FDA and Dietary Supplements
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). This act permits the sale of dietary supplements without the need for FDA approval.
Prior to 1994, the FDA required herbal products to undergo the same process to be approved for sale as pharmaceutical drugs. The DSHEA changed all that by permitting supplement manufacturers to directly sell its products to consumers provided they refrained from making any claims on its label.
This law did not give the FDA the same regulatory control it had over pharmaceutical drugs but instead gave free reign to dietary supplement manufacturers. They would regulate themselves. No data was required from manufacturers regarding safety, effectiveness, or long-term toxicity of its products.
The regulation of dietary supplements is limited to its labels and advertisements. Not only are the contents barred from scrutiny and control, but even this minor regulatory power is a joint responsibility between the Food and Drug Administration and the Federal Trade Commission. As long as supplement manufacturers didn’t claim that their products could restore normal function or correct an abnormal one, the FDA and the FTC allowed them to sell anything they wanted. They were only barred from openly claiming to treat, diagnose, cure or prevent disease.
I can’t imagine the good people who still remain at the FDA are too happy about their impotence.
Dietary supplement manufacturers jumped through this loophole by claiming that their products were associated with the maintenance of good health. They also promoted unproven effects as long as they provided an accompanying disclaimer stating that the product and the advertisement was not reviewed or approved by the FDA.
A new FDA rule was put into effect in February of 2000, which clarified the definition of disease. Structure or function claims would be permitted but claims of health would not.
This fine distinction allows dietary supplement manufacturers to make claims for the treatment of hot flashes, memory problems, hair loss, joint pain, without having to prove that the products themselves are safe or effective.
The FDA is powerless against drug companies and has very limited regulatory authority with respect to dietary supplements. They are permitted under the DSHEA to simply require that certain information be provided with all dietary supplements.
This labeling requirement is similar to the nutrition panel that appears on processed foods. It includes serving size, nutrients, and other ingredients contained in the product.
It is given the attention by consumers pretty much like the insert of pharmaceutical drugs is given. None.
Since herbal supplements are not regulated as drugs, their manufacturers can market and sell botanical products, which in reality are natural drugs, without the need for FDA approval and without the expense of costly drug trials.
Dietary supplements are herbal drugs. Amateur herbologist should not able to formulate and sell these products without some kind of regulation. As it stands now, they can mix and match any plant products they like and market them as fat burning stacks, or menopausal, ocular or arthritis formulas. They are legally able to sell these products without any control over its contents.
The complete lack of control over the quality and consistency of botanical products threatens the future of herbal medicine. The USP entered the fray and began a voluntary review process that supplement manufacturers can follow to be certified as USP verified.
We need a doctor’s and patient’s bill of rights and an agency to protect those rights. Instead, we have an FDA funded by Big Pharma and the Food Industry. They depend on physician groups for advice and pharmacetucal representatives input for economic security.
Congress, through the Dietary Supplement Health and Education Act of 1994 (DSHEA) gave the dietary supplement manufacturers the responsibility to ensure that the products they manufactured were safe before it was sold.
The supplement industry was thus given the responsibility to regulate themselves and the quality of the products they sell. The FDA was relegated to fact checkers and reviewing the medicinal claims of labels.
If the purpose of establishing the FDA was to protect consumers from unhealthy foods, it has also failed. Over $65 million has been spent by the FDA to protect America’s food supply from terrorist attacks and yet the FDA allows food companies to earn huge profits by permitting the ubiquitous hydrogenation and partial hydrogenation of fats without knowing their consequences on metabolism.
How can the FDA be expected to regulate the power of PIMP when they can’t even retain their own scientists. While they are employed by the government, they are enticed to move on to more lucrative careers in PIG. Is that a reward for their work?
The FDA has failed on too many levels to be entrusted with protecting the safety of Americans. An independent board needs to be established to oversee the dismantling of the FDA and replacing it with a more independent drug safety board.
In establishing this new agency, the responsibility for drug approval must be independent from pharmaceutical interests. In the absence of an overhaul, drug safety will continue to be the subject of widespread distrust.
Congress empowered supplement manufacturers the freedom to sell virtually anything it wants. It granted them this right via the responsibilities it gave to the FDA when they established DSHEA.
Dietary supplement manufacturers are not responsible to any organization regarding the contents of their products.
Free to devote their resources elsewhere, supplement manufacturers direct monies into advertisements and marketing. The claims they place on their labels is the only component of their products that are scrutinized.
The success of their products is accomplished through marketing not science.
These products have no credibility. Pharmaceutical science rejects them because they can’t be patented. Organized medicine rejects them because it can’t prescribe them. Consumers reject them because they feel they don’t work.
Having said that, I believe in the power that true herbs possess and also know that’s not what’s being sold in healthfood and drugchain stores.
Their ineffectiveness is not due to the lack of validity of herbal medicines but rather because supplement manufacturers have no interest in the quality of the plants nor the process of extracting the plant’s vital components.