Earlier this year, we told you about an FDA back-channel that allows drug companies to turn supplements into drugs—and remove the supplement versions from the market. This has happened to a popular and medically important version of vitamin B6 (pyridoxamine), and with the FDA’s approval of a new drug to treat sickle cell anemia, the same could happen to L-glutamine. Unless we close a back-channel at the FDA, more and more supplements will be turned into expensive drugs, and consumers won’t be able to manage their health cheaply and naturally with the supplement versions.
Last year, the FDA announced the approval of Endari, a drug for sickle cell disease. Endari is an oral powder comprised of L-glutamine, an important amino acid currently available as a supplement. The drug company, Emmaus Medical, Inc., filed an investigational new drug (IND) application—demonstrating their investigation of L-glutamine as a drug—on May 15, 1997. This is important because there is no new dietary ingredient (NDI) notification for L-glutamine. (Think of an NDI notification as a “new supplement” notification; by law an NDI notification must be filed on supplements that came to market after 1994.)
Enter the FDA back-channel. If a drug company begins investigating a nutrient for use in a drug before a supplement company files an NDI notification on that nutrient, the company can ask the FDA to have supplement version removed from the market, leaving consumers with no other option than the drug. Currently, a 120-pill bottle of L-glutamine can be purchased for less than $10; a year’s worth of Endari will reportedly cost consumers more than $40,000.
If Emmaus enforces its IND, the only way that L-glutamine supplements could survive is if the FDA decides that L-glutamine was in the market “in or as” a supplement before 1994. To make matters worse, the FDA has not completed its policy that lets companies know what is and isn’t grandfathered, or even how to file an NDI notification. Given how the current draft of the FDA’s proposal is written, there’s even a real danger that supplements most people would think of as “grandfathered” could require NDI notifications. All of this creates confusion that only helps drug companies further exploit this back-channel.
CBD oil faces a similar threat. For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year. While the FDA has not removed CBD oil supplements from the market yet, FDA’s declaration indicates it may be only a matter of time.
Until we close down the IND back channel that allows Big Pharma to turn supplements into drugs, we will continue to see this happen. There’s too much money to be made. That’s why ANH is advocating for a legislative change that will protect natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market in a dietary supplement. These rules should apply retroactively to protect CBD oil, pyridoxamine, L-glutamine, and other substances that have already (or are likely to be) removed before this legislation becomes law.
Action Alert! Write to Congress and urge them to close the FDA back-channel that turns nutrients into expensive drugs.
For USA - CVS Pharmacy to Stop Selling Xtandi and other Cancer Drugs
For Patients in USA - Drug Prices Are Outrageous, but There Is a Way to Reduce Them - from MedPage Today
