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Medical Forum / General / General / October 2007Ingredients list for a new drug
Now, this is interesting. There is a skin cosmetic on the market called 'La Mer' that's making huge amounts of money for the manufacturers - partly because it is vastly overpriced. According to their puff the cream is: " The highly potent Miracle Broth™ is the heart of Crème de la Mer. A blend of sea kelp, calcium, magnesium, potassium, lecithin, iron, Vitamins, C, E and B12, plus oils of citrus, eucalyptus, wheat germ, alfalfa and sunflower go into the broth, but its "miracle" lies in the way these ingredients are combined - a process called biofermentation. This 3-4 month process results in a whole far greater than the sum of its parts, with the power to transform the skin's appearance. " Obviously the site ( http://www.cremedelamer.com/home.tmpl ) goes out of its way to avoid making specific claims, but I think that the text above does suggest that it is claimed to be a new drug. The claim is that the fermentation process produces something that actually 'transforms the skin's appearance'. This must be a claim that the ingredients change chemically into a new drug. After all, only drugs actually have such measureable effects on people. There doesn't seem much on the site about side-effects. Clearly if, as claimed, this 'actually works' then, as a drug, it must have side- effects. Also, of course, as a drug, it must be tested properly, licensed by the FDA and, when sold, contain a list of actual ingredients. What is the process of ensuring that? >Now, this is interesting. There is a skin cosmetic on the market >called 'La Mer' that's making huge amounts of money for the [quoted text clipped - 10 lines] >its parts, with the power to transform the skin's appearance. >" Wow, what a description! But since it does not make a health claim, it is not a "drug", and thus is not subject to FDA regulation. Write your congressman. It's not the FDA's fault. bob > On Thu, 25 Oct 2007 00:01:25 -0000, Peter Brooks > [quoted text clipped - 20 lines] > > Write your congressman. It's not the FDA's fault. I think it does make a number of claims: 'highly potent' - this is a claim that the substance has an actual, and large, effect 'power to transform the skin's appearance' - this is a claim that an objective measure of the skin's appearance will show that this produce alters it. 'miracle...ingredients...combined...biofermentation' - this is a claim that there is a real effect (so evident that it is suggested as being 'miraculous'), caused by the chemical change to the ingredients. You could, truthfully, say this about another drug, alcohol, which has a 'miraculous' effect on the brain, caused by the fermentation of the combined ingredients (water and sugar). The claim for alcohol can be proven. >> <Peter.H.M.Bro...@gmail.com> wrote: >>> Now, this is interesting. There is a skin cosmetic on the market [quoted text clipped - 33 lines] > combined ingredients (water and sugar). The claim for alcohol can be > proven. These kind of claims are often made, and then there's a small disclaimer in the corner of the print ad, or some fast-talking announcer says that the substance in question is not intended to diagnose or treat any disease. They may be in compliance with the letter of the law, but certainly not the spirit. For me, I wonder why some biologically-active substances (for example DHEA, which if I remember correctly is a precurser to some steroid substances) can be sold as a food supplement. Steve  SignatureMark & Steven Bornfeld DDS http://www.dentaltwins.com Brooklyn, NY 718-258-5001 On Oct 25, 5:29 pm, Mark & Steven Bornfeld <bornfeldm...@dentaltwins.com> wrote: > >> On Thu, 25 Oct 2007 00:01:25 -0000, Peter Brooks > [quoted text clipped - 45 lines] > DHEA, which if I remember correctly is a precurser to some steroid > substances) can be sold as a food supplement. There are some genuine difficulties. Steak contains protiens that break down to amino acids that are precursors to steroids, hormones - you name it! I'm happy for steak not to be listed as a drug, though. In some countries DHEA is no longer listed as a food suppliment because of its drug status. I know that it isn't simple, but, the difference between a drug and a cosmetic should be fairly clear. A drug is active, a cosmetic is not. So I'd want to see cosmetics that have vitamin E as an ingredient listed as drugs, for example, because that is active. This is important as drugs, like vitamin E, have side-effects that users must be aware of. It should not be so easy to slide away from responsibility. If I have a site flogging brand X snake oil, then, fair enough, I can say that it is useless and only to be used for greasing snakes, any suggestion to the contrary being simple user misunderstanding etc.etc... However, if, on the same site, I reproduce 'user endorsements' saying 'this miracle snake oil has changed my life', then I must, at the very least, accept that I have an intent for readers to infer from this that it has some active use - unless all the 'user endorsements' make it clear that their life has only been changed insofar as they now have better lubricated snakes. If a person of normal reading age is led to believe that the stuff might make your hair grow or make you objectively less ugly, then, I'd say, that can be the intention of the vendor of brand X and that vendor must take responsibility for it. If these 'user endorsements' suggest that brand X snake oil has a 'miraculous effect' on, say, ugliness, then, even though we know miracles do not exist, we do know that, in common speech, such a statment means that it has an effect as if a drug. >> But since it does not make a health claim, it is not a "drug", and >> thus is not subject to FDA regulation. >> >> Write your congressman. It's not the FDA's fault. >> >I think it does make a number of claims: What you think really does not matter. It is a matter of law, and the FDA is restricted from dealing with these things. Read up on how the FDA works. (I agree with your intentions. But you are misplacing your concerns.) bob > (I agree with your intentions. But you are misplacing your concerns.) Where should I be placing my concerns then? >> (I agree with your intentions. But you are misplacing your concerns.) >> >Where should I be placing my concerns then? Congress. They make the laws under which the executive branch acts. They also set the funding -- which can confine what an agency does that might be inclined to interpret its mandate too broadly. You might want to make contact with your own Representatives office. Obviously, when you find out which side that person is on, you can decide whether it is fruitful to work with him/her. But go read up on the legal situation. That will give you the background, in proper language. Don't rely on my overview of it. bob
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