American Journal of Law & Medicine

Science, politics, and the regulation of dietary supplements: it's time to repeal DSHEA.(The Dietary Supplement Health and Education Act: Regulation at a Crossroads)

Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerine and limburger cheese ... [T]his historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise. (1)

[Individuals have] the right to be treated by a health care practitioner with any medical treatment (including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services) that such individual desires or the legal representative of such individual desires. (2)

The makers of our Constitution undertook to secure conditions favorable to the pursuit of happiness. They recognized the significance of man's spiritual nature, of his feelings and of his intellect. They knew that only a part of the pain, pleasure and satisfactions of life are to be found in material things. They sought to protect Americans in their beliefs, their thoughts, their emotions and their sensations. They conferred, as against the Government, the right to be left alone--the most comprehensive of rights and the right most valued by civilized men. (3)


Conflict between the orthodox medical community and practitioners of alternative therapies has been a recurring motif throughout the history of medicine. It is not surprising that in today's media and Internet society, where medicine has become as much an industry as a healing art, that many people wish to "take charge" of their bodies, through the latest "blockbuster" medications, whether they be alternative medicines or the more traditional type.

Dietary supplements, a major component of complementary and alternative medicine ("CAM"), have become extraordinarily popular in recent years. (4) The Dietary Supplement Health and Education Act ("DSHEA") (5) was enacted with the goal of facilitating the use of dietary supplements by minimizing their regulation. (6) DSHEA raises three major questions concerning policy and politics:

(1) Are there essential differences between pharmaceuticals and supplements? (7)

(2) If so, do these differences justify the radically different approach under which drugs and supplements are regulated today?

(3) To what extent should the government regulate any substance used to treat, ameliorate or prevent disease?

DSHEA has several critical weaknesses, three of which are of critical importance for this article. First, DSHEA classifies compounds as dietary supplements based on their source, rather than their pharmacologic and physiologic properties. (8) This article will argue that DSHEA's definition of supplement is not based on scientific findings or foundations. Second, DSHEA assumes that components of foods cannot cause harm, even when ingested in large amounts, and that therefore supplements should be subject only to regulations dealing with foods rather than with the more stringent regulations applied to drugs. (9) DSHEA also assumes that since herbs and botanicals are "natural," they warrant regulation only to the same extent as food components, regardless of their pharmacologic, physiologic, or pathologic attributes, and irrespective of whether they are foods at all. (10) This article will maintain that both of these assumptions are erroneous. Third, the marketing of dietary supplements must be accompanied by a statement indicating that these substances are not intended to treat disease, (11) but rather to maintain normal bodily function. This article will claim that this is a meaningless distinction to most consumers, who consider that failure of normal bodily function is a form of disease. This article will conclude that these and other deficiencies inherent in DSHEA render current dietary supplement regulations inherently misleading.

This article will analyze the problem of DSHEA from four perspectives. Part II will review the genesis of the Food, Drug, and Cosmetic Act ("FD&C Act") (12) and DSHEA, compare their approaches to regulation, and question whether purported differences between pharmaceuticals and supplements are sufficient to have warranted the development of such radically different laws governing each. This discussion will include a look at the role of statutorily imposed semantic distinctions. The section will conclude that the supposed differences between "drugs" and "supplements" that have been written into DSHEA are ephemeral, and that they should not determine the scope of a state's regulatory power.

Part III will propose that DSHEA ignores biological findings crucial to the distinction between drugs and supplements. This section will focus on the toxic effects resulting from ingestion of vitamins, amino acids, and botanicals that were documented in the medical literature long before DSHEA was enacted. This section will briefly discuss the issue of establishment hubris, a phenomenon that has existed throughout medical history and has arguably been an impediment to the acceptance of what have become some of today's most important medical therapies.

Part IV will examine the role of public health with regard to supplements and drugs. This section will examine contrasting philosophies concerning the role of government in regulating an individual's use of drugs. The focus here will be on the Rutherford case and the Access to Medical Treatment Act. (13) This section will argue that regulation of both drugs and supplements requires a knowledge base adequate to evaluate their pharmacologic and physiologic effects as well as their risks and benefits. Since most consumers lack this knowledge base, a state has an obligation to act in parens patriae to prevent harm to them.

Part V will propose that the burdens to society imposed by DSHEA greatly exceed any real or theoretical benefit accruing to the individual, and that Congress abrogated its duty to the public welfare when it ended any meaningful FDA oversight of dietary supplements. As a result of Congress enacting DSHEA, the FDA is now unable to prevent entry of unsafe or ineffective supplements into the stream of commerce. While conceding that there are significant problems with the FDA's current implementation of the FD&C Act as it pertains to pharmaceuticals, this article stresses that these deficits do not negate the underlying ideals of the FD&C Act: regulation that is impartial, without bias or conflicts of interest, and based on science rather than politics or ideology.



Much of the impetus behind the origins of today's FDA came from the public's reaction to the revelation of the abuses within the food industry. Shocking disclosures of unsanitary conditions in the food processing plants called attention to the need for governmental regulation. Upton Sinclair revealed fraud and abuse in the meat packing industry in the early 1900s in The Jungle. (14) The novel's powerful role in precipitating the passage of the first Food and Drug Act is revealed in the following excerpt:

   With one member trimming beef in a cannery, and another working in 
   a sausage factory, the family had a first-hand knowledge of the 
   great majority of Packingtown swindles. For it was the custom, 
   as they found, whenever meat was so spoiled that it could not be 
   used for anything else, either to can it or else to chop it up 
   into sausage.... 
   Jonas had told them how the meat that was taken out of pickle 
   would often be found sour, and how they would rub it up with 
   soda to take away the smell, and sell it to be eaten on 
   free-lunch counters; also of all the miracles of chemistry 
   which they performed, giving to any sort of meat, fresh or 
   salted, whole or chopped, any color and any flavor 
   and any odor they chose.... And yet, in spite of this, 
   there would be hams found spoiled, some of them with an odor 
   so bad that a man could hardly bear to be in the room 
   with them.... 
   There was never the least attention paid to what was 
   cut up for sausage; there would come all the way back 
   from Europe old sausage that had been rejected, and that 
   was moldy and white--it would be dosed with borax and 
   glycerine, and dumped into the hoppers, and made over 
   again for home consumption. There would be meat that had 
   tumbled out on the floor, in the dirt and sawdust, where 
   the workers had tramped and spit uncounted billions of 
   consumption germs. There would be meat stored in great 
   piles in rooms; and the water from leaky roofs would 
   drip over it, and thousands of rats would race about 
   on it. It was too dark in these storage places to see 
   well, but a man could run his hand over these piles of 
   meat and sweep off handfuls of the dried dung of 
   rats. These rats were nuisances, and the packers would 
   put poisoned bread out for them; they would die, and 
   then rats, bread, and meat would go into the hoppers 
   together. This is no fairy story and no joke.... (15) 

Congress reacted to these disclosures by passing the original Pure Food and Drug Act in 1906. (16) This Act, the progenitor of today's FD&C Act, prohibited interstate commerce in misbranded and adulterated food, drinks, and drugs and required accurate listing of contents (including narcotics and cannabis) on labels of patent medicines shipped in interstate commerce. (17) The subsequent evolution of food and drug legislation clearly illustrates what can be termed "government by crisis." (18) It took the elixir of sulfanilamide tragedy, which killed 107 people, mostly children, to bring about passage of the Food, Drug, and Cosmetic Act of 1938. (19) This act required that drugs be shown as safe prior to marketing. (20) It was not until 1962, after the thalidomide disaster, that the Kefauver-Harris Amendment mandated that drugs be demonstrated effective as well as safe before they could enter interstate commerce. (21) These and other changes in the scope of the FD&C Act were made in the belief that only strong governmental action could protect individuals from harm that they had no way of combating on their own. (22)


In the early 1990s, Congress was considering two bills that would have increased significantly the federal government's ability to act against health fraud. One proposal would have strengthened the FDA's enforcement powers and increased penalties for violating the FD&C Act. (23) The other would have imposed tight controls on the marketing of nutritional supplements by forbidding manufacturers to advertise therapeutic claims that, by law, could not be placed on the supplement's label. (24) The health-food industry responded with an intense lobbying campaign:

   Alarmed by these developments, the health-food industry 
   and its allies urged Congress to "preserve the consumer's 
   freedom to choose dietary supplements." To whip up their 
   troops, industry leaders warned retailers that they would 
   be put out of business. Consumers were told that unless 
   they took action, the FDA would take away their right to 
   buy vitamins. These claims, although bogus, generated an 
   avalanche of communications to Congress. The end result 
   was passage of DSHEA, which defined "dietary supplements" 
   as a separate regulatory category and liberalized what 
   information could be distributed by their sellers ... 
   [DSHEA] also expanded the types of products that could be 
   marketed as "supplements." (25) 

Although logic should have dictated that "dietary supplements" would only supply essential nutrients missing from the diet, DSHEA's expansive definition encompassed herbs, botanicals, amino acids and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. (26) DSHEA made it possible to reclassify all these substances as "food." Dr. David Kessler, the former FDA Commissioner, protested: "This is not about health and this is not about well-being; this is about money and jumping on a bandwagon." (27)

The Dietary Supplement Health and Education Act was signed into law in October 1994. (28) Its findings, (29) many unsupported by significant scientific data, noted that millions of consumers believed dietary supplements provided health benefits. The Act proclaimed Congress's intent to strike a balance between consumer access to dietary supplements and the FDA's authority to act against supplements that present safety problems or bear false or misleading labeling. (30) In contrast to the FD&C Act and relevant amendments that had imposed strict regulation on the marketing of unsafe and ineffective medications, DSHEA gutted much of what had been accepted as integral to the states' protection of consumers. (31) In moving from strong regulation to a far more permissive approach, DSHEA represented a paradigm shift in the regulatory framework imposed by the federal government on a large number of potent compounds, including substances that had every attribute of pharmaceuticals but were transformed by statute into quite another entity.


The FD&C Act and DSHEA present conflicting provisions in several important areas: (1) the definition of drug and supplement; (2) the evidence required for approval; (3) the burden of proof on which regulation is based; (4) the claims allowed when marketing drugs and supplements.

1. The Definition of "Drug" and "Supplement"

A drug or pharmaceutical is defined in the FD&C Act by what it is intended to do. The Act states:

   The term "drug" means articles intended for use in 
   the diagnosis, cure, mitigation, treatment, or 
   prevention of disease in man or other animals; 
   and articles (other than food) intended to affect 
   the structure or any function of the body of man 
   or any other animals. (32) 

In contrast, dietary supplements, which comprise a wide variety of compounds, some of them only marginally related to "foods" or "diet," are defined in DSHEA by what they are; the uses to which they may be put are almost incidental. DSHEA states:

The term "dietary supplement"--

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2) means a product that

(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or

(ii) complies with section 411(c)(1)(B)(ii);

(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and

(C) is labeled as a dietary supplement ...

Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act. (33)

In spite of these statutory differences, the average purchaser of either a drug or a supplement believes that their purpose is to maintain health and, when appropriate, to treat abnormalities. (34) That one group is sold with the intent to do so, and the other with a disclaimer of such intent is a meaningless distinction imposed by law rather than science or logic, and therefore should be changed.

2. Evidence Required for Approval of Drugs and Supplements

Another major statutory difference between drugs and supplements deals with the evidence required before either substance may enter the steam of interstate commerce. (35) Pharmaceuticals are subject to stringent premarket approval. According to the FD&C Act: "No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application ... is effective with respect to such drug." (36)

In order to secure approval for a new drug's labeling and advertising, "substantial evidence" of safety and efficacy must be demonstrated through accurate and meticulous clinical research. The Act defines "substantial evidence" as:

   evidence consisting of adequate and well-controlled 
   investigations, including clinical investigations, 
   by experts qualified by scientific training and 
   experience to evaluate the effectiveness of the drug 
   involved, on the basis of which it could fairly and 
   responsibly be concluded by such experts that the 
   drug will have the effect it purports or is 
   represented to have ... (37) 

An article may be misbranded "because the labeling or advertising is misleading." (38) A manufacturer can advertise or otherwise promote medications only for indications approved by the FDA. (39) Furthermore, all advertising must be based on data that were approved by the FDA for inclusion in the labeling of the drug. (40) Thus, the Act requires both proven safety and efficacy and accurate labeling and advertising of a drug. (41)

In contrast, DSHEA allows dietary supplements to enter the market without requiring manufacturers to submit safety and efficacy data to the FDA (i.e., without premarket approval). (42) Therefore, dietary supplements may be advertised and sold without any evidence that they are safe and effective. The FDA may take action only after a supplement has been marketed and then been shown to constitute an imminent threat to the public welfare. (43) However, while manufacturers of drugs must inform the FDA when it learns of any adverse response to its products, DSHEA imposes no such mandate and relieves manufacturers of this obligation. (44)

An equally important distinction between drugs and supplements is that manufacturers of supplements may not claim that their products diagnose, cure, mitigate, or treat disease. (45) Although DSHEA mandates that a supplement's label must contain both a disclaimer of intent to treat disease and lack of FDA approval for such purpose, it is likely that many customers will not truly assimilate this information and will use supplements to treat disease. (46) The fact that no biological, physiological, or pharmacologic differences exist between many pharmaceuticals and dietary supplements is totally ignored by DSHEA. The harms that result from this defect are discussed in Part IID.

3. The Burden of Proof on Which Regulation is Based

The FD&C Act's requirement for premarket approval places the burden clearly on the manufacturer. (47) Pharmaceuticals may not enter interstate commerce (except for research conducted pursuant to the FDA's approval process) until substantial evidence of safety and efficacy provided by the manufacturer has been found to be satisfactory by the FDA. (48) In contrast, DSHEA is unambiguous in placing the burden of proof on the government. (49) Supplements may be removed from the market only when the State proves they constitute an imminent hazard threatening the public's health. (50)

   The 1994 Dietary Supplement Act does not require that 
   dietary supplements (defined broadly to include many 
   substances, such as herbs and amino acids, that have 
   no nutritive value) be shown to be safe or effective 
   before they are marketed. The FDA does not scrutinize 
   a dietary supplement before it enters the marketplace. 
   The agency is permitted to restrict a substance [only] 
   if it poses a "significant and unreasonable risk" 
   under the conditions of use on the label or as commonly 
   consumed. (51) 

Since dietary supplements and drugs can both exert significant physiologic and pharmacologic effects, it seems neither rational nor in the public interest to require strikingly different standards of evidence before either can be marketed. The significance of DSHEA's failure to impose the burden of proof on the manufacturer has been noted by the Editor-in-Chief of the Journal of the American Medical Association:

   Under the act's provisions, manufacturers of dietary 
   supplements, unlike manufacturers of pharmaceuticals, 
   are not required to provide evidence of safety or 
   efficacy prior to marketing. Also, except for supplements 
   that contain "a new dietary ingredient," dietary supplements 
   are not required to have FDA approval or even be 
   registered with the FDA before they are produced and 
   marketed. Once a dietary supplement is marketed, the onus 
   is on the FDA to demonstrate that the product is unsafe 
   before it can take regulatory action . … 

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