Patenting Nature? FDA in Bed with Big Pharma Over Vitamin B6...

by mgmirkin | February 23, 2009 at 12:12 pm

822 views | 99 Recommendations | 14 comments

Recently, it was brought to light that FDA Scientists are Revolting (against upper management, that is). Perhaps now it's time for a more general uprising against the FDA. When is enough too much already? It seems they're siding with Big Pharma against nature and the marketers of dietary supplements including vitamin B6 (pyridoxamine).

It seems that a company called BioStratum has recently made public research on a "new drug" based upon a vitamin B6 derivative, and has apparently turned the ear of the FDA to their cause (making the compound a protected "drug" and limiting dietary supplement manufacturers from continuing to include it in their lineup).

The Food and Drug Administration (FDA) has ruled that the vitamin B6 compound, pyridoxamine dihydrochloride, cannot be used in dietary supplements.

The decision, in response to a petition from a North Carolina-based firm called Biostratum, provoked the Washington DC-based Council for Responsible Nutrition (CRN) to issue a statement warning that a precedent could be established that could see the status of other ingredients challenged.

The problem is that under FDA rules, apparently compounds considered to be "new drugs" cannot be sold as ingredients in nutritional supplements, or something to that effect. There is however a grandfathering clause wherein it says that if such an ingredient has already been marketed in food, it is "grandfathered in" and not subject to exclusion from ingredient lists.

In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and “may not be marketed as such.” Although pyridoxamine is a dietary ingredient within the meaning of § 201(ff)(1), FDA determined that pyridoxamine is excluded under § 201(ff)(3) because: (1) pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public; and (2) there is no “independent, verifiable evidence” of prior marketing of pyridoxamine as a food or dietary supplement.

Grandfathered?
There exists a grandfathering clause for ingredients that have been on the market for more than 15 years, but CRN said the way this list functioned “was not agreed upon”.

This 15-year period coincides with the enactment of the 1994 Dietary Supplements and Health Education Act (DSHEA), around which time much evidence was presented supporting ingredients such as pyridoxamine dihydrochloride.

“We are disappointed with FDA’s response to the recent citizen petition involving pyridoxamine that apparently views as inadequate the evidence presented by the industry, including CRN, of the previous marketing of pyridoxamine, even prior to the passage of DSHEA,” said CRN vice president of scientific and regulatory affairs, Andrew Shao PhD.

“FDA’s decision suggests that companies need to produce even more extensive evidence supporting an ingredient’s marketing as a dietary supplement, including catalog and business records from more than 15 years ago.”

The question seems to come down to two things. 1) is this compound something that's been around for a long time and specifically marketed in food and/or dietary supplements, thus making it "grandfathered in" and legal to continue selling, as such? 2) Should the FDA let Big Pharma "patent" nature, and remove the right for manufacturers of dietary supplements to include said compounds in their products?

Such a precedent appears to be rather dangerous... Can Big Pharma "patent" natural molecules, call them "drugs" and get the FDA to ban them, except as "drugs" marketed by Big Pharma? What's next? Outlaw blueberries, pomegranates and acai berry products, because Big Pharma wants a lock on antioxidants as "drugs"? Ban oatmeal, Cheerios and garlic because they have cholesterol-lowering health benefits that Big Pharma wants to luck up in their "drugs" for a profit? Where does the line get drawn?

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Terri Potratz

at 12:46 on February 23rd, 2009

Scary stuff - thanks for this story.

Roy C

at 13:18 on February 23rd, 2009

Yeah, this is the way it operates. I will do a story on how Pearson and Shaw had to fight the FDA to let folic acid suppliers use valid research to make a claim about the pills. The FDA lost and was told to allow the claim that folic acid pills prevent birth defects.

Wouldn't you know that the FDA refused to honor the legal judgment and Pearson and Shaw and an army of lawyers went back and won second round where a judgment was rendered that FORCED the FDA to allow the labeling statement.

mgmirkin

at 14:50 on February 23rd, 2009

Interesting... More wonderful news from Big Government! ;)

Regards,
~Michael

Gemfinder

at 18:14 on February 23rd, 2009

Very interesting article. Something serious has to be done about those infants getting non Big Pharma B vitamins from breast milk.

Invisibili

at 18:28 on February 23rd, 2009

A little box of VC

Invisibili has contributed a photo to this story.

Paschen

at 19:51 on February 23rd, 2009

Most interesting. Money seems to be the source of all ivil, at least here.

Barry Artiste

at 20:23 on February 23rd, 2009

Nothing beats the real thing, supplements just are not absorbed by the body as readily as fruits and veggies. Thats My opinion anyways!

duo

at 21:05 on February 23rd, 2009

The grandfather clause makes sense and seems fair. I do not see how they could make it illegal for these companies that have been selling B6 for many years - decades! - and have them stop selling it simply because some drug company decided to use it, too. I have read that if authorities had known years ago all the things that asprin is good for, it would have never been released across the counter, but would have been an expensive prescription drug. If this highjacking works with B6, I suppose next someone will create a drug and use asprin as an ingredient, then there goes that! Then comes your rubbing alcohol! Oops! Yonder went Vitimin C! Will someone call the doctor to renew my prescription for vasaline, please?

Amy Judd

at 21:22 on February 23rd, 2009

I just get so concerned that you just never know what you are putting into your bodies with anything anymore. Thanks for this piece.

Smile

at 22:28 on February 23rd, 2009

No one - I repeat no one - should be allowed to have a monopaly over a natural occuring vitamins or minerals. BioStratum should not have been permitted to have such exclusive rights to B6. This is no differant from making air a protected DRUG because they are using a derivative from the atmosphere. I'm so disgusted at this news.

Maireid Sullivan

at 01:20 on February 24th, 2009

Good post, Michael, thanks.

The FDA is now part of THE problem, because their executives move from corporate to government sectors at will.

Just finished dinner - a bottle of good wine for two, and a tiny bit of meat, with two raw salads, all organic / BioDynamic –coleslaw and lettuce based, including at least a dozen raw ingredients in each.

Thats how to keep your body chemistry pH alkaline -because its been proven that cancer and arthritis can't develop in alkaline pH body chemistry.

Of course, you can use acidophilus too. VERY good! But in an emergency stress situation, you can just take a tea-spoon of old-fashioned bi-carb soda, in a little water, to convert acid to alkaline pH in an instant. Good before bed (for 'pleasant' dreams) and first thing in the morning, during stressful times.

RoryKearney

at 11:15 on February 24th, 2009

The FDA is a corrupt, selfserving organization. They care not at all for the health of the nation. They get rich while we die.

mgmirkin

at 11:17 on February 24th, 2009

Isn't their mandate to safeguard consumers, and not necessarily to cater to big pharma? Have they abdicated some small part of their mandate with recent events (noted in this and the prior article)?

~Michael