Misconceptions and misleading information prevail - less regulation does not mean less danger to consumers: dangerous herbal weight loss products.

• Author: Sardina, Jennifer

1. INTRODUCTION

   "Instead of walking down the aisle before a bride. I walked behind a casket," wept Mary Jo Linnen, mother of a thirty-year-old woman who died in February 1997 of a heart and lung disorder after taking the prescription "drug cocktail," fen-phen to lose a few pounds before her wedding.(1)

   Unfortunately, dieters experienced an array of negative side effects from taking fen-phen before the diet drug pair, a combination of fenfluramine (brand name Pondimin) and phentermine (brand name Redux), was voluntarily removed from the market upon the Food and Drug Administration's (FDA) request.(2) Although the FDA did not approve this simultaneous, off-label use(3) of these two drugs, doctors prescribed the mixture millions of times each year.(4)

   Weight conscious consumers have flocked to various brands of "herbal fen-phen" since the withdrawal of prescription fen-phen.(5) These herbal alternatives do not contain the prescription drugs fenfluramine or phentermine;(6) consequently, consumers can browse the aisles of a health food store and choose from numerous versions of herbal fen-phen type products that all promise the same results.(7) However, the dangerous reality is that these products have not been proven safe and Effective.(8) Legislation currently governing dietary supplements is dangerously inadequate. Specifically, the Dietary Supplement Health and Education Act of 1994 (DSHEA)(9) reaffirms that dietary supplements are to be classified as foods.(l0) This classification does not provide enough protection for consumers in relation to herbal fen-phen products.

   Furthermore under the DSHEA, the FDA cannot even require manufacturers to test herbal products before sold for safety or efficacy,(11) rather individual manufacturers may decide what is necessary to provide "reasonable assurance" of a products' safety.(12) The FDA Secretary, based on limited powers granted by the DSHEA, may remove a dangerous or adulterated supplement only when it poses an "imminent hazard to public health or safety."(13) Such action is simply too little too late in most instances.

   This Note will examine the dangers associated with current dietary supplement regulation under the DSHEA(14) and the problem of ill-informed consumers.(15) As reflected in the title of this Note, misconceptions about dietary supplement regulation are abundant; consequently, section II of this Note will further discuss and offer illustrations in support of this position. Part III gives an overview of current regulation under the Dietary Supplement Health and Education Act of 1994. Also a brief discussion of the legislation that preceded the DSHEA is offered in section VI.

   Part V of this Note analyzes and defines the dietary ingredients that are often found in herbal fen-phen products. Specifically, this section discusses the dangerous and unsubstantiated claims associated with these supplements.

   Part V concludes by contrasting prescription fen-phen with herbal fen-phen to explain the dangers associated with both and the dire need for prompt action to protect consumers from "herbal" substitutes.

   Part VI offers concrete proposals for dealing with inadequate regulations, which this Note maintains are threatening consumers' health. Finally, remedies such as legislative amendment and increased funding for training, research, and consumer awareness efforts will be further explored.

   In the Fall of 1997, the FDA did warn consumers about the dangers related to herbal fen-phen;(16) however, since then nothing concrete has been done to put a stop to the sale of these menacing supplements. The FDA noted that products, which are intended to be used as alternatives to prescription drugs, require FDA approval before being made available to consumers.(17) The FDA stated that herbal fen-phen products are indeed marketed as drug alternatives to prescription anti-obesity drugs.(18) Companies that market or imply weight-loss benefits by imitating prescription drug names are violating federal law and must be stopped. (19)

   Ultimately, products like these run the risk of being classified as new drugs, requiring FDA approval before sale.(20) The FDA, using the powers earlier mentioned that are designated by the DSHEA to its Secretary, should promptly act to change the current availability of such products to avoid catastrophic health problems.(21)

   Because of the leniency fostered by the DSHEA, some available herbal alternatives contain various dietary ingredients that are dangerous and even deadly.(22) Many herbal fen-phen products contain ephedrine (also known as ephedra or ma huang) and St. John's Wort (also known as hypericum perforatum or "herbal Prozac")(23) In addition to a lack of evidence supporting manufacturer's claims, these dietary ingredients combined may also pose a serious health threat to many uninformed or careless consumers.(24)

2. MISCONCEPTIONS ABOUT DIETARY SUPPLEMENT REGULATION

   The $6.5 billion dietary supplement market evidences American's concern with maintaining and improving their overall health.(25) A significant and growing portion of that figure can be attributed to herbal weight-loss products, such as herbal fen-phen products.(26) These herbal weight-loss products have become more popular since drug manufacturers followed the FDA's admonition in 1997 and removed these prescription diet drugs from the market.(27) Although dieters are eager to shed pounds and continue to rely on promises of quick results from herbal diet remedies, the FDA and nutritionists maintain that there is no evidence that these herbal dietary supplements are effective weight-loss aids.(28) Nutritionists "fret that Americans regard herbs as harmless, no matter what the dose."(29)

   Due to a lack of consumer education and/or misleading advertising, many Americans using dietary supplements falsely believe that the FDA, Federal Trade Commission (FTC),(30) or some other governmental agency will be their watchdog, disallowing any harmful supplements or ingredients.(31) This is simply not true. Dietary supplements do not go through the strict screening that drugs must go Through.(32) Prescription and over-the-counter drug manufacturers must conduct studies on safety and effectiveness before the FDA approves a new drug for sale.(33) Dietary supplement manufacturers only need to demonstrate that a product is safe when taken according to the recommended dosage.(34) In fact, the FDA does not have the power to intervene to stop the sale of a supplement unless it poses an unreasonable risk to health or is marketed as a drag.(35)

   The Federal Food, Drug, and Cosmetic Act (FDCA)(36) defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or any other animals" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals."(37) Furthermore, the FDCA, as amended by the DSHEA, regulates supplements as "foods" and not "drugs," specifically prohibiting dietary supplements from making drug claims.(38)

   Moreover, critics warn that supplements are regulated as foods but used as drugs.(39) Companies that market or imply weight-loss benefits by imitating prescription drug names are violating federal law and must be stopped.(40) Products like these may run the risk of being classified as new drugs, requiring FDA approval before sale.(41) The FDA, using the powers designated by the DSHEA to its Secretary, should promptly act to change the current availability of such products to avoid catastrophic health problems.(42)

   Another governmental agency, the FTC, has a regulating hand in the supplement industry and this agency works closely with the FDA and monitoring advertising for supplements.(43) One example of the FTC's exercise of regulatory dominion occurred in 1997 after the FTC launched a consumer education and regulatory campaign, "operation waistline."(44) Because of this campaign, the FTC engaged in settlement agreements with some supplement manufacturers, prohibiting future advertising that lacks appropriate claim substantiation and trustworthy scientific data.(45) The disingenuous claims made in several products' ads included:

   (1)NEW ALL-NATURAL WEIGHT LOSS PRODUCT, NOW ON THE MARKET! If you've heard about the new `Phen/Fen' Diet, and thought about trying it.... Don't! With the ALL NATURAL `Thin-Thin Diet,' you can achieve the same results, without the dangerous side-effect of Drugs! Eat the foods you want, and STILL lose 10-12 pounds per month!;

   (2) Neuro-Thin turns your `hunger switch' off; and

   (3) Neuro-Thin help[s] balance the levels of serotonin and dopamine in your brain. The result? Food cravings and hunger pangs are eliminated ... and ... you'll be on your way to achieving your goal.(46)

   Because these advertisements make claims based on studies that were not performed on humans, they seem insufficient according to the DSHEA's standard that requires "reasonable assurances" of a new product's safety.(47) According to Food Science and Human Nutrition Specialist, Pat Kendall, Ph.D., R.D., at Colorado State University, another alarming truth associated with inadequate regulation is that unrestricted "[f]actors, such as variations in growth, product preparation, and storage length and conditions, affect the quality and potency of a product. In addition, plants are sometimes improperly identified by manufacturers."(48) Consequently, illustrations of the need for regulatory changes are plentiful; a look at FDA records revealed over 2,500 reports of side effects and 79 deaths associated with dietary supplement use.(49)

   Primarily due to a lack of consumer education and reliance upon government for proactive intervention, the FDA is working to regain more power to protect the public's health.(50) On April 29, 1998, the FDA proposed changes to the current regulatory scheme, hoping to better protect the health of Americans.(51) Until these proposals are approved, the FDA...