Is another FDA ban imminent?

Will the FDA ban another "new drug" that's been in use for generations?

Posted September 21, 2006 5:50AM PDT
Updated 11:03PM PDT

The fun news today is that there has been an apparent breakthrough in sunless tanning technology:

"A small molecule applied to the skin of red-haired, fair-skinned mice essentially rescued the pathway and allowed the mice to darken. The reactivation of that pathway was protective to the mice," said the study's lead author, Dr. David E. Fisher, director of the Melanoma Program at the Dana-Farber Cancer Institute in Boston. "What we're learning will hopefully be leading us to new strategies for skin-cancer prevention." — Rub On a Tan and Prevent Skin Cancer?, Forbes, September 20, 2006

That "small molecule" is forskolin, which is derived from the root of Coleus forskohlii, a member of the mint family. I don't know if this is the same Coleus plant you can buy at the local garden shop, but don't be surprised if the FDA clamps down on it, soon. For safety reasons, of course:

"I think it will be a while before we have a cream that can safely increase melanin in the skin," said Dr. Seth J. Orlow, chairman of the department of dermatology at New York University Medical Center in New York City. "I think this study was carefully done, but we would be well advised to temper any enthusiasm." — Rub On a Tan and Prevent Skin Cancer?, Forbes, September 20, 2006

Just one thing. It's been around and in use for a long time:

Forskolin has been extensively researched in the medical field for use in the treatment of allergies, respiratory problems, cardiovascular diseases, glaucoma, and many other conditions. It has also recently gained popularity as a fat loss agent. — Forskolin, Great Vista Chemicals

In India, it has recently been approved for use in treating glaucoma:

Sabinsa received approval Wednesday for a plant-derived glaucoma drug, Ocufors, from Indian regulatory agencies. … While it's the first pharmaceutical product derived from a plant to be approved in India, it is also the first such eye care product worldwide. … Ocufors is made from Forskolin, an extract prepared from the herb Coleus forskohlii, a member of the mint family of plants that grows wild in some parts of India. … Ocufors has been found to be 30 percent more effective that existing and popular glaucoma drugs. — India Approves Glaucoma Drug, Red Herring, September 6, 2006

Follow the money

Great, so it's been approved by India's equivalent of the FDA, but that means nothing in America, where the FDA is run to benefit American drug manufacturers, not the American people:

For decades, the pharmaceutical industry has sought to limit competition by trying to get the FDA to regulate high-potency supplements as drugs. It was only because of intense consumer backlash that Congress passed legislation that protected the free sale of most supplements in the United States. … For those who have battled to protect health freedom, the introduction of an overpriced prescription fish oil drug provides absolute proof that every letter to Congress was well worth sending. … The FDA granted the approval based on the company-sponsored clinical study showing that fish oil does exactly what it had previously been shown to do—that is, lower triglyceride levels. — Fish Oil Now Available By Prescription!, by William Faloon, Life Extension Magazine, September 2006

Nutritionally savvy consumers have been supplementing their diets with Omega‑3 fatty acids and more for many years. During all that time the FDA, driven by the pharmaceutical industry, has attempted to ban over‑the‑counter sale of everything from vitamin C to tryptophan and ephedra. In the 1980s the FDA did ban sale of tryptophan, the amino acid found in milk that the body converts to serotonin, and in 2004 it banned sale of ephedra.

The ban of tryptophan coincided with Eli Lilly's introduction of Prozac, and the ban on ephedra coincided with Eli Lilly's marketing efforts to boost sales of Strattera. Eventually the ban on tryptophan was quietly lifted, but at much higher prices that make the insurance‑subsidized price of Prozac the cheaper alternative. Supplement manufacturer Nutraceutical Corporation filed and won an expensive lawsuit to overturn the ban on ephedra, but proving the power of the Drug Lobby, which preys on and profits from the conditions that are helped if not healed by cheap nutritional supplements, the ban was upheld:

A federal appeals court has overturned a Utah ruling that challenged the FDA ban on products containing weight loss and sports performance herbal ephedra, making it more unlikely than ever that the US market for the ingredient will resurface. — US appeals court upholds ban on ephedra, By Clarisse Douaud, August 21, 2006

Why does this suggest that the FDA will ban forskolin, or at least clamp down on over‑the‑counter sales with heavy‑handed regulations? Because it's relatively cheap, readily available, and once word gets out how many benefits it provides in addition to probably saving millions of Americans from skin cancer, demand for it will hurt sales of expensive prescription drugs.

And if there's one thing that the FDA has demonstrated, it's that it gives higher priority to the profits of drug manufacturers than to the health of the American people.