The FDA, as the catspaw for the pharmaceutical industry has a long history of trying to stop or limit the use of supplements which they perceive as potential competition for prescribed medication. From their point of view, they would like to wrap the whole natural industry in red tape, increasing the costs so that they can no longer survive economically. They never gave up even after Congress and the Senate blocked them on past occasions.
If you feel that having access to supplements is important for your health and you would not like to see them become more expensive or dissapear altogether, you need to protect your access by exercising your democratic rights. This newsletter will explain what's going on and what you can do.
The landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) required that guidelines be established for supplement manufacturers to notify FDA when a new dietary ingredient was introduced into the marketplace. The FDA’s Draft Guidance for New Dietary Ingredients was supposed to fulfill that requirement.
The FDA are now trying to subvert the intention of Congress by issuing totally unreasonable NDI draft guidelines that threatens so many supplements. They are currently refusing to listen to Congress or follow the intent of the law.
Senators Orrin Hatch and Tom Harkin met with Dr. Daniel Fabricant of the FDA on January 26 to request that the FDA withdraw its NDI draft guidance altogether. They were following up on their recent letter to FDA Commissioner Margaret Hamburg asking the FDA to stop the process altogether, withdraw the guidance, and start again after meeting with interested parties to address the list of significant concerns expressed by consumers and industry.
Unfortunately, the FDA’s proposed regulations are in fact completely contrary to the intent of Congress when DSHEA was passed, and Sens. Harkin and Hatch wanted to make that clear to FDA. They should know—they were the two principal authors of the legislation!
I have heard that the FDA has turned down the senators’ request. FDA in effect said that it is refusing to reconsider its interpretation of what the NDI section of DSHEA means, regardless of what Sens. Hatch and Harkin say they meant when they wrote the law.
Does this mean FDA intends to use the NDI process as a de facto pre-market approval system—something which regulatory observers believe was specifically excluded by DSHEA? In a word, yes.
We have been told that FDA claims the NDI process is the only “preventive control” for dietary supplements in federal law. Whatever “preventive control” means, it is completely untrue that supplements are uncontrolled under federal law or that the FDA lacks the power presently to regulate them.
In refusing to follow the intent of the law as clearly stated by the law’s authors, the FDA is acting as a rogue agency.
If the FDA’s plan were to go forward, it would sweep many supplements off the shelf and make the ones that survive much more expensive. We need to make the Draft Guidance such a hot-button political issue that FDA will be forced to take notice and will address the public’s serious concerns.
Please write to Congress and ask your senators and representative to make a one-minute speech opposing the guidance.
Example below of such a request (please personalise):
I was thrilled to see that several members of Congress have taken a strong stand against the FDA's draft guidance on New Dietary Ingredient notifications for dietary supplements. This disastrous document turns what was meant to be a simple notification system into a scheme where FDA can approve -- or deny -- any supplement created in the past eighteen years, making the FDA the ultimate arbiter of what dietary supplements will and will not be available. This is completely contrary to congressional intent when DSHEA was enacted eighteen years ago.
Worse, it would sweep many nutritional supplements off the market, losing over $1 billion in revenue, and forcing over 100,000 Americans to lose their jobs. and make the ones that survive much more expensive. The federal government will lose between $1.84 billion to $3.54 billion in federal tax revenues; state and local governments will lose between $1.64 billion and $3.07 billion in taxes.
Rep. Randy Hultgren recently made a one-minute speech on the floor of the House urging the FDA to "go back to the drawing board" so that the NDI Draft Guidance doesn't limit Americans' access to dietary supplements. Sens. Tom Harkin and Orrin Hatch wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document.
I am writing today to ask you to join your colleagues and make a one-minute speech opposing the NDI draft guidance. Ask FDA to retract its guidance and start over. We need guidelines that do not impose unreasonable barriers that limit or slow the flow of safe products and accurate information to consumers. Please uphold the landmark legislation Congress passed eighteen years ago!
Ben Ong
bensprostate.com