What’s in Your Medicine Cabinet?

Consumers who choose homeopathic remedies and dietary supplements may not be getting what they expect.

Homeopathic Pharmacy, Photo by Jorge Royan (Wikimedia Commons) Homeopathic Pharmacy, Photo by Jorge Royan (Wikimedia Commons)

Homeopathy is a form of alternative medicine that utilizes natural remedies to treat the whole person. Proponents believe that “likes cure likes,” meaning that a remedy that causes certain symptoms in a healthy person will treat a sick person who exhibits those same symptoms. Homeopaths also rely on the principle of “minimum dose,” whereby substances undergo multiple dilutions in order to obtain the optimal therapeutic result.

Although advocates embrace its natural treatments and individualized approach to treatment, homeopathy is a controversial field of medicine. A 2014 study conducted by Australia’s National Health and Medical Research tested homeopathic remedies on sixty-eight widely varied conditions, including asthma, the common cold, arthritis, and heroin addiction, and found them entirely ineffective for each.

Worse than allegations that remedies contain nothing are reports of homeopathic medicines contaminated with actual prescription drugs.

The Australian study echoes the concerns of the 10:23 Campaign, a non-profit group devoted to stimulating “scientific skepticism” about the field. Disdainful of the “absurd pseudoscience,” the 10:23 Campaign’s slogan states, “Homeopathy: There’s Nothing In It,” a jibe at the minimum dose dilution practices.

Worse than allegations that remedies contain nothing are reports of homeopathic medicines contaminated with actual prescription drugs. On March 20, 2014, the Food and Drug Administration (“FDA”) announced that Terra-Medica, a homeopathic drug company, was voluntarily recalling fifty-six lots of its products after the FDA found that they contained penicillin. Although purportedly derived from the same fungal strain as the penicillin drug, the products were marketed as free of antibiotics. Pleo-Quent, one of the recalled products, was said to be an effective, drug-free remedy for everything from the common cold to chicken pox. In its consumer safety alert, the FDA warned that the products could cause life-threatening anaphylactic reactions in unknowing consumers with penicillin allergies.

Unfortunately, this is not an isolated incident. In 2009, the FDA advised consumers to stop using Zicam, a popular line of homeopathic nasal cold products, after it received more than 130 reports that it caused users to lose their senses of smell. The Agency also issued a warning letter to Zicam’s parent company notifying of serious FDA violations, including misbranding and the illegal introduction of a new drug into interstate commerce. The company subsequently issued a voluntary recall of the products.

Except for those that contain a “new dietary ingredient,” dietary supplements are not subject to any premarket FDA regulation whatsoever.

The dietary supplements industry presents another major, related cause of concern for consumer rights groups and proponents of traditional medicine alike. In abstract terms, the variance between an all-natural homeopathic remedy and a safe vitamin supplement is minor. Practically, however, the distinction is tremendous.

Nearly half of U.S. adults consumed some type of supplement in 2009-2010.

The term “dietary supplement” encompasses a vast array of products, including everything from an over-the-counter daily multivitamin to a bodybuilding product containing dangerous synthetic steroids. According to a March 2013 report (pdf) released by the United States Government Accountability Office, nearly half of U.S. adults consumed some type of supplement in 2009-2010.

Indeed, over the last twenty years, the dietary supplements industry has steadily become a big business, as well as a big problem. The main issue with dietary supplements is that they are not required to undergo any tests for safety or effectiveness prior to their sale. In fact, except for those that contain a “new dietary ingredient,” meaning one not marketed in the United States before Oct. 15, 1994, dietary supplements are not subject to any premarket FDA regulation whatsoever.

The crucial difference between homeopathy and dietary supplements is their legal status under the Federal Food, Drug, & Cosmetic Act (“the Act”). Although homeopathic medicines are certainly subject to more relaxed standards than are their prescription counterparts, they constitute drugs within the meaning of the Act and as such, fall under the FDA’s regulatory authority. Dietary supplements, on the other hand, are foods, according to the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), an amendment to the Act.

Although extremely effective at increasing metabolic rates, Ephedra was linked to multiple adverse events, including seizures, heart attacks, psychosis, strokes, and sudden deaths.

Congress’s decision to classify dietary supplements as foods, rather than the arguably more analogous category of drugs, has led to a market influx of dangerous products. Essentially anyone may manufacture and sell a dietary supplement under DSHEA; doing so requires no FDA approval. Supplement manufacturers are responsible for the safety and effectiveness of their products, but without the FDA’s regulatory authority, there is nobody to check the manufacturers. The FDA may not step in until after health or safety concerns have been reported. By that point, injury has already occurred.

Perhaps the most notorious dietary supplement ingredient in recent years is ephedra. Native to Asia, the herb was commonly used in weight loss supplements in the 1990s. Although extremely effective at increasing metabolic rates, ephedra was linked to multiple adverse events, including seizures, heart attacks, psychosis, strokes, and sudden deaths. In 2003, Baltimore Orioles pitcher Steve Bechler died after collapsing from heatstroke; the toxicology report revealed that ephedra played a “significant role” in his death. The FDA banned dietary supplements containing ephedra in 2004, but supplement manufacturers quickly replaced it with bitter orange, a substitute. The ingredient has been reported to cause side effects similar to those caused by ephedra.

Arguably the most alarming product contamination occurs when supplements are tainted not by prescription drugs, but by other harmful substances.

Given the lack of premarket oversight, it is unsurprising that product contamination is even more rampant within the dietary supplements industry than the homeopathic medicines industry. In January 2014, the FDA found that Dream Body Slimming Capsule contained sibutramine, yet another banned weight loss ingredient. On April 16, the Agency issued a similar consumer warning about S.W.A.G., a sexual enhancement product, after finding that it contained sildenafil, the active ingredient in prescription-only Viagra.

Arguably the most alarming product contamination occurs when supplements are tainted not by prescription drugs, but by other harmful substances. In 2002, 17-year-old Leta Hole died after overdosing on weight-loss pills that she purchased over the Internet. The pills contained DNP, a dangerous pesticide, and the chemical reaction they caused literally burned up her organs from the inside out. In recent years, DNP has been linked to approximately sixty supplement-related deaths worldwide.

Product contamination and a lack of industry oversight are troublesome realities for both the homeopathic and the dietary supplements industries.

Certainly, not all homeopathic medicines and dietary supplements are ineffective or dangerous. But product contamination and a lack of industry oversight are troublesome realities for each of these industries in varying degrees. Consumers are woefully ignorant, and it is to the detriment of the greater public’s health.

Liles Demmink, Former Associate Editor/Ethics
About Liles Demmink, Former Associate Editor/Ethics (12 Articles)
Liles Demmink served as the Associate Editor of Ethics for the Campbell Law Observer during the 2014-2015 school year. She graduated from the University of North Carolina at Chapel Hill in May 2009 with a degree in Journalism and Mass Communication. Post-graduation, Liles moved to Boston, MA, where she worked for a marketing consulting firm until she returned to NC to attend law school. During the summer of 2013, Liles interned with the Honorable Ann Marie Calabria of the North Carolina Court of Appeals. Liles also served as a Legal Research and Writing Scholar at Campbell. She graduated from Campbell Law School in May 2015.
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