Will another supplement be turned into a drug?
Harvard researchers have found that a flavonoid compound in apples called rutin (it’s also found in onions, buckwheat, citrus fruits, and tea) has powerful properties that prevents blood clots in heart vessels. Rutin could prevent both the arterial clots that cause heart attacks and strokes and the venous clots that cause deep-vein thrombosis and pulmonary embolism. So it works far better than existing anticlotting drugs, which only prevent clots in one or the other, and is much safer. This is getting the drug industry very interested.
Rutin is already sold as a nutritional supplement. But now that conventional medicine is investigating it, will rutin be modified and patented as an FDA-approved drug? If that happens, will it be banned as a supplement, and be available only as a $100-per-pill medication?
What rules would apply to rutin? The language of current laws is often dense and confusing, and two conflicting provisions put supplements like rutin at risk.
The US Federal Food, Drug, and Cosmetic Act (FD&C) is a set of laws passed by Congress in 1938 giving authority to the FDA to oversee the safety of food, drugs, and cosmetics. It has been added to and amended many times over the years, but it remains the rulebook for everything FDA is empowered to do. The two conflicting provisions in the FD&C are section 201, which applies to supplements, and section 301, which applies to food.
Section 201(ff)(3)(B)(ii) states that the term “dietary supplement” does not include anything that is being studied as a possible drug, that is, authorized by the FDA for an Investigational New Drug (IND) review—provided that substantial clinical investigations have been instituted and the investigations have been published. There is an exception, however. This doesn’t apply if the substance was first legally marketed as a dietary supplement or a food.
But—and this is a big but—in order for the supplement to be considered legally marketed, the ingredient either had to have gone through the FDA’s NDI (new supplement) notification process, or have been sold before 1994 (which may be difficult to prove!). As most of our readers by now know, the odds of getting an NDI notification accepted by the FDA are extremely low—low enough that many supplement manufacturers don’t even try.
So here we have another FDA Catch-22. According to 201, drug companies can’t steal a supplement and get sole use of it as a drug if the supplement has previously been sold according to FDA rules. But the FDA sees to it that most newer supplements won’t qualify for this protection.
If what we have told you so far about the law governing a supplement like rutin sounds complicated, it is. But it gets even more complicated because of another section of the law called 301 and what the FDA is saying about it.
Section 301(ll) prohibits the interstate sale of any food that contains, in whole or in part, a legal drug or biological product. There is an exception here too. Such a food may be sold if it was available before any significant research has been done on it and published and before approval of the drug.
Let’s be clear what this means. If even one study on the therapeutic effects of the food has been published, drug companies can claim the underlying substance is a drug. Section 301 also says that a drug company need not file an IND (Investigational New Drug) application before trying to turn a food or supplement into a drug.
If 301 were to apply to supplements, this would make it even easier for pharmaceutical companies to claim ownership of a supplement and the right to turn it into a drug. There are innumerable natural products for which clinical research on their therapeutic effects has been published; this would be enough to turn those natural ingredients into drugs and therefore make it unlawful to market them as supplements.
It’s just yet another Catch-22. On the one hand, FDA seems to say that scientific research on supplements is inadequate, so that nobody should use them. On the other hand, if any research has been done on them, they automatically become drugs anyway. Heads the drug industry wins; tails it wins too.
In 2008 FDA asked for public comment regarding the interpretation of 301, and ANH-USA submitted formal comments. FDA has never responded or provided clarification on how they interpret section 301. Are dietary supplements considered food for the purpose of section 301? If so, which takes precedence—section 201 or 301? Why should 301 apply to supplements at all, since section 201 was created specifically to address them?
In the NDI (new supplement) draft guidance that the FDA recently issued, and is now revising, the agency explicitly states that it has not reached a decision on whether section 301 applies to supplements (see question 6). Not only that, they are reserving the right to retroactively implement section 301 with respect to supplements. This means that even if supplement companies have gone through the expense of submitting NDI notifications under section 201 and have been marketing their products, they are still not safe from losing their product at some later stage to Big Pharma, which will patent them to ensure market exclusivity.
The lead researcher for the rutin study said, “These preclinical trials provide proof-of-principle that PDI is an important therapeutic target for anti-thrombotic therapy, and because the FDA has already established that rutin is safe, we are poised to expeditiously test this idea in a clinical trial, without the time and expense required to establish the safety of a new drug.”