Comments on: Orlistat and Hydroxycut: Similar health problems, but comparable FDA treatment?

By: FDA Deputy Commissioner Sharfstein Pledges to Work with Supplement Industry | The Nutritional and Dietary Supplement Law Blog

Mon, 26 Oct 2009 11:18:43 +0000

[...] the FDA’s handling of the recent Hydroxycut recall, something we at NutriSupLaw have previously questioned several times. The questioner noted that Hydroxycut was recalled based upon just 23 reports of liver disease [...]

By: Ann Godsell

Ann Godsell — Fri, 11 Sep 2009 14:06:09 +0000

I don’t have all the details for both situations, but would comment that the prime role of public health protection is paramount to the FDA, or indeed any health agency.

Xenical will be manufactured to established quality standards, and tox data & human exposure data available. This regulated situation allows a more scientific evaluation of the potential safety signals. In contrast hydroxycut products probably cannot be similarly evaluated. So therefore because of potential risk, FDA likely to take a more cautious approach as it is much harder to perform a risk-benefit analysis.

In the EU Alli remains as OTC Xenical (lower dose only), whereas hydoxycut products,regulated as foods, have in some countries removed from sale due to safety concerns

By: Ann Godsell

Ann Godsell — Wed, 09 Sep 2009 05:27:16 +0000

This is an interesting comparison. I don’t have all the details for both situations, but would comment that the prime role of public health protection is paramount to the FDA, or indeed any health agency.

In the EU Alli remains as OTC Xenical (lower dose only), whereas hydoxycut products,regulated as foods, have in some countries removed from sale due to safety concerns.

By: Elwood Richard

Elwood Richard — Wed, 02 Sep 2009 19:09:36 +0000

Evidence that the adverse event reporting system is flawed was proven when Bob Reynolds PhD, a leading vitamin B 6 researcher found that none of the 70 or so adverse avents on vitamin B 6 reported to the Center for Disease Control was clearly due to vitamin B 6. Leading researchers need to be involved in establishing a good adverse effent reporting problem.

The toxicity data not only needs information on dose response, but a mechanism to expalin the toxicity.
Elwood Richard, Founder Now Foods

By: JD

JD — Wed, 02 Sep 2009 13:34:48 +0000

It is clear that the FDA has a very selective pro-big pharma agenda when it comes to the “advisories” around unregulated supplements.

Until better controls are put in place to control the purity, efficacy, and long term effects of nutritional supplements, supplement makers will be the FDA’s scapegoats and their products will be viewed with skepticism and mistrust.

Why? Because there is alot of junk being peddled out there using deceptive marketing practices.

By: Weight Loss » Blog Archive » Orlistat and Hydroxycut: Similar health problems, but comparable FDA treatment?

Mon, 31 Aug 2009 22:02:35 +0000

[...] Original post by The Nutritional and Dietary Supplement Law Blog [...]