Should regulators treat the supplement industry like the tobacco industry?

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Posted 21 December 2015

Scott Gavura, a pharmacist, has posted an excellent article on his blog ‘Science-Based Pharmacy’, in prompted by an article titled “Should states and local governments regulate dietary supplements?” published in the journal, Drug Testing and Analysis. (abstract reproduced below)

He writes:

“The idea that “natural” products are safe and effective has been so effectively marketed to us that many don’t recognize it as a fallacy. Much of the supplement industry is built around an appeal to nature. Supplements are described as natural, gentle, and “holistic”. Medicine, especially prescription drugs, is the opposite. They’re “chemicals”. They’re risky and dangerous – just look at that list of side effects!”.

He states: “Supplement regulation: A travesty of a mockery of a sham of a mockery of a travesty of two mockeries of a sham” and points out this cautionary tale:

“Claims made about the efficacy of herbal remedies are typically based on ‘history of use’ claims but often fall short in terms of anything that’s convincing, whether it’s small trials, bad study design – or the fact that it’s not even clear what chemical constituent is having an effect – and if it’s in the dose at all. Without close evaluation, and a standardized product, it’s very difficult to determine if herbal remedies are effective or harmful. The story of Aristolochia is cautionary and telling.  Aristolochia is a plant that has been considered to have medicinal properties for hundreds, perhaps thousands of years. Owing to its resemblance to a uterus it has been thought to be effective for childbirth (that’s herbalism “evidence” for you) and has been used as part of traditional Chinese medicine for a number of conditions, none of which were supported by any evidence. The harms of this botanical weren’t identified until recently; when a cluster of Belgian women developed kidney disease and urinary cancers after taking Aristolochia-containing diet pills, the catastrophic harms were revealed. Aristolochia promotes cancer formation through DNA mutations. It’s now classified as a type 1 carcinogen, alongside asbestos and solar radiation”.

He asks whether  states can learn from tobacco regulation, and points out that “Given the likelihood of robust federal consumer protection regulation is remote, the focus has shifted to the potential for state-level action to improve patient safety. It’s worth noting that this is already occurring. Earlier this year the New York State Attorney General issued letters to several retailers demanding that sales cease of mislabelled store-brand supplements”.

This is a though provoking article, as usual, and worth reading.

Should states and local governments regulate dietary supplements?

Ranjani Starr*

Drug Testing and Analysis

Article first published online: 23 November 2015

Abstract

Federal regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act of 1994. The law has been criticized as weak and ineffective. Alarming research has emerged demonstrating that supplements may be mislabelled, contaminated, adulterated with dangerous or unknown compounds, or sold at toxic doses. As a result, the health community has raised concerns about the safety and quality of dietary supplements. Increased federal oversight is an important avenue for improving supplement safety; however, states and local governments may also pursue strategies to strengthen the overall regulatory control of dietary supplements. States and local governments have substantial experience in regulating other products that pose a risk to public health, such as tobacco. Additionally, much has been learned about the tactics the tobacco industry has employed to protect its interests. Lessons learned may be applied to new regulatory efforts aimed at improving the safety of dietary supplements at the state and local levels.

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