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NEW YORK — Do dietary supplements need more regulation?
Dr. Pieter Cohen, an outspoken critic of the dietary supplement industry from the Harvard Medical School in Boston, believes the answer is a resounding yes.
He has written and spoken on the issue extensively.
Last January, Cohen was a guest on the "Dr. Oz show," a show that features Mehmet Oz, a doctor who became famous for his appearances on "Oprah."
Weeks after Cohen appeared on the "Dr. Oz Show," the New England Journal of Medicine published an editorial perspective by him titled "Assessing Supplement Safety — The FDA's Controversial Proposal."
Zotrex is an example of a "drug analog," which is usually prepared by taking derivatives of existing drugs by modifying their chemical structure to varying degrees.
In the NEJM editorial perspective, Cohen made an oblique reference to a Salt Lake Valley company, NovaCare LLC, as the poster child for why the dietary supplement industry needs more regulation. Cohen did not specifically name the company, but referred to NovaCare as “a well-respected dietary supplement company" and then launched into how the company "announced the recall of Zotrex,” one of its dietary supplements to improve men’s sexual function.
The Food and Drug Administration conducted an inspection of NovaCare in March 2010.
On August 11 of that year, NovaCare announced on the Natural Product Insider website “a voluntary recall of 21 different products after the FDA informed the company the items, marketed as dietary supplements, were found to contain an undeclared drug ingredient. Under federal law, the presence of undeclared drugs in a product marketed as a dietary supplement makes such a product both adulterated and misbranded.”
After the inspection it took the FDA over eight months until December 28, 2010 to confirm the violations and to issue an enforcement action in the form of a warning letter to specifically outline the company's violations. The company had already voluntarily recalled those products prior to the FDA's letter.
Zotrex is an example of a "drug analog," which is usually prepared by taking derivatives of existing drugs by modifying their chemical structure to varying degrees.
Cohen said, "These drugs have never been tested on humans; we are human guinea pigs."
NovaCare is not the only dietary supplement company with a similar violation for using a Viagra analog. In 2011, for example, Intelli Health Products LLC in Odessa, Florida also had a similar violation associated with a Viagra analog.
Cohen claims that, based on the FDA's own records, "by the time of the recall, NovaCare had distributed nearly 14 million capsules containing, among other things, sulfoaildenafil, under a variety of trade names, including 'Stiff Nights' and 'OMG'), and thousands of customers may have inadvertently consumed the untested (analog)."
When contacted about the recall, NovaCare company spokeswoman, Sharon Silkman, declined to comment. She said she would inform the company CEO who, if he had anything to say, would contact ksl.com. Three weeks later, there has been no response from the company.
Unlike many companies, the NovaCare website does not identify the CEO of the company. At the time of the recall, the company CEO was Kelly D. Harvey.
The dietary supplement industry is regulated by the Dietary Supplement Health and Education Act, which was enacted in 1994.
Basically, companies have introduced new (dietary) ingredients and the FDA has done very little about it—there has only been silence from the FDA as these new ingredients have entered the market.
–Peter Cohen.
DHSEA stipulates that for new dietary ingredients — specifically those introduced after 1994 — manufacturers must provide the FDA with evidence supporting a “reasonable expectation of safety.”
“Basically, companies have introduced new (dietary) ingredients and the FDA has done very little about it—there has only been silence from the FDA as these new ingredients have entered the market,” Cohen said to ksl.com.
According to Consumer Reports, "Both the Supplement Industry and the FDA acknowledge that many new products have been introduced with no assessment of safety."
According to the NEJM editorial perspective “Zotrex represented a particularly brazen violation of the law.”
Cohen wrote in his editorial perspective that, “Since DSHEA became law the number of dietary supplements has skyrocketed from an estimated 4,000 to more than 55,000.
“The FDA has received adequate notification of only 170 new supplement ingredients since the 1994 law was implemented.”
Cohen adds, “Undoubtedly, (this is only) a small fraction of the ingredients for which safety data has been submitted.”
To address the issue, the FDA has proposed new guidance to regulate "New Dietary Ingredients " and increase the safety of dietary supplements.
Cohen says the new guidance would clarify the level of evidence the FDA would use to assess safety and establish “a sound scientific framework for evaluating the safety of new ingredients.”
Ideally, Cohen said “the FDA should require more."
"In the absence of significant modifications, the FDA's guidance may have the effect of providing a false sense of security to consumers seeking safe dietary supplements,” Cohen writes.
According to Cohen’s editorial perspective in the NEJM, the recommendations would lead to “a substantial improvement in safety.”
The supplement industry has vehemently been attacking the new proposal and overwhelmed the FDA with more than 146,000 pages of comments arguing the guidance and proposed oversight by the FDA is “overly stringent and should be withdrawn.”
Meanwhile, Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) have written a letter on behalf of the supplement industry to FDA Commissioner Margaret Hamburg to urge the withdrawal of the NDI Draft Guidance.
In the letter to the FDA commissioner, Hatch and Harkin — the principle authors of DSHEA — asked Hamburg to immediately withdraw the agency's controversial draft guidance on new dietary ingredients and begin work on "a new draft that will provide needed clarification on what constitutes an NDI, but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products."
Cohen’s fear is that the FDA not only did not go far enough, but that it may succumb to industry pressure. He says, "the public health consequences would be significant."
In his editorial perceptive Cohen suggests the FDA should require scientific evidence that demonstrates the, expectation of safety and urges the FDA to create a database of evidence that scientists, physicians, regulators and consumers could utilize to make informed decisions about the use of supplements in the future.
"Even if the guidance and the proposal is strengthened and aggressively implemented, the lack of pre-approval processes will continue the limit the FDA’s ability to ensure dietary supplements are safe.” said Cohen.
Mel Borup Chandler writes on science and technology. He reports from Southern California. His E-mail is mbccomentator@roadrunner.com.
