THE FDA, NUTRITIONAL SUPPLEMENTS AND MIND MACHINES. 9/15/92 There are four letters in this posting. Possibly you should just send the whole thing to your printer and then read it at your leisure, you will want to keep the names and addresses for future reference. 1.) A description of the FDA's proposed regulations as laid out by the National Health Alliance (NHA). 2.) A plea from the NHA that you write your congressmen. 3.) Sample letters to handwrite to your congressmen. 4.) A personal letter from me, if you can't stomach virulence just skip it. 5.) A personal letter from a friend who sells mind machines. I apologize for posting this all over the net, but sometimes you gotta interrupt the scheduled programming with important late breaking news. All flames to me, PLEASE DO NOT respond to the list that you read this on. Homer Wilson Smith, homer@rahul.net Disclaimer: My opinions are my own and do not represent those of my employer or of Cornell Univeristy. THE FDA'S CAMPAIGN TO TAKE AWAY YOUR FAMILY'S HEALTH CARE RIGHTS. Enclosed is information regarding the legislative action affecting the dietary supplement industry, the natural health care community and our right to choose wellness over illness. The three main areas that require attention are as follows: 1. The Nutrition Labeling And Education Act of 1990 2. Dietary Supplement Task Force Report 3. The FDA Enforcement Amendments of 1991 (HR 3642 & S 2135) Nutrition Labeling And Education Act (NLEA) In an attempt to provide the American public with information regarding the health-promoting benefits of foods, Congress enacted the Nutrition Labeling And Education Act of 1990, instructing the FDA to develop guidelines for how health claims can be made on food products. FDA has proposed regulations that will do the following: Disallow health claims for fiber, anti-oxidants, unsaturated fatty acids, zinc, etc. Lower RDA's from 10%-80%, reclassifying them as RDI's (Recommended Daily Intake). Dramatically reduce the potency of vitamins and minerals, REGULATING HIGH POTENCY VITAMINS AS DRUGS. Eliminate supplements such as bioflavonoids, rutin, PABA, selenium, inositol, chromium and other "nutritional substances." Eliminate herbs from the definition of "dietary supplement," thus regulating them as drugs. Consider any educational material, whether product specific or not, to be considered a third-party endorsement, and therefore any referral to a book may be considered a drug claim. Restrict the use of truthful educational material in the promotion of dietary supplements. Dietary Supplement Task Force Report In addition to the NLEA regulations, the FDA Commissioner David Kessler convened a Dietary Supplement Task Force to determine how supplements could be better regulated. Preliminary discussions with members of the task force have revealed the following: Dietary Supplements will be categorized in three classes: Category 1: Potencies of multi-vitamins and multi-minerals. Potencies of dietary supplements will be no higher than those found in foods. Category 2: Amino Acids, with recommendations that they be changed to prescription only. Category 3: All others will be available only by prescription, including herbs, specialized vitamin and mineral products, etc. The FDA Enforcement Amendments of 1991 (HR 3642 & S 2135) These proposed laws are designed to provide the FDA with a considerable amount of increased authority for taking action against products without "due process of law." The FDA will have the ability to embargo products, stop importation of herbs, levy fines of up to $250,000 per infraction for individuals and up to $1,000,000 per infraction for corporations, and subpoena records without court supervision. No other agency has been given such broad and constitutionally questionable powers. The House version is sponsored by Congressmen Waxman and Dingell, the Senate version is sponsored by Senator Kennedy. Because of the inherent bias the FDA has historically shown against herbs and the dietary supplement industry, we have no doubt that they will use these increased enforcement authorities to take unwarranted action. In preparation for increased enforcement activities, the FDA has hired 100 criminal investigators led by a 20-year veteran of the U.S. Secret Service. For more information contact the Nutritional Health Alliance, PO 267, Farmingdale, NY 11735, (516)-249-7070. Nutritional Health Alliance Protecting Your Right to Choose P O Box 267 Farmingdale, NY 11735 516-249-7070 August 31, 1992 Dear Health Food Industry Member: IT'S TIME TO ACT. Gary Dykstra, FDA Deputy Commissioner, made the following statements at the NNFA Show in Nashville: "As most of you know already, and it's not been a well kept secret, the Task Force is going to recommend in its report that amino acids be regulated as drugs." "With regard to taking actions against herbs as drugs or as new drugs, we continue to do that on a case by case basis..." "The Dr. Wright situation out in Seattle, I don't want to get defensive about that. Obviously we felt that we did the right thing." The handwriting is on the wall. The FDA intends to eliminate the dietary supplement industry as we know it. * The NHA is moving forward rapidly. The Hatch Bill, S 2835, is in the Senate expecting committee consideration and the Richardson Bill, HR 5746, is progressing in the House. It is URGENT that you support these bills with letters and phone calls immediately. WE ONLY HAVE FIVE WEEKS TO ACT BEFORE THE END OF THIS SESSION OF CONGRESS. * The NHA has its own team of experienced legislative activists working full time with our legislators in Washington. * The NHA has hired one of the top PR firms in the country, Rogers and Cowan, to bring our message loud and clear to all concerned citizens in the United States. * The NHA has just created a toll free legislative up-date hot line (1 800-226-4NHA) to keep you currently informed about the Health Freedom bills, the FDA enforcement bills, nutritional labeling issues, and other important legislative and regulatory news. Please call us today. Let us hear from you with your questions and recommendations. WE ARE HERE TO SERVE YOU. The Nutritional Health Alliance represents thousands of health food stores, hundreds of manufacturers, and thousands of health care professionals. Most importantly, the NHA represents YOU and the 80 million Americans who enjoy the freedom of choice to take dietary supplements. WE NEED YOUR FINANCIAL SUPPORT TO PROTECT YOUR RIGHTS AND YOUR LIVELIHOOD. IT IS TIME TO ACT. Even if you have sent in letters in the past, for the next five weeks send in ADDITIONAL LETTERS. Call and visit your senators and representatives. Ask them to co-sponsor the Health Freedom Bills in their house. Motivate your customers to write letters and make phone calls. It may well be now or never. Join our fax network and receive updates by fax twice a week. These fax updates are suitable for posting in your store and reproducing as handouts. The NHA continues to dedicate its resources where they are needed most and can produce the quickest and most effective results. A financial report summarizing our activities is available. Remember, the NHA is a cooperative alliance of our industry, by our industry, and for our industry to protect your rights to choose wellness over illness. The NHA represents your interest on both state and federal levels. WE ARE HERE TO SERVE YOU. Sincerely yours, Nutritional Health Alliance Gerald Kessler, President ARE YOUR NUTRITIONAL RIGHTS WORTH FIVE MINUTES OF YOUR TIME? YOUR LETTERS COUNT! WRITE TODAY TO PROTECT YOUR RIGHTS. Handwritten letters are the most powerful. Sample Letter For Congressmen: ------------------------------------------------------------------------ Representative's Name U.S. House of Representatives Washington, DC 20515 Dear Representative: Protect my health care rights! Please support Congressman Bill Richardson and the Health Choices Freedom Act of 1992 (H.R. 5746). Please let me know the action you are taking in order to protect my health care rights. Sincerely, John Q Public (signature) John Q. Public Your address City, State, Zip ------------------------------------------------------------------------ Sample Letter For Senators Hand written letters are the most powerful. -------------------------------------------------------------------------- Senator's Name U.S. Senate Washington, DC 20510 Dear Senator: Protect my health care rights! Please support Senator Orrin Hatch and the Health Freedom Act of 1992 (S. 2835). Please let me know the action you are taking in order to protect my health care rights. Sincerely, John Q Public (signature) John Q. Public Your address City, State, Zip -------------------------------------------------------------------------- TO FIND THE NAME OR TO DIRECTLY CONTACT YOUR LOCAL REPRESENTATIVE OR SENATOR, CALL THE CAPITOL SWITCHBOARD AT 202-225-3121. IMPORTANT! HANDWRITTEN LETTERS IN YOUR OWN WORDS ARE MUCH MORE EFFECTIVE THAN FORM LETTERS AT CONVINCING ELECTED OFFICIALS OF YOUR SINCERITY AND INVOLVEMENT WITH AN ISSUE. THE FDA, NUTRITIONAL SUPPLEMENTS AND MIND MACHINES. Homer Wilson Smith The FDA is planning one of the scariest attacks on your personal freedom and well being that has ever come down the pike, and the scariest thing is, is that it will probably pass without anyone knowing about it until it is far too late. You think the evening news has your best interests in mind? They exist on the advertising revenues for drugs and alcohol, you ever see an ad for multi vitamins or Niacin during prime time live? In fact, the new laws HAVE ALREADY BEEN PASSED AND ARE SOON TO GO INTO EFFECT but if you act now, and I do mean right now, you might be able to help countering legislation go into effect that will protect your rights and freedoms which the FDA and the American Medical Association and the other purveyors of drug and medicine addiction are planning to take away from you and your children. This is all described in the preceding articles in clear detail, and you should read every word of them, and then write and fax the hell out of your representatives in the House and the Senate letting them know just where you stand on the subject of your health. Put bluntly what the FDA wants to do is ban the sale of nutritional supplements, like vitamins and herbs and amino acids, except those that contain no more than what can be found in natural foods. They wish to regulate high potency vitamins, B-100's, A 10,000's, E 1000's, C 1000's, D 400's, and NIACIN 100's, etc as DRUGS, subject to the laws governing narcotics and criminal possession thereof. Such high potency supplements would only be available by prescription from a doctor, that you would have to PAY to visit and get that prescription, and you would only get it for as long as the doctor said you could have it. If he thought some of his higher priced, medicines were more suitable for you, well then he could take you off of A, B, C, D, E, IODINE, NIACIN, CALCIUM and MAGNESIUM, and put you on something more reasonable like THORAZINE, LITHIUM, VALLIUM, PROZAC, CHLORPROMAZINE and other stuff that God meant only for monsters. All herbs would also be regulated as drugs, lest anyone get well or stay well growing something that didn't generate a tithe to the almighty drug companies and Eli Lily. Whatever happened to growing your health in the back yard? Whatever happened to allopathic and homeopathic medicine, what ever happened to traditional wisdom on the subject of health care, disease prevention and cure? Do you REALLY think that some guy in a white coat making $150,000 a year knows more than your 90 year old grandmother about how to live long and prosper? Or is their whole game to suppress the symptom with some crazy drug and charge a buck for it? Have we all become computer robots so that only the assigned and certified technicians of the body are allowed to dispense cures and biochemical alignment and peace? Vitamins, as you all know, are not produced by the body. Dogs for example can produce their own vitamin C, but humans can't. Ever try feeding an orange to a dog? Well my Joey would eat grapes... Anyhow, the B vitamins are used to catalyze the burning of ATP and act as an important part of the energy cycle. Vitamin E is an anti-oxidant to keep everything else from turning rancid in your body, and Vitamin C is used to help you clean out all the toxins from your body. Smokers by the way have a much higher need of Vitamin C than non smokers. Niacin, a B vitamin, is one of the most amazing substances known to man, if you haven't tried it yet, GO DO IT. If you are trying to get off of cigarettes, niacin might help as it is related to nicotinic acid. Niacin of course must be taken with a balance of the other vitamins and minerals and iodine. Calcium and Magnesium are critical to the functioning of the nervous system and the bone and teeth structure, and often a deficiency of either will cause a person to be on edge continually. Anyhow, this whole god damn world is so polluted, the air is so disgusting, the water so foul, and the quality of food is so depleted and POISONED, considering how much processing it goes through to get from there to here, that there is just no way normal doses of vitamins are sufficient for many people to survive on this planet. One whiff of car fumes and I am dying like you wouldn't believe, I mean it can ruin my entire day. I used to be a heavy smoker, until I quit, using A, B, crystal C, D, E, Iodine (from tincture), Niacin and minerals. Gee and I though Iodine was POISONOUS! Well don't go drinking the entire bottle. Just use 3 drops in orange juice with a teaspoon of CRYSTAL C ALREADY mixed in it. Just the reaction of the C and the iodine is a wonder to behold, you just KNOW it's gotta be good for you. Don't forget to take A, B, D and E along with it. Niacin in fact saved my life, along with Iodine and other minerals. I would be dead if it weren't for niacin. The DOCTORS wanted to cut me open and do surgery on my spine! That would take care of the pain they said. Right. Now there is another aspect to this, and that is mind machines and bio feedback devices. Again the AMA doesn't want anything to make you well, stimulate your mind, raise your consciousness, tingle your toes, or just make you feel better, that you can just go buy in a store. Or worse design for yourself on a work bench. The FDA wants to either ban these machines outright, or make their approval process so impossible that none would remain on the market. They want you to PROVE the efficacy of such bio feedback and other mind machines before they are allowed on the market, as if inner well being can be proven to a jerk in a white coat. Besides you gotta be a human being before you can recognize that someone else is doing better in life. Anyhow, the FDA has already gone through this process with the Scientology E-meter and they lost that battle hook, line and sinker. But did they learn anything from that experience? NOOOOOOOOO!. Except how dangerous freedom of religion is along with the freedom to know about yourself and do what you can to improve your own life WITH YOUR OWN HANDS. So now they are trying for another stab at the mind machine market by going after everyone else. I mean are we cattle in their genetic breeding farm? Are they afraid we might harm ourselves and ruin their plans for world conquest through making a buck if we looked into our own well being and took some responsibility for what we want to ingest or take into our own bodies? What would happen if all the cattle in the world just up and said 'No more hormones!, we are going to eat what we want to eat!' Would the economy go under? Should we all just shut up and take whatever the government in its almighty wisdom and CARING feeds us? You know people are always pointing out, 'Well if you just let people do whatever they wanted to, just whatever came into their little ole heads, they would just eat sugar and candy all day long you know, and then turn to drugs and other horrible things and the whole world would just go to pot!' You want to know what the world's biggest addiction is? DOCTORS. This is deadly serious business. In my personal blind, ignorant, biased, and prejudiced opinion the FDA, the AMA, the WHO and the NIMH couldn't give a damn about your health or your well being, they care only about their own power and the pocketbooks of their masters. Entire companies will go out of business if these laws are allowed to pass or stand, populations will be at the mercy of the AMA quacks and psychiatric drug dealers, and free thought and experimentation on the subject of health and inner well being will become criminal by law. You want this? Well read on if you don't, and for heaven's sake write your congressman today, fax them, tell them what you think, give them a piece of your mind. If enough people give their congressmen a piece of their mind, maybe they will have a mind too! And by all means redistribute this posting to as many people as you can who might care about our freedoms and personal free choice in this matter of our physical well being. I am sorry if this posting has been a bit hysterical or off the wall, but hell I have a reputation to upkeep. Besides some of my best friends are doctors. And now that I have written this, I guess I should consider making friends with a few lawyers too, eh? Homer Wilson Smith HEALTH FREEDOM IN AMERICA 1992 KEY POINTS USUALLY NOT DISCUSSED. This is written as an addendum to pro-choice discussions about health freedoms which, it is assumed, properly speak for free choice of dietary supplements and properly identify the pending legislation worthy of attention. This document is intended to do 2 things only: (A) Point out how important it is to frame the issue as a matter of Minority Rights and tolerance of diversity and (B) point out how important it is to preserve protections not only for vitamins and dietary supplements but also for harmless devices. Health Freedom must be discussed as what it is if the communication is to be effective: It is an issue of minority rights. It is not an issue about consumer protection, nor is it an debate about the validity of health alternatives. The FDA can counter many of our opinions. It cannot counter our primary point: that the FDA will not tolerate minority views. It decides what is legitimate and what is not, and it will not allow products used by people holding dissenting views about health and medicine to be marketed. If the issue is discussed in these precise terms only, the grassroots support for freedom will be enormous, and we can defeat these important erosions of our basic freedoms. Currently, the FDA forbids treatments and products which it deems unsupported by "scientific consensus" not just over questions of safety but also EFFICACY as determined by the FDA. MANY Americans disagree with the FDA's reading of what is a "scientific consensus" particularly regarding efficacy, and our rights to access alternatives we value are already compromised. The FDA tends to function in a way that enforces a monopoly. This monopoly defines the kind of medical care available in the USA. In the name of consumer protection, providers of any alternative medical care, dietary supplements and health-related devices are sometimes already, and in the future may be more fully and frequently forced to prove efficacy to the FDA, a prohibitively expensive and time consuming process except for large, well financed corporations. If alternatives are marketed without such approval, the FDA can enforce its prohibition of alternatives without affording the providers of alternatives "due process". There exists a "revolving door" between the medical/pharmaceutical industry and the FDA. FDA personnel tend to be hostile to healthcare alternatives that don't come out of the mental set which they share with the "orthodox" medical community. They are blind to these biases, and they freely enforce these biases to the point of prohibiting access to alternatives they frequently do not understand. New legislation threatens to increase FDA regulation & harassment of alternative healthcare providers and companies making and selling dietary supplements and devices. Other new legislation may help safeguard access to alternative choices. This is extremely important legislation. The primary supporters of the objectionable legislation have been liberal Democrats (Waxman, Dingell, Kennedy & Metzenbaum) and the primary opponents of the objectionable legislation (and primary sponsors of the protective legislation) have been conservative Republicans (Hatch). This does not set out an appropriate position for progressives (liberals and Democrats). It is critical that Democrats publicly break with Waxman, Dingell, and their anti choice legislation and anti choice influence in Congress. Countless voters care deeply about this issue & the pending legislation. Because it is a deeply-felt issue, having to do with key choices about our own bodies and well- being, it is highly emotional, and it will politicize many successful, articulate people. It will build as an issue & it won't go away. Devices are very important, too. As our view of the human body includes more and more awareness of electromagnetic mechanisms and "energy" we will want to approach our own health not just via chemistry but through physics. Physics means devices. Devices which are (1) non- invasive and safe, and which (2) are not claimed to cure disease conditions, need to enjoy protections similar to those we have won for vitamins and are working towards for all other dietary supplements. If this is left out of our protective legislation, then we'll have missed an essential dimension of our needed protections. 20 years ago the Proxmier Amendment left out protections for various dietary supplements when it protected vitamins, and now we are having to fight for our basic rights yet again because of this omission. Devices will be the next "hole" in our rights if we don't get them protected now.