June 28, 2005 When Is An Anti-aging Cosmetic A Drug? A major multi-million dollar class action suit was filed in federal court recently against a web of companies promoting their products as combating aging skin or overweight. The action filed by the law firm of Meiselman, Denlea, Packman, Carton & Eberz "seeks to redress the pervasive pattern of fraudulent, deceptive, and otherwise improper marketing and advertising that defendants are engaging in with respect to their numerous alleged dietary supplements and topical preparations purportedly designed to improve body appearance." The difficult question is when is a cosmetic also a drug product? If it really affects the structure of the body than it is a drug, according to FDA regulations. If it does not and claims to do away with wrinkles, for example, then it the advertising is fraudulent. If the cosmetic companies want to add an "active ingredient" to a product, they should file a new drug application---a very, very expensive proposition. If they don't and the FDA or the Federal Trade Commission comes after them, it might take years to bring the cases to court and in the meantime, companies will have sold consumers millions of dollars worth of products that may or may not be useful. The stakes are high. The aging baby boomers are predicted to trigger an 8.7 percent annual increase in the market for anti-aging products which is likely to give the category a total value of $30.7 billion by 2009, compared to an estimated value of $20.2 billion in 2004. Fueling the market increase, according to the Freedonia Group, will be a series of new and improved products that claim to offer both health maintenance and appearance enhancing benefits to the first of the baby boomer generation now entering the over 50s age group. New scientific developments, indeed, are enabling some so-called cosmeceuticals to really do what they claim---decrease wrinkles or age spots Since the government agencies are not sufficiently equipped to deal with the truth behind the anti-aging products, it is up to you to become knowledgeable about products that may give you your money's worth or just reduce your pocketbook rather than your wrinkles or weight. WHAT TO TAKE ON A SPACE TRIP VACATION Soon, tourists will be take a trip on a space rocket but those who can afford the fare will most likely be older. What medications should they take with them and who will offer medical care if needed? Eleanor A. O'Rangers, Pharm D., spoke recently at the Second Annual Medical Seminar of Scientific Advantage LLC, in Bridgewater, NJ. Her topic was "Pharmacokinetic and Pharmacodynamic Aspects of Space Flight". In an interview after her presentation she said the tourists will probably have to lie down in the craft and the attendants will have to be ready with medications and devices if weightlessness causes circulatory problems. A consultant for NASA, she has no doubt that there will soon be space tourists for short trips and pharmaceutical companies are working with NASA on drugs for space use. In the meantime, she said, we can all be grateful to NASA for medical innovations developed for space but now used on earth. For example: The above spin-offs from earlier space research are great but today, Dr. O'Rangers says, she would not be a space tourist because the shuttles are old. "Constrained bureaucracy funding is not providing the funds to give due diligence to space shuttle safety".
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