Utah, who may have the strongest supliments industry in the United Sates, will soon be hit by a new FDA ruling.
In 2005 Triangle Business Journal wrote BioStratum was in trouble because they were using Pyridorin (pyridoxamine dihydrochloride) to develop prescription drugs. Pyridoxamine is a natural component of vitamin B6 so BioStratum was unable to patent it.
Friday, October 14, 2005
DURHAM – After pumping about $100 million over 11 years into a biotech company developing a promising treatment for diabetic kidney disease, investors in BioStratum discovered the drug’s only active ingredient is sold on the Internet to anybody with a credit card.
The lack of intellectual property protection surrounding BioStratum’s drug Pyridorin is scaring away many potential partners from funding the drug’s third phase of clinical trials – typically the final tests before a drug is approved and sold commercially.
Having spent millions developing Pyridorin and other drugs in its pipeline, BioStratum does not have the capital to take the drug any further. The cash crunch has prompted investors to order a restructuring.
As stated later on in this article, BioStratum’s solution was to petition the FDA to declare pyridoxamine (a form of vitamin B6) a pharmaceutical drug, limiting access to the substance.
Intellectual property law does not allow BioStratum to own patents on pyridoxamine, but the company has a pending patent application on its method of obtaining pyridoxamine from vitamin B6.
Steiner says BioStratum officials wrote individually to companies that were selling the supplements, asking that they halt sales. The targeted companies agreed, Steiner says.
Fearful that other competitors would pop up in the future, BioStratum filed a “citizen petition” in July [2005] with the FDA seeking to disallow such sales. It claimed:
- Pyridoxamine was not sold as a drug supplement prior to the enactment of the Dietary Supplement Health and Education Act of 1994 and hence was not “grandfathered” in as a dietary supplement.
- Internet sales began after July 1999 when BioStratum submitted an “investigational new drug” filing for Pyridorin, and once a substance is part of a clinical trial it cannot be sold as a nutritional supplement, the company believes. “In our mind this is very clear,” says Steiner. “Before clinical trials, this substance was not sold … (so) in the U.S. it is illegal.”
The Triangle Business Journal claims pyridoxamine is derived from vitamin B6, where Wikipedia claims pyridoxamine is a component of vitamin B6, so some further investigation is warranted.
The Council on Responsible Nutrition submitted this fact sheet to the FDA stating:
Vitamin B6 is a water-soluble vitamin that exists in three major chemical forms: pyridoxine, pyridoxal, and pyridoxamine.
You can see all information submitted to the FDA on pyridoxamine at their web site. Notice the the FDA started calling pyridoxamine a drug before even determining whether or not it was a drug for BioStratum. The title of this docket is “2005P-0305: Remove Dietary Supplements that Contain the Drug Pyridoxamine“
http://www.fda.gov/ohrms/dockets/dockets/05p0305/05p0305.htm
At any rate, BioStratum has won this battle. They couldn’t get a patent on a substance occurring in nature, so they have managed to get the FDA to prevent companies from using it.
The whistle was blown on the FDA by The American Association of Health Freedom in an article titled When is a Vitamin Not a Vitamin? When the FDA Says So!. You can sign up for alerts from American Association of Health Freedom so you can be alerted to similar issues.
Another publication who alerted people to this issue was Natural News on February 12, 2009, although for some strange reason they did not identify BioStratum as the culprit: FDA Declares Form of Vitamin B6 a Drug, Effectively Banning Pyridoxamine from Dietary Supplements
If you would like to contact your representatives and ask them to pass laws baning the FDA from declaring natural supplements drugs, you can find their contact information at Congress.org.
Perhaps the FDA’s cozy relationship with drug companies is one reason why Congressman Ron Paul wants to eliminate the FDA.
I don’t expect to see many news reports on this issue by the mainstream media, but I hope to be proven wrong. When you watch TV who pays for more ads than anyone else? How often do you sit through a commercial break where you don’t see at least one drug company ad?
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When is a substance considered “natural” and when is it considered “not natural”? Is a “natural” supplement not a drug, and a “not natural” supplement a drug?
Is vitamin C (just about any candy, and some fruits ;o) ) a drug or a natural supplement or both? (It’s a flavoring!)
Is Resveratrol (grapes) a drug or a natural supplement or both?
Are ginkgolides (ginkgo biloba) drugs or natural supplements or both?
Is hyperforin (St. John’s Wort) a drug or a natural supplement or both?
Is tetrahydrocannabinol (cannabis) a drug or a natural supplement or both?
Are morphine and codeine (poppy) drugs or natural supplements or both?
Do you draw a line somewhere? If so, what criteria do you use to determine which side of your line a chemical is on? Maybe you determine based on whether the chemical is a vitamin or not?
Or do you not draw a line?
I believe the biggest issue in this particular case is pyridoxamine was declared a drug by the FDA because they were looking out for the financial interest of a drug company.
People have the illusion the FDA is here to protect people, but their loyalty is to the drug companies who happen to staff their advisory board.
It would be interesting to see how many “gifts” pass over as well.
Personally I believe I should have the right to read up on a product and determine whether or not I should take it. I am an adult so I can read the pros vs. the cons and then make my own decisions. It’s my body.
Are the people of the United States going to let the FDA dictate what supplements they can and can’t take on behalf of drug companies?
The only things that bothers me are the “Proprietary Blend” BS so you can’t tell what’s actually in a product, and where the ingredients come from.
It could be corn starch for all we know. That’s the only thing I think needs to be reformed. As citizens, we can boycott products that use this type of deceptive labeling.
I would like to see a web page for each product that lists what country the ingredients come from, so we could try to avoid ingredients from China for example, or if there was a tainted ingredient on the market, you could see if the product you’re using was likely contaminated.
So, you are in favor of allowing people to take drugs that are currently illegal, or legal only with prescription, such as heroin and methamphetamines?
Also, do you have a link to the actual FDA ruling (if that is the correct term)?
As an integral part of vitamin B6,pyridoxamine has been taken as a supplement for as long as the B6 it was a component of. The body no doubt cleaved this faction as needed.
This is a very disturbing president and one that needs to be stopped before it snowballs.
I called the FDA at 1-301-796-3400 and they said they were not sure if a ruling had been made on Pyridoxamine or not. They are checking on this for me.
They did say BioStratum first listed they were using Pyridoxamine in investigational drugs back in 1999, so it is only fair to protect the financial investment of the drug company, even if Pyridoxamine occurs naturally–meaning it’s not a synthetic drug.
Whatever the actual outcome is, I know for sure that Pyridoxamine is still being sold openly on the internet by reputable vitamin companies. I know that there is now a prescription-based fish oil product that is used by hospitals since they prefer overpriced prescription products to quality OTC products. BioStratum need not be greedy; they will make plenty of money through the normal hospital/physician channels, and the informed consumer will find it on the shelf and purchase it that way. I guess it’s a win-win for everyone as long as the FDA stays out it.
The mindset prevalent at the FDA is revealed by the following:
They refer to the general public as “the laity”.
In case you’re unfamiliar with the term, it is religious. There is the “clergy”,
and there is everyone else — the “laity”.
FDA thinks of themselves as high priests of medicine!
The more you know about the stuff they’ve pulled over the years, the more this mindset explains nearly everything.
What’s that percentage of health care costs that are incurred in the last days and hours of life risen to now?
Thank you for your help!.
Big money can apparently hijack control of any substance with the help of their buddies in the FDA. We need to call this for what it is: treachery against the American public by Biostratum as a whole, the company’s administrators and lobbyists. The people of a nation that allow legalized bribery of public officials will be nothing more than cattle to those with money and power. Take a good look at the “contributions” given to our politicians by drug companies and other special interests.
Despite the devastation of the sick drug war, some lines should be drawn. Anyone who compares b-6 to amphetamines or codeine is either stupid or stands to profit from such a declaration. Last I checked, amphetamines and opiates are not vital nutrients and are not present in the foods we eat. No one microwaves their baby after staying up for 10 days on b-6 getting high. I seriously doubt very many people rob and kill to support their vitamin habits.
I grew up the 1960s, the kind of kid that read content labels, such as they had them, on items for sale in the pharmacy and grocery store. Some multivitamin bottles’ labels, back then, clearly stated after the vitamin B6 in parentheses, (pyridoxine, pyridoxal, pyridoxamine). This was a quarter century plus before 1994 and DSHEA.
I think the lawyers and/or management for Biostratum and the FDA must be unusually uninformed or liars and frauds. We need penal oversight of the FDA, perhaps like the Chinese, who even executed their top FDA official for corruption that involved dozens of innocents deaths.