Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -126

Accepted - Volume 2

Comment Record
Commentor Dr. barbara hernandez Date/Time 2002-06-17 16:56:49
Organization naturally healthy wellness ctr
Category Dietary Supplement Industry

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? 1. re; 1st amendments; labels should be required to show what the supplements supports, and containdications 2. for anyone to speak up about side effects of pharmeceuticals drugs, and the FDA really needs to heed warnings more closely. 3. Supplements are made from NATURAL products, whether or not they can be patented for profit by pharmaceutical companies, should not be a prerequiste for manufacturing these natural products. Herbs and natural ingredients are God's gifts to humans for food as stated in the Bible, 4. perhaps it is time to begin a new Governing body or regulating office to handle nothing but natural products, and supplements, allowing the FDA to continue working for the Drug manufacturers and their lobbies! the supplement industry is a $70 Billion market, by limiting a persons use, this is removing Freedom of choice by patients. thank you for my 1st amendment rights t speak my mind. Dr hernandez
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 will start by the potential risks by patients and their drugs consumed 1. it is my belief, for patients taking a variety of drugs daily, that over a long period of time, these drugs exasperate Alzheimers disease by sludge on the brain, from the body's inability to dicharge the synthetic principles of man made drugs from the cells, without proper elimination of these synthetics, the sludge rest in the brain cells. the rest is history! I do not believe the physicians inform patients enough when prescribing prescriptions, and they may not know themselves. for every drug prescribed for whatever symptom, the physicians need to evaluate the over all use of all drugs the patient is taking, along with ways to prevent the use for long term., perhaps through more widely use of preventative care. defintely, more education on the parts of physicians for preventative care and alternative means would be a majoy stepping stone for over all health.
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? these disclaimers could be quite lengthy in eagrds to claims made. Rather than claims to cure this or that, supplements could state just as the manuels do, benefitting one ailment, or another, by use through oral administration, and check for contrainidications before suplementing. not to be used with X,Y, Z drugs, contraindicated! in this order, a consumer would be wise to consult the labels. Many or Most physicians know little regarding nutrition, and especailly supplements, reason many consumers are confused which to take. There is not any profit in prescribing supplements, where with pharmaceutical co, the physicians get freebies, perks and possibly kickbacks. we consumers are wising up to these facts!
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? one such authority on these dsclaimers may be the NIH org. it may be a wise move to include more of these agencies viewpoints.
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? use of more physician knowledge and education in these areas, as more and more patients are requesting information from their doctors. as for product labels, perhaps having brochures hangng near a display would be helpful for looking up warnings at point of purchase.
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? as for greater Gov latitude, until consumers can feel confident their physicians understand supplements better, i doubt in my opinion, I would trust Gov to make any assertions over labels, simply from all the media stating the Fda working with Drug companies to prevent freedom of choice to a consumer to be able to buy a product that works! Like KAVA, this i sone product that works and with better eduation to the public could be used responsibly! Toomany drugs have horrendous sideefects effecting the liver, etc, so this does not make sense! most I would say, of consumer familiar with herbs, know a person should not take herbs every day. 7 days on, 7 days off, as the body builds resistance.
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? undermining the manufaturers speech, i would think so. In a free market as in America, the more information , the better for consumers. I don't believe it is the FDA's duty to regulate free speech regarding any product!
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? 1. FDA's speech Regulated ? Public health is by education, the more the better! FDA would be wise to open that up! other approaches would be to have manufatacturers educate the phsyicians, and boththe retailers, consumers!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? yes in my opinion, would be to allow more herbal supplements, the consumer wish to have, vs; drugs. Listening would be a great start! listening to the market, to consumers, more leeway for new , improved herbs, seperating pharmaceutical companpies away from herbal manufacturers, allowing more marketing of such, education of these, information in general! allowing more schools for education benefits of learning a teaching consumers. Education in general!

EC -126