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"DHEA Dehydroepiandrosterone (DHEA) is marketed as an antiaging pill, which, thanks to some fancy footwork in Congress (the dshea, or the Dietary Supplement Health and Education Act, as explained earlier), is available over the counter. DHEA declines with normal aging. Since DHEA blocks the effects of stress hormones like Cortisol and has a protective effect on neurons in animal models, it has been described as an antistress and antiag-ing hormone. DHEA, since it is a precursor of testosterone, is being used by athletes to build muscle mass, but it is not very effective for this purpose." - J. Douglas Bremner, Before You Take that Pill: Why the Drug Industry May Be Bad for Your Health (Get the book.)

"While dshea did legislate FDA oversight of these products, the rules governing their use are extremely liberal. Since evidence of effectiveness is not required, the only rule is that nutraceutical manufacturers can't make health claims about their products. So marketers have to be careful not to say that their product can relieve symptoms such as fatigue or pain. Doing so without evidence and FDA approval is illegal, although a glance at just about any health magazine shows ads that do make substantial health claims." - Benjamin H. Natelson, M.D., Your Symptoms Are Real: What to Do When Your Doctor Says Nothing Is Wrong (Get the book.)

"The dshea also dramatically reduced the FDA control over dietary supplements. Under the dshea, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Just like drugs, the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"Congress in its dshea Senate Report also made clear the congressional understanding that the term health claim embraced disease treatment claims.172 The NLEA's health claim language, and the legislative intent underlying it, reveal that Congress did not intend to restrict the scope of health claims to instances in which nutrients lowered the risk of, or forestalled, disease but, rather, understood the language to embrace all relationships between nutrients and diseases, including those in which nutrients treat disease. In Whitaker v." - Jonathan W. Emord, The Rise of Tyranny (Get the book.)

"Labeling information is strictly limited by the Dietary Supplement Health and Education Act (DSHEA), which the FDA passed in 1994. dshea created new guidelines for supplement makers about how they could market, package, and label their products—and put strong limits on any claims made about the medicinal use of those products. A supplement label can make "structure and function claims," which describe only the ways in which the nutrients affect the body's structure or function. But it can't state that the supplement prevents or treats any disease." - Hyla Cass, M.D., Supplement Your Prescription: What Your Doctor Doesn't Know About Nutrition (Get the book.) "Labeling information is strictly limited by the Dietary Supplement Health and Education Act (DSHEA), which the FDA passed in 1994. dshea created new guidelines for supplement makers about how they could market package, and label their products—and put strong limits on any claims made about the medicinal use of those products. A supplement label can make "structure and function claims," which describe only the ways in which the nutrients affect the body's structure or function. But it can't state that the supplement prevents or treats any disease." - Hyla Cass, Supplement Your Prescription: What Your Doctor Doesn't Know About Nutrition (Get the book.)

"This move would defeat the dshea and would create an effective cordon sanitaire (protective zone) around the pharmaceutical industry's monopoly on therapeutic claims. Ordinarily shy about revealing any direct involvement in affecting supplement claim decisions at the agency (to preserve the false impression that FDA's drug center does not lord over the food center), at least one industry player has seen fit to demand a reclassification of claims in an overt manner, relying on Whitaker III for support." - Jonathan W. Emord, The Rise of Tyranny (Get the book.)

"While dshea did not allow supplement labels to claim that products prevent, cure, or treat disease, it expressly allowed them to be marketed with "structure/function" claims —claims that the product supports some body structure or function—that appear almost the same as FDA-approved health claims. Although supplement labels are forbidden to say that the product prevents heart disease, they are allowed to say that it "promotes heart health." The labels cannot say that the product prevents colds or AIDS, but they can say that it "supports a healthy immune system." - Marion Nestle, What to Eat (Get the book.) "In 2005, a federal judge in Utah (where Senator Orrin Hatch, the architect of dshea, is the principal protector of the interests of that state's supplement companies) ruled that ephedra could be sold there because the FDA had failed to prove that low doses caused harm. Nevertheless, the national ban was a wake-up call, and some supplement makers now think that a stronger FDA would be a good thing, mainly to counter the "myth" that the FDA has lost control over supplements." - Marion Nestle, What to Eat (Get the book.)

"When the dshea was passed, the U.S. Food and Drug Administration (FDA) estimated that there were about four thousand dietary supplements on the market. After this law was passed, the number has increased dramatically to more than thirty thousand, with more than one thousand being added each year. It is difficult to estimate the market for herbal products, but the best estimates place the annual sales for 2005 in the United States around $5 billion. The global market for botanical medicines stands at more than $60 billion annually (World Health Organization, 2003) and is growing steadily." - David Winston, RH(AHG), and Steven Maimes, Adaptogens: Herbs for Strength, Stamina, and Stress Relief (Get the book.)

"In-stead, it makes the FDA responsible A"* ongress passed dshea in 1994 on the for proving supplements harmful ?in basis of two quite questionable court (on the basis of evidence from assumptions: that supplements are clinical trials or reports of harm to basically harmless, and that supplement many individuals)—before doing any- makers are honest, thing about them." - Marion Nestle, What to Eat (Get the book.)

"First parties who profit from the product's sales must adhere to strictly narrow structure-and-function claims allowed within the dshea framework. However, third parties like The Doctors' Prescription for Healthy Living, that is, publishing companies and other sources of information that do not profit from the sale of the product, are protected under the First Amendment and may make stronger claims. But these claims and reports should still be balanced and objective." - David Steinman, Safe Trip to Eden: Ten Steps to Save Planet Earth from the Global Warming Meltdown (Get the book.)

"In fact, the FDA battled vigorously against the dshea Act in 1994 that finally allowed nutritional supplement manufacturers to make qualified statements on their products, as long as such statements were followed with the quote, "This statement has not been endorsed by the FDA." We should allow supplement manufacturers to tell the truth about what their products do when it is based on available clinical evidence. It shouldn't be illegal to speak the truth about the relationship between nutrition and chronic disease." - Mike Adams, The Seven Laws of Nutrition (Get the book.)

"More reading on health freedom The Growing Threats to dshea www4.DR-Rath-Foundation.org/us/index.html Would You Buy A Used Car From This Man? By Scott Tips www.TheNHF.com/codex_66.htm Chapter 5: Natural Health Solutions "Vitamins and other effective natural health therapies that optimize cellular metabolism threaten the pharmaceutical "business with disease" because they target the cellular cause of today's most common diseases—and these natural substances cannot be patented." - Matthias Rath, MD. Welcome to the solutions section of this book." - Mike Adams, Natural Health Solutions (Get the book.)

"Under the dshea, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Just like drugs, the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers neither need to register their products with the FDA, nor are they required to get FDA approval before producing or selling a dietary supplement unless it contains a new dietary ingredient not marketed or present in the food supply before October 15, 1994." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"The purpose of dshea was to be able to market the benefits of supplements, whether or not backed up by science. Supplements brought in more than $60 billion in worldwide sales in 2004, of which nearly $21 billion was spent in the United States alone. The U.S. figure represents a doubling since 1994. But the rate of growth ?the figure that Wall Street cares about—has declined almost steadily from a peak of 14 percent in 1997 to just under 4 percent in 2002." - Marion Nestle, What to Eat (Get the book.)

"Each year several Democratic members of Congress take it upon themselves to attack dshea, always under the false excuse of protecting the public from harm. In the House, the attack is led by Susan Davis (D-CA). Her current bill is H.R. 3156: Dietary Supplement Access & Awareness Act. It is similar to other efforts she has made in recent years. It is an attempt to regulate supplements and allow the FDA to remove them from the market upon the slightest suspicion of risk. The usual co-sponsors are Henry Waxman (D-CA) and John Dingell (D-MI)." - Byron J. Richards, Fight for Your Health: Exposing the FDA's Betrayal of America (Get the book.) "Ridiculous attacks on dshea need to stop. Codex must be stopped. Americans Must Join Together Today, communication is easier than ever before. The internet allows for news to spread rapidly and for people to connect. It is a new community, which still needs grounding in strong local communities. We must continue to have internet freedom, with equal access for all. The freedom fighters in America now have battles on multiple fronts." - Byron J. Richards, Fight for Your Health: Exposing the FDA's Betrayal of America (Get the book.) "The Senate also attacks dshea through Richard Durbin (D-IL). An early version of his attack was S 722: Dietary Supplement Safety Act of 2003. Co-sponsors were Hillary Clinton (D-NY), Charles Schumer (D-NY), and Dianne Feinstein (D-CA). This bill never passed. In June of 2004, Durbin tried to sneak the bill through as an amendment to a defense-spending bill, an action that was headed off by consumer protest. However, former supporter of the supplement industry Senator Orin Hatch (R-UT) made a compromise with Durbin." - Byron J. Richards, Fight for Your Health: Exposing the FDA's Betrayal of America (Get the book.) "We need to stand up for the rights provided by dshea and our First Amendment. Americans need to support any true health-freedom legislation, as a top priority. Right now this is reflected by Ron Paul's (R-TX) H.R. 4282, the Health Freedom Protection Act. Americans are in a difficult situation. The leaders of both parties are bought off by Big Pharma. Big Pharma is inextricably linked to oil companies, war companies, multinational agribusiness, new biotechnology, and the international banking system. Thus, health freedom is an issue of undeniable importance for all Americans." - Byron J. Richards, Fight for Your Health: Exposing the FDA's Betrayal of America (Get the book.)

"The dshea Structure-Function Claim section refers to the claim made on the U.S. label, as authorized by Section 6 of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under this law, manufacturers are authorized to make "statements of nutritional support" regarding dietary supplement products, including how a supplement can affect the structure or function of the human body. Such claims are not required to be pre-approved by the Food and Drug Administration (FDA)." - Mark Blumenthal, The ABC Clinical Guide to Herbs (Get the book.)

"Under the dshea regulations, manufacturing companies may also indicate to customers possible areas of concern such as potential side-effects and contraindications.6 Manufacturers are required to ensure that they can substantiate any claim made and that any statements made about their products are truthful and not misleading, but they are not required to seek pre-approval from the FDA. In all cases where the claims have not been approved by the FDA, the following disclaimer must be placed on the label: "This statement has not been evaluated by the Food and Drug Administration." - Heather Boon, BScPhm, PhD and Michael Smith, BPharm, MRPharmS, ND, The Natural Medicine Guide to the 50 Most Common Medicinal Herbs (Get the book.)

"FDA Issues Final Rules for Structure/Function Claims for Dietary Supplements Under dshea. HerbalGram 2000;48:32-8. Braun H, Frohne D (1987) Heilpflanzenlexikon fur Arzte und Apotheker, 5th edition. Fischer Verlag, Stuttgart. Braun R, Surmann R, Wendt R, Wichtl M, Ziegenmeyer J (eds.). Standardzulassungen fur Fertig-arzneimittel: Text und Kommentar, 11. Erganzungslieferung. Stuttgart, Germany: Deutscher Apotheker Verlag. February 199611499.99.99. Brinckmann et al." - volker schulz and Rudolf Hansel, Rational Phytotherapy: A Reference Guide for Physicians and Pharmacists (Get the book.)

"This has led critics of dshea to fear a potential "safety meltdown." Despite legitimate concerns about herb safety, the general lack of epidemiological evidence to the contrary suggests such a meltdown has not occurred since the passage of dshea, probably as a result of a combination of factors." - Mark Blumenthal, The ABC Clinical Guide to Herbs (Get the book.) "FDA, there are numerous provisions in the FDCA and dshea that give the FDA adequate authority to remove unsafe supplements from the market: "...it appears that the FDA has substantial and sufficient regulatory authority to protect the American public from any dangerous or otherwise unsafe herbs or other dietary supplement products despite statements to the contrary from FDA officials." (McNamara, 1996). DSHEA also required the establishment of an Office of Dietary Supplements (ODS) within the National Institutes of Health (NIH) and a Commission on Dietary Supplement Labels." - Mark Blumenthal, The ABC Clinical Guide to Herbs (Get the book.)

"Some Fine Distinctions In passing dshea, Congress let stand a distinction it had made in 1990 between a disease claim that would render a supplement a drug and a health claim—-by definition, a statement preauthorized by the FDA about the relationship between a dietary factor and a medical condition or risk factor. dshea specified, however, that the FDA was not to demand scientific proof of statements of nutritional support (structure/function statements) as long as they were "truthful and not misleading" and did not use such words as diagnose, treat, prevent, cure, or mitigate." - Marion Nestle, Food Politics (Get the book.)

"In passing dshea, Congress noted in the "findings" section of the Act that "consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements." One of the purposes of passing dshea, therefore, was to provide consumer access to products and truthful information about those products, while maintaining authority for the FDA to take action against products that present safety problems or are improperly labeled (Soller, 2000)." - Mark Blumenthal, The ABC Clinical Guide to Herbs (Get the book.)

"Annette Dickinson, the vice president for scientific and regulatory affairs at the supplement trade association, the Council for Responsible Nutrition (CRN), testified to this effect before a congressional committee in March 1999: "DSHEA is working. It could work even better if FDA has sufficient resources to complete some of its remaining obligations under dshea. . . . FDA does not have adequate staff or other resources to properly evaluate the adverse event reports. . . . This puts every company at risk of being held 'guilty until proven innocent' without investigation." - Marion Nestle, Food Politics (Get the book.) "SUPPLEMENT INDUSTRY WINS DSHEA; FDA COMPROMISES These arguments continued into the next year, until Congress passed dshea and the President signed it into law on October 25,1994. Industry officials hailed the bill as a "move forward for the 100 million consumers who rely on dietary supplements . . . and the millions more who could benefit from these products. . . . [We were] happy we were able to get the bill through Congress this year. . . . We achieved most of our legislative goals." - Marion Nestle, Food Politics (Get the book.)

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