The history of natural drugs in the United States is as follows. In the early 1900s congress was attempting to regulate health fraud with two different bills. The Food, Drug and Cosmetic Act that would, “enhance the enforcement authority of the Food and Drug Administration, and for other purposes” [1]. Judicial recall is defined in section 2 as, “Any district court of the United States may order the appropriate person (including the manufacturer...) to recall a food, drug, device, or cosmetic which is in violation of this Act if the violation involves fraud or presents a significant risk to human or animal health.” The bill then goes on to elaborate on administrative recall authority, subpoena authority, and civil money penalties. Administrative recall authority gives the Secretary the right to recall a drug if it is in violation of the Food, Drug and Cosmetic Act (Sec 3). Subpoena authority give the authority for the Commissioner to require documentation, “the Commissioner may issue subpoenas requiring the attendance and testimony of witnesses and the production of documentary evidence” (Sec. 5).
The civil money penalties apply to those that: provide false evidence, fail to disclose a material fact which they had a known obligation to disclose, bribery, destroy evidence, or obstruct an investigation of the department. Those that violate the act by doing any of the preceding “shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty of not more than $250,000 in the case of an individual, and $1,000,000, in the case of any other person, for each such act” (Sec 6). In basics this bill was made in hopes to regulate natural and alternative medicines by the FDA and give them the power to make those that were in violation of the regulation pay for the crime. The act accompanying the Food, Drug, and Cosmetic Act would be, “ the Federal Trade Commission Act to make it illegal to advertise nutritional or therapeutic claims that would not be permissible on supplement labels” (Barrett 1). When the health-food industries heard of this act they rallied their troops together to oppose it, claiming that it would put retailers out of business and that the government was trying to take away our right to purchase vitamins. They urged Congress to “preserve the consumer's freedom to choose dietary supplements. What this effectively caused was the act DSHEA.
The DSHEA:
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994
PUBLIC LAW 103-417
- would actually contradict the executive order, if it were to ban such drugs in cahoots with the pharmaceutical company. This act laws down the law that
- (1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;
- (2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;
- (3)(A) there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and
- (B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;
- Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
The problem with this it that , “when a supplement is marketed it’s more or less the honor system. No registration with the FDA is required.”(Gorski 2)
“DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements” (Barrett 2).
The DSHEA went even further and created the “NIH Office of Dietary Supplements and directed the President to appoint a Commission on Dietary Supplement Labels to recommend ways to implement the act” (Barrett 1).
The passage of this act made it to where industries can use false advertising, as we have seen by vitamin commercials that claim you will lose weight or lead a healthy life if you pop this pill everyday. “What goes through your mind when you see an ad which suggests that a pill can help you lose weight permanently without dieting or exercising? If it doesn't strike you as phony, you don't know the facts. There is no such pill” (Mirkin). Advertisers can also get around the act by not advertising their product by not having unsubstantiated drug claims on the label and instead informs the public by, “promoting the ingredients of the products through books, magazines, newsletters, booklets, lectures, radio and television broadcasts, oral claims made by retailers, and the Internet” (Barrett 2).
DSHEA also stops the FDA from banning suspecting supplemental ingredients as "unapproved food additives." This was the most efficient strategy for the FDA before this bill passed due to the avoidance of taking action against individual manufacturers. Because of this passing the FDA has to find ways to prove that the drugs can be unsafe, and since the manufacturers do not have to submit safety information before marketing” dietary supplements, the FDA must fall on using”
Now the only way to banish an ingredient is to prove it is unsafe. Ingredients that are useless but harmless are protected. Nor is there any practical way for the FDA to ensure that the ingredients listed on product labels are actually in the products.
Because manufacturers are not required to submit safety information before marketing "dietary supplements," the FDA must rely on adverse event reports, product sampling, information in the scientific literature, and other sources of evidence of danger. Since the FDA is unable to monitor and regulate thousands of individual products, the public is virtually unprotected against supplements and herbs that are unsafe. In recent testimony, FDA Commissioner Jane E. Henney, M.D., even pointed out:
Products that contain substances similar to those found in prescription drugs are marketed for children as dietary supplements. Likewise, products with ingredients that simulate illicit street drugs are marketed as dietary supplements to adolescents via the Internet and shops specializing in drug paraphernalia."
Another problem with the Dietary Supplement Act is that it does not restrict dietary supplements before they are marketed. The government can not restrict these drugs until they pose "significant and unreasonable risk". This makes it to where the FDA can restrict drugs after they have already caused harm to the public. Examples of when this causes problems are in a few examples: “The association of A. fangchi with urothelial carcinoma is not the first instance in which dietary supplements have caused potentially serious harm, although this is the strongest association of an herb with a cancer in humans. Among the other well-documented examples of adverse reactions are the association of germander with acute hepatitis, of comfrey with hepatic veno-occlusive disease, of yohimbe with seizures and renal failure, and of ephedra with death from cardiovascular causes” (Nortier). It seems as though it takes drastic acts to happen for the drug administration to put any regulations on these alternative drug companies. In 1962 an amendment to the Federal Food, Drug and Cosmetic Act. This amendment to the Thalidomide tragedy where thousands of children were born with birth defects as a result of mothers taking thalidomide to stop morning sickness. This amendment “ required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications” (wikipedia).
After this act carried out the drug companies finding ways to avoid getting their drugs passed by the FDA and causing more difficulty in making them viable claims about their drugs the FDA tried to pass new rules in 1998 as require by DSHEA.
These rules included:
- Disease claims are not permitted.
- Disease is defined as "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof of the body that is manifested by a characteristic set of one or more signs or symptoms."
- "Signs or symptoms" include laboratory or clinical assessments that are characteristic of a disease, such as an elevated cholesterol fraction, uric acid, or blood sugar, and characteristic signs of disease, such as elevated blood pressure
- A claim that a product helps protect against a disease (e.g., "reduces the stiffness of arthritis") is a disease claim.
- A product name that implies an effect on a disease, e.g. "Hepatocure" would constitute a disease claim, but names such as "Cardiohealth" or "Heart Tabs" would not.
- Suggestions that a product helps fight a specific disease or type of disease by stimulating the body's defenses would be disease claims, but "general claims such as "supports the immune system" would no
On January 6, 2000 the FDA was forced into the submission of making a revised final rule due to thousands of protests from the supplemental industry and its allies (Barrett 4). The final rule states that “ Without prior FDA review, products may not bear a claim that they can prevent, treat, cure, mitigate or diagnose disease” (Barrett 4). The final rule was able to prohibit express disease claims, and implied disease claims.The rule permits health-maintenance claims ; other non-disease claims and claims for common, minor symptoms associated with pregnancy, menopause, or other life stages” (4).
In 2006 an occurence towards having more regulation finally came into effect known as the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546). This act required that “manufacturers must report deaths; life-threatening experiences; inpatient hospitalizations; persistent or significant disability or incapacity; birth defects; or the need for medical intervention to prevent any such problems. Manufacturers will also have to place a telephone number or address on product labels so consumers can contact them.” as of December 2007.
A survery taken by the Public Policy institute performed a random digital dial survey on people 50 years of age and older between September 7 and 9, 2001 by Rosper ASW, Princeton, MJ where the “respondents were asked an array of questions related to their use of dietary supplements as well as their understanding of, and priorities for, government regulation of these porducts” (Data Digest 2). This survey shows how much people know about the drugs they are taking at the ages of 50 and above. The results were shocking with 78 percent of the surveyed “were supplemental users that they take these products to promote overall good health, while 52 percent said they take them to provide nutrients missing in their diets. More than one in four supplement useres (27 percent) said they take supplements because their doctor or health care provider recommended them.” The problem is the proceeding paragraph, “Only 41 percent of all respondents (those who do and do not use supplements) said they have discussed taking dietary supplements with their doctor, while more than half (53 percent) siaid they have never discussed this issue with their doctor” (Data Digest 3).
The second to newest government scandal out on the issue is an executive order by Obama. Executive Order 13544 of June 10, 2010. This order faces controversy due to people feeling it will lead to communism. This is not far stretched considering the health care bill that takes away many freedoms, such as the choice for your doctor, what’s in your plan, being rewarded for healthy living,freedom to choose high deductibles and freedom to choose your doctor (Tully). There was also the “issue” that the bill was passed at the time everyone was focused on the oil spill. As a person wrote in the blog REMIXX WORLD! “The federal government is the last entity that should mandate lifestyle behavior considering the number of convicted criminals and deviants who work or have worked for the federal government.” He is making this statement due to section 6 part (c) “contains a list of national priorities on health promotion and disease prevention to address lifestyle behavior modification (emphasis added) (including smoking cessation, proper nutrition, appropriate exercise, mental health, behavioral health, substance-use disorder, and domestic violence screenings) and the prevention measures for the five leading disease killers in the United States;” Yet if you read above, the actual terms of section 6. It is stating that reports must be given on these issues. “Sec. 6. Reports. Not later than July 1, 2010, and annually thereafter until January 1, 2015, the Council shall submit to the President and the relevant committees of the Congress, a report that” (Executive order13544). In truth though this executive order is just an attempt to start regulating the drugs that have harmed our society and put them through some chain of command that includes Secretaries and Administrators (Executive Order Section 2 Membership).
Another recent bill that’s being opposed is the Dietary Supplement Safety Act of 2010. This act will in fact regulate the drug agencies under section 2 © (a), “ In General- A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce” (DSSA).
Another part of this act this is setting the people into fight mode is, “(2) in subsection (c), by striking ‘was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994’ and inserting ‘is not included on the list of ‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary’” because there is not currently a list out about what these ‘Accepted Dietary Ingredients’ drugs could be banned. The organizations that oppose this bill are the Association of American Physicians and Surgeons, National Products Association, MassLPA, Vitamin-Freedom, The POP Campaign, American Herbal Products Association, Alliance for Natural Health USA, Health Freedom Alliance, National Health Freedom Action, Life Extension, The John Birch Society, Green Pasture, Arizona Homeopathic and Integrative Medical Association and Citizens for Health.
Another part of this act this is setting the people into fight mode is, “(2) in subsection (c), by striking ‘was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994’ and inserting ‘is not included on the list of ‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary’” because there is not currently a list out about what these ‘Accepted Dietary Ingredients’ drugs could be banned. The organizations that oppose this bill are the Association of American Physicians and Surgeons, National Products Association, MassLPA, Vitamin-Freedom, The POP Campaign, American Herbal Products Association, Alliance for Natural Health USA, Health Freedom Alliance, National Health Freedom Action, Life Extension, The John Birch Society, Green Pasture, Arizona Homeopathic and Integrative Medical Association and Citizens for Health.
In conclusion many people seem to oppose any regulations on natural drugs even though they have been proven to cause harm that at times is not even fully known. The times that acts try to pass through the government people strongly oppose them and make claims that they will regulate or ban drugs without even seeming to read the entirety of the bill. There are many alternative medicines out there that do not need to be banned and cause many benefits to society. The problem seems to be that people think these drugs will not cause them harm because they are “natural” even though they cannot know if they are due to the lack of regulation. Through this essay I have learned that the only way to know what a bill is doing is to actually read it yourself.
Data Digest 66 Public Policy Institute. “Dietary Supplements and Older Consumers”. 2001
Executive Order 13544 of June 10, 2010
<http://edocket.access.gpo.gov/2010/pdf/2010-14613.pdf>
Food, Drug, Cosmetic, and Device Enforcement Amendments of 1991 (H.R. 2597, 102nd Congress).
Nortier. New England Journal of Medicine. June 2000
Gabe Mirkin, M.D. Foreword to book: The Vitamin Pushers: How the "Health Food" Industry Is Selling Americans a Bill of Goods
Gorski, David “Herbs & Supplements,Nutrition,Politics and Regulation”. Science Based Medcine. 2010
<http://www.sciencebasedmedicine.org/index.php/the-dietary-supplement-safety-act-of-2010-a-long-overdue-correction/>
Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. Proposed rule. Federal Register 63:23624-23632, 1998
S.3002 - Dietary Supplement Safety Act
<http://www.opencongress.org/bill/111-s3002/text>
Top recipients opposing bill
<http://www.opencongress.org/bill/111-s3002/money>
Tully, Shawn. “5 freedoms you'd lose in health care reform“. CNN Money. 24 July 2009.
Wikipedia, 1962 Kefauver-Harris Amendment
<http://en.wikipedia.org/wiki/Kefauver_Harris_Amendment>
