expensive. Americans learned about natural remedies thru these long standing traditional uses and used them for themselves and they worked! God forbid, they might have even bought fewer prescription drugs if the natural remedies worked for them. The drug industry and the FDA hated that. Some time after 2005 the FDA put a stop to anyone referring to these traditional uses. They didn’t write up a regulation as they were supposed to do. They didn’t inform the industry officially or ask for feedback and comments as they are required. The FDA simply added it to their enforcement protocols. Supplement companies were inspected or their website was reviewed and the company was notified that they were selling illegal drugs by making illegal drug claims. The new unofficial (and unpublished) enforcement was this: traditional uses were now drug claims if the traditional use referred to treating any disease or condition. This superceded the FTC’s guidance and approval of referring to traditional uses when legally marketing dietary supplements.

The FDA basically changed the entire “Education” part of DSHEA since herbal companies were no longer able to educate anyone about the truthful traditional uses of a medicinal plant or their products containing those plants. Prunes were never used to “nutritionally support the colon” or “nutritionally support digestive and elimination systems.” Making those types of FDA-allowable statements would be false and misleading and it couldn’t be supported in any of the published literature (isn’t it the FTC’s job to protect us from misleading marketing?). Prunes ARE a natural remedy to treat constipation. There are tons of references in the published literature to that effect. But the FDA now says, despite DSHEA and despite the FTC, they are going to criminalize all the true facts of medicinal plants or anything natural treating any disease or condition and encourage misleading advertising claims of some kind of non-existent “nutritional support” instead. And they did this without issuing a single regulation, or announcing it or justifying it to anyone.

The FDA has superceded the intent of the law Congress passed and has overstepped its bounds. Every year they publish new regulations that further erode your right to factual information about how natural remedies can positively affect your health and limit what natural product manufacturers can say about their products. The FDA has lost in Federal court numerous times over their suppression of factual information about dietary supplements and unfair and unconstitutional regulations and practices. Even after they lose in court, nothing changes, and they continue the same enforcement protocols with a business-as-usual mentality. The FDA doesn’t really answer to anyone... not the House, not the Senate, not even the President. Sure, the President appoints the head of the FDA, but doesn’t have any legal authority over how he or she runs the FDA thereafter.

Someone on the Hill needs to get the FDA back to the basic tenets about what DHSEA was all about and prevent them from changing the laws that were voted on in this Democracy that we supposedly still live in. That law originally said Americans have a right to factual and non-misleading information on the health benefits of supplements. Where is that right today? The FDA has defined and regulated that law to oblivion. Someone on the Hill needs to make the FDA follow the regulations the FDA is required to follow. If the FDA decided a new regulation was necessary to outlaw 95% of the traditional uses of medicinal plants by calling them drug claims and supercede another agency like the FTC, then put it in the Federal Register where all new federal regulations are required to be posted and justify why it is necessary. Then, as also required by law, give the industry and the American people who are affected by this new regulation time to provide their comments (and outrage) before the regulation is passed (and Congress or even the FTC has time to intervene or provide input). This is supposedly our due process. Why can the FDA totally ignore due process?

Maybe it’s time for another grass-roots movement like the one we did back in 1994 to pass DSHEA. It seems this one needs to be an enforcement action to enforce the laws of our country onto the FDA. One to bring them back into compliance with the law and remind them what the intent of the DSHEA law was all about. They should not have the right or the ability to operate outside the law as they do.

Leslie Taylor 1-13-2013