Dietary Supplements: Why the FDA Doesn't Have To Approve Them
Mike Bloom, Dan Blair and Paul Bousche'
Issue date: 3/24/09 Section: News
While the two are very similar, by law, a product sold as a dietary supplement and promoted on its label as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved and illegal drug. Supplements never claim to cure anything - instead they are supposed to be used as an effective enhancement to an ordinary diet, yet that is not always the case.
According to FDA.gov, supplment manufacturers not have to register their proucts with the FDA and just have to ensure that the label is truthful and not misleading. Therefore, a product can be released on the market without any type of government testing or approval..
the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer," said the FDA.
Nor does the agency take responsibility if a product has been reportered while it is on the market.
"Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products," said the FDA.
Under the Dietary Supplement Health and Education Act of 1994, signed by the Clinton administration, these products were able to be marketed before being tested. Under the current structure, once the product is marketed, the FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace.
clinical Testing
In the 1960s a drug named AZT was being studied as an anti-cancer drug with disappointing results. However, as a result of the data compiled through testing, it was found that the drug could treat the deadly disease of AIDS.
According to FDA.gov, supplment manufacturers not have to register their proucts with the FDA and just have to ensure that the label is truthful and not misleading. Therefore, a product can be released on the market without any type of government testing or approval..
the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer," said the FDA.
Nor does the agency take responsibility if a product has been reportered while it is on the market.
"Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products," said the FDA.
Under the Dietary Supplement Health and Education Act of 1994, signed by the Clinton administration, these products were able to be marketed before being tested. Under the current structure, once the product is marketed, the FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace.
clinical Testing
In the 1960s a drug named AZT was being studied as an anti-cancer drug with disappointing results. However, as a result of the data compiled through testing, it was found that the drug could treat the deadly disease of AIDS.
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