Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -282

Accepted - Volume 4

Comment Record
Commentor Ms. Anush Kirakosian Date/Time 2002-07-30 07:18:59
Organization Concerned citizen
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? Yes. Pharmaceutical companies are now directly advertising their drugs to the consumer in print and electronic media. We are bombarded by tv commercials in the privacy of our homes by different drug companies making all sorts of claims to health, vitality and freedom from pain. But we know that all drugs kill by their very nature. On the other hand, I can't recommend that my mother take anti-oxidants to prevent cancer when everyone knows that they do. There is something really wrong here. I've heard that the fourth cause of death in the US is due to drug interaction of prescription drugs. That's pretty staggering. What are the statistics on people dying from ingesting a mixture of different foods in the form of phytonutrients or glyconutrients? There is no comparison. Drugs are against nature, they don't grow on trees. When animals get sick in the wild, they go and consume vegetation that heals them. They don't look for little white pills that someone made in a laboratory. I think that a lot of the drug claims are misleading because eventhough they have a disclaimer on the bottom of the screen, they show happy healthy people managing their ordinary lives because they took this drug. This is especially true, for cancer related drugs.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? I don't know what the current research data is on the advertisement and its effect. What I do know is that if doctors are given the freedom to recommend dietary supplements that allowed the body to correct itself, then less people would die from drug interactions and have less side effects as a result. When the labeling sais that the supplement or statement has not been evaluated by the FDA it carries weight with today's malpractice fearing doctors. People are taking too many antibiotics and drugs. Why not improve the immune system and prevent colds and flues and other illnesses rather than take all the drugs which lose their effectiveness when a person really needs it for a threatening condition. Lets allow the doctor and the patient to team up to discuss all the options that are available for the patient's well being, drug and dietary supplements. When I had cancer, I welcomed the morphine for the pain because there was nothing else available for me at the time. I'm thankful for it. But when traditional conventional cancer treatment wasn't available for me, it was my friends from church who came to my rescue and recommended dietary supplements that allowed my immune system to kick in and modulate and my body fought the cancer in the end. Why couldn't my oncologist or the different facilities I visited work in cooperation with the natural alternative sector to do what was in my best interest, ie save my life? Do you not care?
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? I think the FDA is messed up and confused about what is food and how it is defined and what is a dietary supplement. Genetically modified organisms are allowed to be sold on the retail shelf as food without the disclaimer from the FDA, but Garlic or Aloe Vera gets labeled that it has not been evaluated by the FDA. If conventional foods had all the nutrients that our bodies needed, then there would be no need for ditary supplements. So rather than trying to regulate dietary supplements, more emphasis needs to be placed on harvesting nutritioanally sound food that's NOT green harvested, grown in mineral rich soil without all of the toxins of pestisides. How much sicker would our socity be if we did not supplement our conventional depleted diets? My garlic supplement has on its label this statement:Supports Cardio-vascular Health* The disclaimer that this was not FDA evaluated makes me think that I've been lied to since 1978 (when I first started this brand of garlic). Should I sue them for misleading me? What about the history of thousands of years of people eating garlic and recommending it to their children and other loved ones. That should stand for something. I think that the labels should just say dietary supplement. Everyone on the planet knows the importance of them. The FDA needs to realize that consumers are smarter now and demand wellness products. Economists are predicting a paradigm shift. We are sick and tired of being sick and tired. No more regulation!
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? There shouldn't be disclaimers. It's food. Food is nourishment and essential for life. That doesn't nedd a disclaimer.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? For myself, if the FDA one day really did discover a supplement that had a lethal dose amount like drugs do, I would question its validity. You can't yell wolf at garlic and expect to be believed if the danger actully does show up one day. After seeing the same label warning on all supplements I've taken since 1978, I've become desensitised to them. I would not recognise an actual warning from the FDA if ever ther was one on the label.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? I know that there are labels on foods in the supermarket that say 0g sugar when there is maltodextrose in the ingredients and the FDA allows this. So how can I trust an agency that does not play fair? I read the ingredients and decide for myself what I am willing to ingest. No agency has the right to restrict our First Amendment rights.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? That's the old paradigm, -one drug, one use. When the body is doing the healing itself, you can't regulate it and say how it should heal. That's not possible. And that's what is so wonderful that the body can heal itself given the right raw ingredients. No amount of regulation of speech is going to stop this paradigm shift because the consumer mandate for supplements is already here. The act needs to be revised to reflect the current needs of the people. It's too old. Drug manufacturers, distributors and marketers promote their products to doctors, patients, hospitals and pharmacies. It would only be fair and right that dietary supplements be given the same freedoms speech.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? Whenever speech is restricted, society as a whole loses. I think that people should be given the facts and allowed to make educated decisions about their personal lives.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think that the FDA should be DEREGULATED and thus allow citizens to make their own decisions about what is in their best interest. Especially after 9/11, Americans value their freedoms. I do. Our First Amendment gives us the right of free speech which the FDA through heavy lobbying from pharmaceuticals tries to suppress. I am humbly grateful for my right to choose whatever dietary supplement I want to take without Big Brother telling me I can't. I CAN! I live in the US not some third world country! Allow individuals to make educated decisions about what is best for them. Empower them, not amputate below the hips. The DSHEA allows for consumers to request and receive scientific information regarding the health benefits of dietary supplements. Finally, the law recognizes that we consumers can think for ourselves. What a novel idea.

EC -282