MD, PhD, FMedSci, FSB, FRCP, FRCPEd

DSHEA

Guest post by Louise Lubetkin

A while ago this sardonic little vignette, titled Medicine Through the Ages, was doing the rounds on the Internet:

2000 B.C. – Here, eat this root.
1000 A.D. – That root is pagan. Here, say this prayer.
1750 A.D. – That prayer is superstition. Here, drink this potion.
1900 A.D. – That potion is snake oil. Here, swallow this pill.
1985 A.D. – That pill is ineffective. Here, take this antibiotic.
2000 A.D. – That antibiotic is unnatural. Here, eat this root.

We seem to have come full circle. The idea of health as a personal goal, something that can be achieved by taking nutritional supplements such as herbal preparations, vitamins and minerals, is a fundamental tenet of alternative medicine. Consequently the rise of alternative medicine has been accompanied by a parallel rise in the use of dietary supplements.

Most people assume that dietary supplements, like pharmaceuticals, are thoroughly tested before being allowed onto the market, and that in any case because they are “natural” they are ipso facto safe.

Neither assumption is correct.

First of all, it is a great mistake to assume that all “natural” substances are harmless and therefore fit for consumption. (Fugu anyone? Perhaps with some sautéed Amanita mushrooms?) Secondly, unlike pharmaceuticals, which must undergo protracted pre-market testing for safety and efficacy, dietary supplements need not undergo even rudimentary testing before being sold over the counter to the public.

Supplement usage is at an all-time high. Currently, almost 50 percent of us regularly take supplements. The older you are, the more likely you are to take them: usage climbs to 70 percent amongst people 70 years and older. Similarly, the more formal education you have had, and the higher your income level, the more likely you are to be a regular consumer of dietary supplements.

Our collective enthusiasm for taking supplements has undoubtedly done considerably more for the health of the supplement industry than it has for that of the public. There is mounting research evidence to suggest that taking dietary supplements may neither be as safe nor beneficial to health as has previously been assumed (more on this in another post). Nevertheless, physicians seem to be just as vulnerable as the rest of us to the blandishments of the supplement industry. According to one study published in the Journal of Nutrition, 75 percent of dermatologists, 73 percent of orthopedists and 57 percent of cardiologists reported personally using dietary supplements. An earlier study by the same research group found that a staggering 79 percent of physicians and 82 percent of nurses reported recommending dietary supplements to their patients. Of course the fact that supplements come with a personal recommendation by a physician only serves to reinforce the public’s ill-founded presumption of safety.

The manufacture and sale of supplements is a hugely profitable business, generating more than $25 billion in annual sales and contributing an estimated $60 billion to the US economy. While most other industries have languished during the current economic downturn, the supplement industry has grown steadily:  overall, between 2008 and 2012, sales of supplements rose by 31.7 percent.

(Ironically, the huge popularity of these so-called “natural” health products has not escaped the notice of agribusiness and pharmaceutical giants such as Kellogg’s, Pfizer, Monsanto and others, all of which have now begun manufacturing and marketing nutritional supplements of their own.)

None of this would have been possible had it not been for the 1994 enactment by the US Congress of the Dietary Supplement Health and Education Act (DSHEA), an extraordinarily ill-conceived piece of legislation that drastically weakened the FDA’s regulatory control over vitamins, minerals, herbal, botanical and other “traditional” medical products. Prior to DSHEA, these products were classified as drugs and were therefore subject to FDA regulation. By reclassifying them as foods rather than drugs DSHEA effectively removed dietary supplements from FDA regulatory oversight. As a result, supplement manufacturers became exempt from any obligation to perform pre-market testing for purity, safety or effectiveness, and it became infinitely harder for the FDA to detect unsafe products and quickly remove them from the market.

While the FDA does have the authority to insist that manufacturers refrain from making unsubstantiated health claims, it no longer has the power to mandate removal of unsafe products from the market without first clearing the almost insurmountable legal hurdle of proving significant risk. In other words, DSHEA inverts the responsibility for ensuring safety. Before the FDA can act, consumers must first be harmed sufficiently seriously, and in sufficient numbers, to trigger an investigation.

In one fell legislative swoop, DSHEA dished up a profit bonanza to the supplement industry while simultaneously robbing the public of any meaningful protection. Thus disencumbered of all but token regulation, the dietary supplement industry quickly burgeoned. In 1994, when DSHEA was enacted, there were just 4,000 dietary supplements on the market. Today there are more than 75,000.

The brave new world spawned by DSHEA is well exemplified by the ephedra case. Herbal weight loss supplements containing the plant alkaloids ephedra and ephedrine were linked to a string of over 150 deaths and countless other serious adverse events. Metabolife, the manufacturer of the supplement, received 15,000 complaints of adverse events – including deaths – related to the product, yet was under no obligation to alert the FDA, and (not surprisingly) chose not to do so.

It took a full 10 years of intense legal fighting for the FDA to succeed in getting ephedra-containing supplements removed from the market. Undeterred, powerful industry lobbying groups and vociferous opponents of regulation mounted a successful appeal challenging the legality of the FDA ban, and ephedra supplements once again went on sale in several states. The ruling against FDA was eventually overturned on appeal and the ephedra ban was upheld, but the cost, difficulty and duration of the legal process of restricting access to this dangerous “natural” supplement was staggering. Yet even now, despite the FDA’s hard-won ban on ephedra, it is perfectly legal to buy ephedrine hydrochloride – an extract of ephedra – over the counter in the US, where it is marketed for sale without prescription as a bronchodilator and nasal decongestant. The only restriction on its sale is that it must be presented in pill form with dosage not exceeding 8mg, and the label cannot promote it as a weight loss aid – a restriction which can be sidestepped with the greatest of ease, as this website, with the in-your-face domain name ephedrinediet.org, vividly demonstrates.

Perhaps not surprisingly, the ephedra case is the only time the FDA has attempted to force the removal of a dangerous supplement from the market. Hamstrung by DSHEA, the FDA can do little more than exert its limited authority over the wording on supplement labels to ensure that manufacturers make no explicit claims that their products may be used prevent, cure or treat a specific disease. However, the lack of seriousness with which an increasingly confident supplement industry takes the FDA and its semantic policing powers is well illustrated by the following statement which appears in a recent report published by the Natural Products Foundation, an industry umbrella and lobbying group:

Healthy consumers use supplements to decrease their risk of heart disease, boost their immune systems, prevent vision loss, build strong bones, or prevent birth defects. Less healthy or ill consumers turn to supplements as an alternative to traditional medical treatments, to either complement prescription drugs they may be taking or substitute supplements for prescription drugs they either cannot afford or do not trust.

There are encouraging signs that concern about the dangers posed by an largely unregulated supplement industry may at last be growing, although industry and grass-roots opposition to attempts to repeal DSHEA have been well organized, well funded and vociferous. Even so, in 2007, largely as a result of public unease over the FDA’s protracted struggle to ban ephedra, DSHEA was amended to make reporting of serious adverse events such as death, life-threatening emergencies, inpatient hospitalizations or significant, persistent incapacities, mandatory. As a result of this amendment, in the first 9 months of 2008 alone, the FDA received almost 600 reports of serious adverse events arising from the use of dietary supplements. Moreover, the FDA believes that adverse events are being seriously under-reported, and that the annual number of supplement-related adverse events in the US is close to 50,000.

Perhaps it will take another ephedra disaster to make us rethink DSHEA, take the handcuffs off the FDA and begin looking more critically at the notion that dietary supplements are intrinsically beneficial and harmless.

In the meantime, here’s the 2013 addendum to Medicine Through the Ages:

2000 A.D. – That antibiotic is unnatural. Here, eat this root.

2013 A.D. – Has that root been assayed for adulterants, standardized for potency and purity? Has that root been approved by the FDA following clinical trials to establish dosage, efficacy and safety? Is the use of that root use evidence-based? Is it safe to take that root concurrently with other roots? Are there any contraindications? My diet already contains roots; will taking more be too much?

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