FDA warns against use of Herbal Doctor Remedies’ medications

Although Senator Orrin Hatch, D-Utah, is leaving the senate after 40 years of service, his legacy remains in the “Dietary Supplement Health and Education Act of 1994” or DSHEA. This may sound like an innocent, old law, but the effects of this legislation continue to reverberate through the United States and not in a positive way.

Essentially, the DSHEA, or “Hatch Act” as it is sometimes called, removed “vitamins, minerals, herbs or other botanicals; amino acids, other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients” from requiring FDA approval prior to marketing.

Other medications are required to be proven both safe and effective with scientific studies as reviewed by the FDA, but dietary supplements, thanks to the DSHEA are not. Who benefited from this legislation? Not coincidentally, the dietary supplement industry, which is well implanted in the state of Utah, and which had proven to be a major campaign contributor to Sen. Hatch prior to and after passage of the DSHEA. Once the legislation passed, the dietary supplement industry nationally exploded from a $9 billion industry in 1994 to a $35 billion industry in 2017. There has been a massive proliferation of outlets and supplement products, none of which are required to be either safe or effective. In fact, there is a disclaimer on the products that boldly states “This product is not intended to diagnose, treat, cure or prevent any disease.”

If these products were safe, but just ineffective, then the hapless consumer would simply be out a few bucks. Sadly, the absence of oversight and regulation has allowed the multiplication of products that are neither safe nor effective. Around 800 supplements were analyzed, and the report was published in JAMA Network Open. These included products for sexual enhancement, muscle building and weight loss, among others. Around 80% contained one active pharmaceutical agent and 20% contained more than one active ingredient. Around 4% contained three or more active medications and these included weight loss medications, antidepressants, NSAIDs, and anabolic steroids: all of these agents are regulated by the FDA under normal circumstances. Weight loss agents have been particularly adulterated and many of those active agents (including ephedrine, sildenafil, fluoxetine, phenolphthalein and sibutramine) have provoked forced or voluntary withdrawal of the supplements by the FDA due to dangerous or fatal reactions. In fact, reactions to supplements cause 23,000 ED visits and result in more than 2,000 hospitalizations annually.

The DSHEA opened the door for legalized quackery. Snake oil emerged from the shadows to take its place on the shelf of innumerable supplement shops and legitimate pharmacies. Currently, more than 50% of adults in the U.S. consume some sort of dietary supplement. Policing these “supplements” post-production has proven a public health disaster since an “innocent until proven guilty” policy has proven difficult to enforce and counterproductive. Dr. Peter Lipson, an opponent of the DSHEA, remarked in 1994 that “the DSHEA, as it was written and as it was intended, facilitates the legal marketing of quackery.” Senator John McCain tried to mandate reporting of side effects related to supplement use, but the supplement industry and its supporters briskly and effectively opposed his proposal.

So what can be done? The economic forces supporting the continued deregulation of dietary supplements have grown so powerful that meaningful change to the legislation appears unlikely. Consumers, however, must be aware of the dangers and remain vigilant. The FDA may be forced to continue its after-the-fact reviews of dangerous products that are often neither safe nor effective. Despite voluntary recalls, it turns out that less than half of those products are truly withdrawn from the market.
Everyone must be aware that the Latin phrase, “caveat emptor (buyer beware)” still holds true, especially in so far as nonprescription supplement products are concerned. The internet is rife with false claims and you must seek advice from your medical provider (who preferably is not selling any snake oil himself).