Originally published July 10 2005
Regulators wary of cosmeceuticals that allegedly fight aging and cancer
by Mike Adams, the Health Ranger, NaturalNews Editor
The FDA is holding on its approval of Agidermatics skin-cancer drug, but in the meantime the company is pouring research dollars into cosmeceuticals: A new line of drugs that supposedly enhance the appearance of youthfulness but aren't regulated by the FDA because they aren't considered drugs.
Drug companies have found a new way to make money: cosmeceuticals.
In a word, "cosmeceuticals"-an increasingly lucrative product that blurs the line between cosmetics and pharmaceuticals.
"Clinical trials are expensive, so we started to explore commercial opportunities," says founder Daniel Yarosh.
Consumers spent roughly $12.4 billion last year on cosmeceuticals: beauty products like wrinkle creams and hair-growth treatments that have druglike benefits.
Procter & Gamble says it spends more than $5 million a day developing products like Olay's Regenerist, which uses an "exclusive Amino-Peptide Complex" to minimize fine lines and age spots.
Dermatologists are also scrambling to develop their own lines, inspired by doctors like Nicholas Perricone, who has three best-selling books and a popular skin-care line.
While they may incorporate the same ingredients, cosmeceuticals are not considered drugs by the FDA and therefore aren't regulated or subject to rigorous standards of scientific review.
That's because cosmeceuticals aren't used in the diagnosis or treatment of disease; nor, in FDA parlance, are they intended to affect the "structure" or "function" of the human body.
More than 100 cosmeceutical products, from Bath & Body Works' sunscreen to Bobbi Brown's "revitalizing" eye gel, now contain ingredients developed by AGI Dermatics.
Based in suburban New York, the company holds more than two dozen patents on various technologies, but its focus is on synthetic liposomes (or microscopic sacs), developed to penetrate the top layer of skin, then release proteins and other ingredients to help repair sun damage.
The company is private, but Yarosh says annual sales are approaching $20 million.
While it's not yet profitable, commercial revenues have helped finance testing of its cancer-fighting drug, Dimericine, which in clinical trials was shown to reduce the formation of cancer-causing mutations in skin cells.
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