One-Two Punch On Supplements From Former FDA Investigator, Harvard Researchers

Jeff Novitzky, VP of athlete health and performance at Ultimate Fighting Championship, discusses violative supplements at a Dietary Supplement Caucus briefing for lawmakers and congressional staff. Harvard researchers roundly criticize the products' potential health benefits.

Former FDA investigator Jeff Novitzky turns his attention from labs that supply athletes with steroids and other banned performance-enhancing products to firms that offer consumers drug-spiked dietary supplements.

Meanwhile, Harvard University researchers broadly caution consumers against using supplements and roundly criticize marketing that promotes the products' potential health benefits.

Novitzky, vice president of athlete health and performance at Ultimate Fighting Championship, spoke on April 14 on Capitol Hill at a Dietary Supplement Caucus briefing for lawmakers and congressional staff. The event was not announced publically in advance and media did not attend.

In a statement released when he joined UFC in April 2015, Novitzky said supplement products are "one of the scariest areas out there right now in terms of our program and our athletes. There are hundreds of products out there that an athlete could use and unknowingly be using a banned substance."

"It’s very scary. I worked with the FDA the last seven years, and I saw that industry from the inside out – and it scares me a lot," he said.

Novitzky discussed adulterated supplements at the Capitol Hill briefing, saying most professional athletes take supplements to augment the nutrients they get from food. However, he said "some irresponsible companies sell tainted products, harming the reputation of the industry as a whole," according to the event organizer, the Natural Products Association.

Novitzky joined the UFC mixed-martial arts organization to lead development of a program to prevent competitors from using performance-enhancing drugs or other substances that could be formulated in some supplement products.

Previously as a special agent with the Internal Revenue Service and FDA, he led investigations into labs suspected of supplying steroids to athletes including Barry Bonds, Roger Clemens, Marion Jones, Lance Armstrong and others.

According to NPA, at UFC Novitzky "has crafted and implemented the strictest drug-testing program in professional sports conducted by the U.S. Anti-Doping Agency."

UFC says with Novitzky leadership, it will "continue to invest in state-of-the art sports science studies, further develop its out-of-competition PED testing policy and enrich its education and prevention programs."

Novitzky's investigations and information from other sources led members of Congress in 2008 to conduct a hearing on the use of PEDs in Major League Baseball. A statement by an MLB Players Association executive that some players may unintentionally ingest banned substances in supplements with undeclared ingredients prompted industry ally Sen. Orrin Hatch, R-UT, to write an op-ed article denouncing pro athletes for blaming their use of banned substances on adulterated supplements (Also see "Hatch Denounces Blaming Supplements For Steroid Violations" - Pink Sheet, 18 Feb, 2008.).

A year later, USADA launched an alliance pushing for legislative changes for stronger enforcement against steroid-containing nutritional supplements. Major sports associations threw their support behind USADA's "Supplement Safety Now," but it and other efforts aiming primarily to require some form of pre-market approval for supplements have failed to gain traction in Congress (Also see "USADA Builds Team To Change Supplement Law, Cites "Lax" Regulations" - Pink Sheet, 7 Dec, 2009.).

Supplements' Quantity, Quality Criticized

Harvard Medical School on April 20 published a Harvard Women's Health Watch article on the quantity and quality of supplements available in the US, noting that David Eisenberg, adjunct associate professor at the university's T.H. Chan School of Public Health, documented the use of alternative therapies in the US in a 1993 article in the New England Journal of Medicine.

Eisenberg and his colleagues found at that time that more than a third of US consumers were using "unconventional therapies, largely for chronic conditions," including treatments such as acupuncture as well as herbal remedies and other supplements, most without telling their physicians, according to the Women's Health Watch article.

"The value of most herbs and supplements has been discounted or remains unproven. Few are worth the money spent on them. Moreover, there is no guarantee that the pills, capsules, or tablets contain all – or even any – of the ingredients listed on the packaging," wrote the authors of the Women's Health Watch article.

The article quotes Eisenberg on concerns that FDA and other public health officials have stated about consumers delaying needed medical care by relying on supplements promoted with violative claims to prevent or cure diseases.

“Some non-vitamin supplements are marketed heavily in the absence of reliable evidence of efficacy or safety and may interact with prescription drugs. Moreover, some people may delay beginning proven therapies because they are relying on supplements. And some of these products are costly,” said Eisenberg.

The Harvard publication also notes that supplements used in government-funded clinical studies are analyzed for purity and standardized for dose and manufacturers are required under FDA's good manufacturing practices regulations to perform those analyses on their ingredients and products.

The researchers point out too, though, that numerous reports have said "few of the thousands of supplement manufacturers" comply with GMPs and "FDA lacks the staff and resources to analyze supplements or to compel manufacturers to comply."

While supplement labels instruct consumers to consult a health care professional about using a product, the Harvard researchers recommend talking to a doctor before buying a supplement.

"If you truly need a vitamin or other dietary supplement, your clinician can suggest an appropriate product and dose," they wrote.

From black cohosh to omega-3 fish oils, the researchers assailed supplement labels claims for benefiting users' health.

Additionally, "supplement stores abound with products that promise to make exercise easier and promote weight loss," but those also "are unproven, and some may contain stimulants that are harmful when used for extended periods," according to the Harvard researchers.