Update 5 May 07: This from the OCA:
ANSWER FROM OCA: There is only one group that has launched an alert on this issue, while all other health freedom groups have taken a more reserved stance. After much research and discussion with our allies in the alternative health world, it is the opinion of the OCA that although this FDA Guidance Document deserves attention, it does not change any laws that are already in place, and, in fact, serves as a distraction from some of the more important issues currently going on in regards to alternative health care regulations.
Do you use herbal products with your children? We do. I can’t imagine getting through a winter without elderberries and echinacea, but that is what the FDA would like us to do. It seems like every couple of years, this issue comes up, and I remember about ten years ago stocking up on echinacea seeds in defense. Once again, the FDA is attacking complementary and alternative health care. You can read the new proposed regulations here.
My herbalist friend Liisa of BellaBotanica alerted me to this important issue. She writes, “Please read and sign. You might soon have to go to the doctor for a prescription of vitamin C. This is for real. Emergen-C packets of 1000mg would have to be prescribed by doctors, and your lovely sweet smelling Lavender essential oil would too. This is ridiculous and the list goes on. Are you getting what this will cost us to simply take care of ourselves and practice preventative medicine? Actually I should call it preventative health care. Since “caring” is not a felony yet. This is not right. Help! Please take action and a moment to sign it.”
Dr. John Gilbert writes, “Essential oils, herbs, herbal remedies, homeopathic remedies, minerals, nutritional supplements, plant enzymes and vitamins are redefined in this
proposal as “medicine.” Very simply, medicine is under the
jurisdiction of the FDA and, by law, only licensed medical doctors may
prescribe “medicines.” Anybody else who advises, advocates, counsels, distributes, markets, recommends or suggests anybody use “medicine” is practicing medicine without a license. This is a felony in the USA punishable by fines and incarceration. Aromatherapy, auricular therapy, biofeedback, color therapy, homeopathy, hypnotism, naturopathy, neurotherapy, nutritional consulting, reflexology, sound therapy and wellness consulting are among the alternative health modalities being redefined as “Alternative Medicine.” This subtle change of vocabulary from “alternative health care” to “alternative medicine” makes all of these industries subject to control by the FDA as medicine. Only medical doctors would be allowed to provide, prescribe and supervise the delivery of these services. Anybody else who provided any of these services would be practicing medicine without a license and subject to incarceration and fines.”
You have until April 30th to sign the petition or make comments. You can also find out more information from the Natural Solutions Foundation.
Jennifer Lance says
I’m a researcher who works professionally on herbal medicines. While I’m no fan of the FDA’s past attempts to ban herbs, this proposal is not an attempt to overturn DSHEA (the 1994 law protecting supplements) by fiat. It’s mostly an attempt to assert control over products such as acupuncture needles or the variety of gadgets marketed for for alternative diagnosis or treatment (some of which are frank scams and ought to be banned). Under the present regulatory regime, if your individual echinacea or elderberry product states (truthfully!) that it may relieve colds and flu, it will be banned as a “misbranded new drug.” However, other manufacturers’ products that abide by DSHEA’s limits on “structure-function claims” and simply state that the product “helps support a healthy immune system,” leaving you to figure out from books or the internet what it is really good for, would remain legal dietary supplements. This proposal’s treatment of dietary supplements exactly follows DSHEA. It is not an ideal law, but it has been livable for 13 years and was written to protect traditional medicine, not suppress it. This guidance document specifically says that while a cranberry product claiming to prevent UTIs would be an illegal drug, the identical product marketed to “maintain urinary health” would be a legal supplement. During the Kessler era at FDA, their position was that the very fact that the supplement could prevent UTIs, even if it made no claims at all, justified confiscating it from the public. Thus the urgent need for DSHEA. I hope people will not overreact to this and deluge FDA with angry emails. Frankly, some bureaucrats appreciate any shred of evidence that supplement users are “confused” about any issue, because in the long term it bolsters their case that we are too stupid to make our own health care choices. So let’s not panic before we need to!
Jennifer Lance says
Thank you for sharing your perspective.