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.”
So the battle over rutin seems to have been joined. We will keep you posted on what happens next.
Meanwhile, let’s not forget that we have already lost very important supplements in this way. Remember the drug company that successfully petitioned FDA to apply section 201 and remove pyridoxamine from the market? You may also recall that another pharmaceutical company is trying to do the same thing with P5P (pyridoxal phosphate), the only natural and bioavailable form of vitamin B6.
If you haven’t already done so, please help fight the P5P takeover with our Action Alert! The FDA is playing a waiting game, not responding to the P5P drug petition, yet hoping that public interest will subside. We need to let them know that public opposition to this kind of theft of supplements by drug companies is not going to go away. Please take action now!
Does this #301 part mean that they could even confiscate all our apples and not let us buy apples because of rutin? Sometimes I think the FDA and that other entity arm (can’t remember all those capital letters) should be harnessed and defrocked and just be totally revamped into an actually helpful tool rather than a scapegoat of the big pharma. This information is totally disgusting to me.
Another example of corporate greed trumps all. If the cabal of FDA and Big Pharma succeeds, it will be guilty of murder as soon as the first corporately unprotected victim dies. Congress must step in and pass laws to end this dangerous criminal activity.
We need to talk to our representatives and tell them to pass legislation that drug and pharmaceutical companies be banned from patenting ANYTHING that can be found in the natural world , even if they choose to use it or concentrate it . NATURAL FOOD AND SUPPLEMENTS SHOULD BE TREATED AS PUBLIC PROPERTY , FOREVER .
Big Pharma already took a simple fish oil supplement and turned it into a prescription drug.
Another example of how the drug companies in cooperation with the government is trying to control our lives. How can the drug companies be allowed to produce a drug that mimics the health benefits of real food which has no dangerous side affects unlike prescription and non prescription drugs which all have dangerous and many times life threatening side affects. With over 120,000 people dying the use of prescription and non-prescription drugs each year, how can the FDA morally allow the drug companies to have this much control. It’s all about the profits with little if any regards to public health. Being rated 26 in the world health wise, the US is not a healthy country as a result in great part to the drastically over prescribed and over use of prescription and non prescription drugs and vaccinations.
Ok, I’m a liberal but reading this makes me want to reconsider Ayn Rand. Talk about over regulation.
I am counting on you to prevent the drug companies from taking over a natural supplement, derived from Apples called rutiin – also part of some other foods. The drug companies are seeking to make a very expensive drug out of this, and seeking to ban the inexpensive, natural form! Please prevent this. It has already happened to at least one other supplement.
My question is, what makes anyone think that our complaints will sway congresspeople to sway FDA? FDA has been ignoring Congresspeople’s pleadings for the last several years. The only reason FDA recently listened to Orrin Hatch’s demands that FDA back off, is that Orrin Hatch holds part of FDA’s purse strings. Even then FDA did not back off. FDA merely offered a six-months’ extension before it implements its self-created “guidelines”. Why six months? Hm. Maybe because that is how long FDA’s pet pharmaceuticals can extend their currently expiring patents. Until then, those drugs don’t need FDA protection.
And–why would FDA also self-decide not to accept any research after 1994? Hm. Maybe because, according to documentaries and articles, the drug industry has not done any groundbreaking new research since 1994–everything has been just variations on pre-existing research.
By contrast, nearly all the groundbreaking research in the natural health and supplements industries has been performed _After_ 1994. So–FDA wants to ban all research after 1994. Bad for supplements, good for Pharma.
Hm. I can spell corruption. I can even smell corruption. But I do not know how to effectively stop corruption in government or government agencies.
Emailing and phoning my congresspeople did nothing to stop anything, from my experience. Only one congressperson responded at all, and then only by an emailed form letter whose sole firm assertion was that “supplements must be supervised.” I got no response at all from anyone else. So I phoned another one. I got the office answering lady–who did not know which committee had oversight over FDA, or how to find out, or how to contact them. She suggested one committee–and gave me the URL–but it turned out to be the wrong committee, and the committee’s website provided no contact data at all–no phone number, postal address, or email address. No names of committee members, even.
Further–at this time, who are you going to contact? Nobody’s at work now. Congress has recessed early and will not return until after November elections. Who would we contact–given this is an election year and we have no idea who will be our representatives after November elections. And when would anyone be likely to read whatever we emailed to them, given that Congress is not in session? And after Congress reconvenes–how much attention are they likely to pay to FDA’s acts designed to create a drug monopoly against…
We all know that this is just another “follow the money” game being played by big pharma. This is not just marketplace competition, which would be ok. This is using our tax dollars (FDA being a government agency) to keep from us safe, effective, natural, affordable supplements for the sake of one industry making more profit.
Leave our supplements alone.
Capitalism without government interference = healthy economic growth (and healthy people). Capitalism with government interference = big pharma wins, we all lose.
But I swear I still have access to P5P. Has this ban been lifted?
As long as I can I will eat the apple — screw the FDA and the federal government
Have a good source to organic apples
This article says “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!).” In the case of rutin, there is no problem showiung sales before 1994. A quick look at some old catalogs shows the following:
Puritan’s Pride Catalog 251 sale enmds Sep 16, 1993: Product 753 Rutin tablet 50 mg
Vitamin Coop spring 1994:
K AL 4-17-980, 4-17-006 Rutin tablets 250 mg
SOLGAR 3-75-189, 3-75-106 Rutin 500 mg
Bio Energy Nutrients order before Dec 8, 1992: SU60R Super C –listed ingredients include rutin
Natrue Food Gentres received June 1977: Poten-Cee 300 mg vitaminC with 12 mg rutin
Nutrition Headquarters Post mark Feb 1977:
Special C-500 includes 50 mg rutin
High Bioflavites includes 50 mg rutin
Complete Formula #1 includes 30 mg rutin
L&H vitamins (c)1979: Flavanoid C complex includes 25 mg rutin
Health Savings Center (estimated 1977) H2X on order form: Rutin tablets 50 mg
There is actually a history of pharmaceutical companies working to create a foundation for the development and sale of flavonoid materials under the current DSHEA reglations. An example of this is the 2000 GRAS application to FDA by Merck Germany for approval of isoquercetin (a flavonoid metabolite of rutin and quercetin).
FDA reviewed the dossier and was ultimately satisfied with the safety documentation and research supporting intended use. The documents submitted by the GRAS committee were allowed to stand unchallenged and this flavonoid was cleared for sale in the USA as long as the material is offered for sale in a manner consistent with the GRAS submission reviewed by FDA and the provisions of DSHEA regulations.
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