The FDA identifies mislabeling and false claims

The FDA identifies mislabeling and false claims

On April 17, 2017, the FDA sent a warning letter to the LifeVantage Corporation advising them that their product Protandim NRF2 Synergizer was misbranded and violated regulations.

The claims on the websites www.nrf2science.com, www.lifevantage.com, and www.protandim.com establish that they are selling Protandim as a drug intended to prevent or treat diseases. The claims include prevention and/or treatment of cardiovascular disease, Alzheimer’s disease, high blood pressure, stomach ulcers, osteoarthritis, bacterial and viral infections, and several types of cancer (“shows ability to slow progression of and ‘kill’ cancer cells”). And much more.

The FDA gave them 15 working days to correct these violations. As of this writing, they have not yet done so.

Protandim is a mixture of 5 herbal supplements (milk thistle, bacopa extract, ashwagandha, green tea extract, and turmeric extract) intended to upregulate the body’s own production of antioxidants. It is sold through multilevel marketing. Its patent application said it was useful to treat or prevent an astounding 126 diseases and medical conditions, from tinnitus to aging, from hemorrhoids to cancer. Those claims are not supported by any credible scientific evidence.

Previous articles on Protandim

I first wrote about Protandim in 2005, followed by three articles on the Science-Based Medicine blog. The first, in 2009, was “Protandim: Another Kind of Antioxidant.”

The second, in 2011, was “Pursued by Protandim Proselytizers.” I described how I was getting a steady flow of emails from distributors and customers asking me to reconsider and look at new evidence. I looked at the new evidence, but it was not anything that would lead me to reconsider. I wrote:

We need good human studies showing that people who take Protandim have better clinical outcomes than people who don’t. For instance, fewer heart attacks or fewer cancers…not just higher levels on a TBARS test….I am only asking for the same kind of evidence that the scientific community requires before it accepts any new treatment. Please try to understand what I mean by clinical studies with meaningful outcomes and contact me again when such studies are available… and not before.

They didn’t listen. They kept sending me e-mails every time any new study was announced. In 2012 I wrote a brief update to cover a study that was so bad it made me laugh. Instead of studying any of the conditions Protandim was alleged to benefit, they chose to study alveolar epithelial permeability in alcoholics. The results? It performed significantly worse than placebo!

The new studies are not convincing

They still didn’t listen. I’m still getting emails, most recently this one:

Hi, I’m not even sure how I came across your article against Protandim, last 1 is from 2011. Would you please have a look at the studies now. [sic] I’d love to know if your opinion has changed. Your info is incorrect by stating all the studies are done by the company. Check out the NIA study on life extension or the osteo study by Montreals [sic] Osteoarthritis Research Centre. Surely you must have something to say about these? thank [sic] you for your time.

She didn’t provide details, so I had to do some sleuthing to figure out which studies she was referring to. I found the NIA life extension study. It was in mice, not humans. It found that Protandim significantly increased the median lifespan of male mice at one of the three testing centers but not at the other two; when data from all three sites was pooled, Protandim appeared to increase the median lifespan of male mice by 7%. It did not significantly increase the median survival of female mice. And it did not increase maximum lifespan. Anyway, what happens in mice may not apply to humans.

I located the osteo study. It’s behind a paywall, and the abstract is confusing. Apparently it was a combination of a mouse study and in vitro studies. They used a mouse model where osteoarthritis was surgically induced by destabilizing the medial meniscus. Then they injected Protandim directly into the joint, and the mice’s osteoarthritis scores decreased. Nice for the mice, but it doesn’t tell us anything about humans taking Protandim in pill form! Then they studied human and mouse cells in vitro and measured improvements in Nrf2 and GSTA4-4 expression. Interesting, but not the same as significant clinical improvements in humans with osteoarthritis or any other condition.

I also found this study in human athletes showing that:

Protandim® did not (1) alter 5-km running time, (2) lower TBARS at rest (3) raise antioxidant enzyme concentrations compared to placebo (with exception of SOD in those ≥ 35 years old) or, (4) affect quality of life compared to placebo.

This study is not mentioned on the Protandim website, presumably because of its negative results.

Other critics and concerns

I’m not the only one to critique Protandim. Supplement Geek covered the research thoroughly pointing out that the studies are mostly in rodents and in test tubes; there have only been three studies in humans, two of which were negative. And Consumer Lab was less than enthusiastic. And another review cites “very little evidence.”

And there’s also a Wikipedia page that points out that the in vitro and animal studies have not been replicated in human trials. It also reveals how Protandim was invented: Joe McCord was given a list of 41 potential ingredients and he rapidly penciled out 36 of them. Not very scientific!

For what it’s worth, there was a safety recall in 2012.

And the LifeVantage company is not BBB accredited. The BBB website mentions failure to respond to three complaints and includes a number of customer comments.

There is a Protandim Watch website that lists investigative resources, but it is not up to date.

Conclusion: not backed by scientific evidence

It seems nobody is very impressed with Protandim except for the people who are selling it!

So no, my opinion has not changed. My articles are not “against” Protandim. My opinion is not that it doesn’t work, but that no one knows whether it works; and the only way to find out if it works is through proper scientific testing of the company’s claims.

The good news is that if you don’t want to wait for scientific testing, it is probably safe to try. Over the 88 days of the negative trial on human athletes there were 233 reports of signs and symptoms in the Protandim group compared to 220 in the placebo group. Subjects taking Protandim reported more episodes of stomachache and headache, and less gas, but with only 19 subjects in each group, numbers were too small to draw any conclusions.

Posted by Harriet Hall

Harriet Hall, MD also known as The SkepDoc, is a retired family physician who writes about pseudoscience and questionable medical practices. She received her BA and MD from the University of Washington, did her internship in the Air Force (the second female ever to do so),  and was the first female graduate of the Air Force family practice residency at Eglin Air Force Base. During a long career as an Air Force physician, she held various positions from flight surgeon to DBMS (Director of Base Medical Services) and did everything from delivering babies to taking the controls of a B-52. She retired with the rank of Colonel.  In 2008 she published her memoirs, Women Aren't Supposed to Fly.