Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -164

Accepted - Volume 4

Comment Record
Commentor Mr. Greg Brogdon Date/Time 2002-07-25 11:50:16
Organization YMCA
Category Health Professional

Comments for FDA General
Questions
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? Dear Senators, I’d like to express my views concerning docket 02N-0209 & article 4 of Senate Bill SB 1750 on Dietary Supplements. I can appreciate the concern for safe and effective use of Dietary supplements and the need for regulatory issues concerning their use. However, we need to be cautious that what we put into play does not become a detriment to what our objectives are. As you know the Dietary Supplement Health & Education Act of 1994 was unanimous not just in congress, but was also the 2nd largest public outcry other than the Viet Nam war! The need for effective dietary intervention was at the top of the U.S. Congress list and represented the immediate need to reduce our nations rise in illness, disease and health care cost (1). As part of the baby boom generation I assure you I am a strong advocate for Integrative Medicine! So much so, that after my mother’s death from cancer and my daughter’s treatment on Dialysis after pharmaceutical medications destroyed her kidneys, I’ve devoted my life to the saving of others. My vote will reside with those that share my views as well. My message to you is this. I hope that in your consideration for complementary care treatments, you not become blinded to what big business is doing. The Pharmaceutical industry is killing over 144,000 Americans each year (JAMA). The treatments of many of our diseases are being conducted by the subsidiaries of the very companies that caused them to begin with. Our current “health care” system is a fraud! We do not get treated for a disease until we have one. Then we are treated for our symptoms with toxic pharmaceutical medications. The root cause of disease is nutrition or the lack thereof (2) (4). Unlike pharmaceuticals Functional Foods or Nutraceuticals are natural non-toxic food supplements with scientifically proven benefits. They support normal physiology and nutrition, the root causes of disease (2). Please make sure that you hold the pharmaceutical industry accountable just as you would the supplement industry. In so doing, remember there is a much greater risk to the public with pharmaceutical medications than supplements (3). To ensure safety issues concerning the sale and use of Nutraceutical Dietary Supplements, many companies have adopted pharmaceutical training &/or the use of pharmacy technicians for their distributors and clients. This type of measure would be an affective means to insure public safety as well as educational criteria needed to safely and effectively distribute supplements. Information about these programs can be found online at www.dotell.com/ana I appreciate your concern and support for the health and wellbeing of the American people. Sincerely, Greg Brogdon Reference: 1) DSHEA the Dietary Supplement Health & Education Act Oct 25th 1994 Public Law 103-417 103d Congress. 2) Glycoscience website Why Nutrition www.usa.glycoscience.com 3) Glycoscience website A Toxicologist’s Perspective www.usa.glycoscience.com 4) Glycoscience website Chemicals, Drugs and Nutritional Supplements–What are the Distinctions?
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? See above response I hope that in your consideration for complementary care treatments, you not become blinded to what big business is doing. The Pharmaceutical industry is killing over 144,000 Americans each year (JAMA). The treatments of many of our diseases are being conducted by the subsidiaries of the very companies that caused them to begin with. Our current “health care” system is a fraud! We do not get treated for a disease until we have one. Then we are treated for our symptoms with toxic pharmaceutical medications. The root cause of disease is nutrition or the lack thereof (2) (4). Unlike pharmaceuticals Functional Foods or Nutraceuticals are natural non-toxic food supplements with scientifically proven benefits. They support normal physiology and nutrition, the root causes of disease (2). Please make sure that you hold the pharmaceutical industry accountable just as you would the supplement industry. In so doing, remember there is a much greater risk to the public with pharmaceutical medications than supplements (3). To ensure safety issues concerning the sale and use of Nutraceutical Dietary Supplements, many companies have adopted pharmaceutical training &/or the use of pharmacy technicians for their distributors and clients. This type of measure would be an affective means to insure public safety as well as educational criteria needed to safely and effectively distribute supplements. Information about these programs can be found online at www.dotell.com/ana I appreciate your concern and support for the health and wellbeing of the American people. Sincerely, Greg Brogdon Reference: 1) DSHEA the Dietary Supplement Health & Education Act Oct 25th 1994 Public Law 103-417 103d Congress. 2) Glycoscience website Why Nutrition www.usa.glycoscience.com 3) Glycoscience website A Toxicologist’s Perspective www.usa.glycoscience.com 4) Glycoscience website Chemicals, Drugs and Nutritional Supplements–What are the Distinctions?
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? Unlike pharmaceuticals Functional Foods or Nutraceuticals are natural non-toxic food supplements with scientifically proven benefits. They support normal physiology and nutrition, the root causes of disease (2). Please make sure that you hold the pharmaceutical industry accountable just as you would the supplement industry. In so doing, remember there is a much greater risk to the public with pharmaceutical medications than supplements (3). To ensure safety issues concerning the sale and use of Nutraceutical Dietary Supplements, many companies have adopted pharmaceutical training &/or the use of pharmacy technicians for their distributors and clients. This type of measure would be an affective means to insure public safety as well as educational criteria needed to safely and effectively distribute supplements. Information about these programs can be found online at www.dotell.com/ana I appreciate your concern and support for the health and wellbeing of the American people. Sincerely, Greg Brogdon Reference: 1) DSHEA the Dietary Supplement Health & Education Act Oct 25th 1994 Public Law 103-417 103d Congress. 2) Glycoscience website Why Nutrition www.usa.glycoscience.com 3) Glycoscience website A Toxicologist’s Perspective www.usa.glycoscience.com 4) Glycoscience website Chemicals, Drugs and Nutritional Supplements–What are the Distinctions?
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? The DSHEA put into play the proper authority & use of supplementation by defining Peer Review Science for credidability & effecacy. As a Dietitian, I know the body needs FOOD not poison (pharmaceuticals) to heal & sustain life!
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? Peer Review Science for credidability & effecacy. To ensure safety issues concerning the sale and use of Nutraceutical Dietary Supplements, many companies have adopted pharmaceutical training &/or the use of pharmacy technicians for their distributors and clients. This type of measure would be an affective means to insure public safety as well as educational criteria needed to safely and effectively distribute supplements. Information about these programs can be found online at www.dotell.com/ana
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? The same for drugs: PDR for non-prescription drugs, peer review studies, Medline searchs, NIH & other government sites. Please read: Reference 1) DSHEA the Dietary Supplement Health & Education Act Oct 25th 1994 Public Law 103-417 103d Congress. 2) Glycoscience website Why Nutrition www.usa.glycoscience.com 3) Glycoscience website A Toxicologist’s Perspective www.usa.glycoscience.com 4) Glycoscience website Chemicals, Drugs and Nutritional Supplements–What are the Distinctions?
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? Empower the public through regulatory issues such as To ensure safety issues concerning the sale and use of Nutraceutical Dietary Supplements, many companies have adopted pharmaceutical training &/or the use of pharmacy technicians for their distributors and clients. This type of measure would be an affective means to insure public safety as well as educational criteria needed to safely and effectively distribute supplements. Information about these programs can be found online at www.dotell.com/ana
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? I believe they do for the most part. Drugs each have a LD 50 rating which 99% of our population dosen't understand! This means Lethal Dose 50%. All drugs must kill in order to become a drug! Food sustains life. Nutraceuticals are functional foods to aid the body
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Continue with what DSHEA put into effect the use of supplementation by defining Peer Review Science for credidability & effecacy. As a Dietitian, I know the body needs FOOD not poison (pharmaceuticals) to heal & sustain life!




EC -164