Academic journal article Journal of Law and Health

Misconceptions and Misleading Information Prevail - Less Regulation Does Not Mean Less Danger to Consumers: Dangerous Herbal Weight Loss Products

Academic journal article Journal of Law and Health

Misconceptions and Misleading Information Prevail - Less Regulation Does Not Mean Less Danger to Consumers: Dangerous Herbal Weight Loss Products

Article excerpt

I. 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. …

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