Supplements and DSHEA under mass attack

By Lorraine Heller

- Last updated on GMT

Supplements and DSHEA under mass attack
The US dietary supplement industry is facing a massive media onslaught after recent recalls of harmful products have placed the sector and the law that regulates it under the spotlight.

Below is a summary of some of the articles that have appeared in the consumer press over the past two weeks.

Next week, NutraIngredients-USA.com will invite an FDA legal specialist to take a closer look at recent events within the context of the Dietary Supplement Health and Education Act (DSHEA).

LA Times

A blog posted yesterday on LA Times ​sums up the growing consumer skepticism of dietary supplements and DSHEA.

“The 1994 passage of the Dietary Supplement Health and Education Act paved the way for a marketplace in which manufacturers of dietary supplements can churn out pure trash,”​ states a blog.

“It's time to re-examine the farcically named Dietary Supplement Health and Education Act (just how is this educational?) and implement laws that prevent consumers from becoming guinea pigs for unscrupulous kitchen chemists.”

Click here​ to read the LA Times ​blog.

Sports Illustrated

This follows on from an article in Sports Illustrated​, which repeats claims that “the industry has become (…) a Pandora's Box of false claims, untested products and bogus science”.

“In 1994 Congress passed the Dietary Supplement Health and Education Act, which allowed supplements—broadly defined as vitamins, minerals, herbs, amino acids and other products that don't contain approved pharmaceutical drugs and don't claim to treat diseases—to be sold with no proof of effectiveness or safety, and without approval from the FDA,” ​continues the article.

“That legislation, heavy with lobbyists' fingerprints, razed virtually every barrier to entry into the marketplace.”

Click here to read the Sports Illustrated ​article.

SFGate

An article by renowned nutrition professor Marion Nestle, published early this week in SFGate.com ​states: “In the supplement world, lack of scientifically proven effectiveness has little relevance. Neither does safety.”

DSHEA, she said, was drafted by the supplements industry and resulted in the deregulation of these products.

“Congress passed DSHEA on the basis of two quite questionable assumptions: that supplements are basically harmless, and that supplement-makers are basically honest.”

“The law does not require supplement manufacturers to demonstrate the safety or effectiveness of their products to the FDA before selling them. Instead, the FDA must prove a supplement harmful by providing documentation from clinical trials or multiple case reports in court - a tedious process,” ​claims Nestle.

Click here​ to read the SFG.com ​article.

FASEB

An article published last week in The Journal of the Federation of American Societies for Experimental Biology (FASEB), states: “Unfortunately, the $24bn/year ‘dietary supplement’ industry peddles subprime concoctions that can only be recalled after​ someone blows a whistle.”

It goes on to state that since 1994 FDA “has had no effective regulatory authority over dietary supplements, unless these nostrums cause harm or are doped with prescription drugs”.

The article’s author, Gerald Weissmann says that DSHEA allows manufacturers to describe a supplement’s effects on the structure or function of the body without substantial scientific proof, and without being required to carry drug-style warning labels.

Click here​ to read the FASEB​ editorial.

Herald Tribune

Another article that appeared last week in the Herald Tribune ​maintains that FDA has been “hampered” ​since the passage of DSHEA in 1994, when it warned of the seriousness of reported adverse events and their increasing number.

“Little has changed since then, except the names of these unregulated products and their ingredients (…)”

“Consumers deserve better. The supplement act should be changed to give the FDA adequate authority to ensure that the multibillion-dollar supplement industry meets essential safety standards.”

Click here​ to read the Herald Tribune ​article.

Star Tribune

An article in the Star Tribune ​paints a similar picture:

“Thanks to a 1994 law that leaves this $22 billion-a-year industry far too lightly regulated, supplement manufacturers don't have to provide scientific proof of a product's purity, safety or effectiveness before they put it on the market,”​ it sates.

“Instead, the FDA generally steps in after ​problems are reported. If you're swallowing a supplement, congratulations: You're a test subject and part of a vast experiment to see if this stuff is safe.”

Click here​ to read the Star Tribune ​article.

Related topics: GMPs, QA & QC, Suppliers, Product claims

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