In 2005, an up-and-coming pharmaceutical company made a big mistake: they invested millions of dollars into developing a drug only to discover that the only active ingredient of the drug, pyridoxamine, was really a common, naturally occurring substance that has been sold for decades at low cost to consumers in the form of a dietary supplement, and has always been available in commonly consumed foods such as chicken and brewer’s yeast.
We’re taught as children that when you make a mistake, you should own up to it and face the consequences. Apparently the pharmaceutical company in question, Biostratum, Inc., has yet to learn that lesson. Instead of owning up to their mistake, Biostratum tried to game the system to their advantage by asking the US Food and Drug Administration (FDA) to declare supplements containing pyridoxamine “adulterated” and effectively ban anyone but Biostratum from selling pyridoxamine.
Sadly, Biostratum’s desparate ploy to save their investment worked. Earlier this year the FDA agreed to ban companies from selling pyridoxamine as a dietary supplement. They denied the request to declare products containing pyridoxamine “adulterated,” but instead they declared that such products are not dietary supplements at all—claiming they are excluded from the definition of dietary supplements under the “prior market clause” [21 U.S.C. 321(ff)(3)(B)(ii)] and so may not be marketed as such.
Please note that nowhere in the FDA’s response letter is anything said about safety concerns. In fact, the FDA’s letter specifically says that “to allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.” Fair to the pharmaceutical companies? What about fairness to consumers, some of whom rely on affordable pyridozxamine supplements to provide the levels of vitamin B-6 required for their survival? Is it fair to force those consumers to pay for expensive prescription drugs and doctors’ visits to supply their B-6 needs when they could get the exact same thing for a fraction of the cost in the form of a supplement? Isn’t this why our health care system is so ineffective?
This is hardly the first time the FDA has attacked naturally occuring substances. On October 17, 2005, the FDA banned information about the health benefits of cherries from appearing on websites—scientifically proven benefits, such as tart cherries’ ability to reduce the risk of colon cancer because of the anthocyanins and cyanidin contained in the cherry. Cherries, according to the latest research, help ease the pain of arthritis and gout; reduce risk factors for heart disease and diabetes; help regulate the body’s natural sleep patterns, aid with jet lag, prevent memory loss, and delay the aging process; and helps lower body fat and cholesterol—risk factors associated with heart disease. Moreoever, Scientists at Johns Hopkins have found that tart cherry anthocyanins reduced painful inflammation as well as a non-steroidal anti-inflammatory drug, indomethacin.
When the 2005 ban was instituted, the FDA sent warning letters to twenty-nine companies that market cherry products. In these letters, they ordered the companies to stop publicizing scientific data about cherries. According to the FDA, when cherry companies disseminate this peer-reviewed scientific information, the cherries become “unapproved new drugs” and are subject to seizure. The FDA warned that if those involved in “cherry trafficking” continue to inform consumers about these scientific studies, criminal prosecutions would ensue.
But fresh fruit and vegetables are not the FDA’s only target: As we reported in this newsletter recently, General Mills was recently issued a warning letter by the FDA for illegally marketing Cheerios Toasted Whole Grain Oat Cereal. The problem was the claim on the cereal box that Cheerios can lower cholesterol 4% in six weeks, and the statement on their website that “diets rich in whole grain foods can reduce the risk of heart disease.” The letter, dated May 5, 2009, called the above claims “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations. FDA stated that based on the claims made, Cheerios is now an unapproved drug, and must go through FDA new drug approval process. Note that the FDA isn’t disputing the claim. It’s disputing the company’s right to make the claim.
As one newspaper columnist humorously put it, “One of these things is not like the others: morphine, penicillin, aspirin, Cheerios. Most drugs, if taken improperly, will kill the consumer or cause substantial bodily harm. An entire bottle of aspirin at one sitting will harm or kill. If Cheerios is a drug, therefore, one should be able to commit suicide by consuming the entire box.”
For years, the FDA barred health claims about the benefits of fish oil for heart, cancer, depression, body pain, and various other conditions until a drug company paid a great deal of money to go through the approval process. This type of enforcement effectively censors scientific information and greatly restricts consumer access to scientific studies that provide valuable information.
In the case of pyridoxamine, the FDA did not act out of concern for public safety. This is about money, and about a profit-seeking corporation taking advantage of what is supposed to be a public health organization in order to save their skins.