By Len Monheit
As January comes to a conclusion, we’re still waiting on GMPs, and soy's cholesterol benefits are questioned, leading to speculation in some cases that the health claim might be reviewed. A review of several studies involving omega-3’s and lack of confirmed evidence of risk reduction of various types of cancer is published, receiving widespread pickup. Consumerlab.com releases another review, this time on sexual enhancement products, and increasingly receives pick up in the news for past announcements, often in the same sentence as the words ‘can’t trust what’s in the bottle’ and ‘unregulated industry’. It's not an ideal environment, but not new – we’ve seen all this before. This is all part of the background noise we’ve become accustomed to as we operate in this industry. There are a couple of things brewing though, that are a bit ‘new’.
H.R. 4282, the Health Freedom Protection Act, continues to carry some momentum. Recent setbacks for Qualified Health Claim submissions and frustration at not being able to talk about pain, cholesterol, joints and use other ‘disease-related language’ despite scientific substantiation, in many cases, has been extremely frustrating and discouraging. The apparently heavy-handed manner in which the regulatory agencies (FDA and FTC) are dealing with companies trying to push the envelope is fueling support for the legislation. Health care cost reduction and inefficiencies in the current health environment mean that drastic change - fundamental policy change - is required.
Is legislative change such as H.R. 4282 the best means? Many I’ve spoken to see a vision of unrestricted language, and in the current regulatory environment, grossly inadequate resources still prevailing for FDA to enforce the huge abuses a more open environment will likely encourage. When one considers even the current behavior of some of the irresponsible companies touting themselves as legitimate supplement companies, if these organizations are given still more latitude and ‘freedom’, I shudder to think about some of the results. Part of the argument in favor of the legislation, though, asks why legitimate responsible companies with compelling science should be penalized for the activities of irresponsible companies with little such commitment. It is increasingly obvious that something has to give, especially where there is continuing evidence that the current system is not working.
On another note, the FDA's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend that the FDA approve Glaxo Smith Kline’s Orlistat 60 mg capsules for over-the-counter (OTC) use in the U.S. (Forbes article http://www.forbes.com/2006/01/24/gsk-fat-pill-cx_gl_0124autofacescan05.html) According to the Forbes coverage, the product, marketed under the name Alli, would be indicated for use by overweight adults along with a reduced calorie, low-fat diet.
It’s interesting to note that the precautions listed for Xenical (the 120mg version of the drug, slated to remain available by prescription only) include ‘Xenical can decrease the absorption some fat-soluble vitamins and beta-carotene. Therefore when being treated with Xenical, take a multivitamin supplement that contains vitamins D, E, K, and beta-carotene. Take your multivitamin once a day at least 2 hours before or after taking Xenical, such as bedtime.’
I’m a bit perplexed as to why a half dose is slated to ‘go OTC’ while essentially a double dose requires a prescription. One might cynically guess that the logic follows something like ‘we know that individuals will only consume by responsibly following label instructions.’ One would also guess that the precautions recommending vitamin supplementation, indicated for Xenical either don’t exist for the ‘half-dose’, or will also be followed automatically by consumers. (One can certainly understand why the FDA panel had some doubts about this approval.)
I’m very curious to see what implications this event has for our industry and for the weight management supplement category in particular. We know that knock-off products masquerading as supplements will be aggressively promoted. We know too that in the past, when pharmaceutical companies aggressively enter a category, as in any competitive environment, they seek to deter rival approaches.
There’s a certain irony emerging in both of these issues as the heads of regulatory agencies around the world call for personal responsibility for health and wellness. On the one hand, stifling of language prevents individuals from learning what they need to in order to exercise increased control of their personal health and wellbeing. In the other case, another magic bullet (an OTC product) has been provided to those looking for quick fixes, without requiring fundamental lifestyle change in order to allow these consumers to be truly healthier.