When is a dietary supplement really a drug? Often, the answer lies in evaluating the labeling of the product to see what it's intended to do. Sometimes, though, it's a drug because its key ingredient is one that's been in a drug, In a recent sequence showing that both drugs and supplements can contain the same active ingredient, a drug was marketed, then withdrawn for safety concerns, and a dietary supplement containing the same active ingredient was then withdrawn from the market, too.
In late December, the U.S. Food and Drug Administration tested a weight-loss dietary supplement and found that it contained sibutramine, which is a drug. FDA asked a company called PRock Marketing, LLC to recall the products containing it, called Fruta Planta and Reduce Weight Fruta Planta, and they did. FDA said they'd received “multiple reports of adverse events” associated with the products, including “cardiac events and one death.”
And it turns out this drug, sibutramine, isn't even marketed as a drug anymore, having been withdrawn from the market late last year. It was marketed by Abbott as “Meridia,” and Abbott asked that its approval for marketing be withdrawn, after FDA found evidence that the weight-loss product increased heart attack and stroke risks.
Ever since dietary supplements were defined as a type of food, while simultaneously being given explicit legal ability to claim medical-type effects for themselves, the line has blurred between what is a supplement and what is a drug.
Under the 1994 law that set up the legal framework, the Dietary Supplement Health and Education Act, supplement labeling can make claims about the product's effects on the body's structure or function, but, with a few exceptions, they are prohibited from claiming effects of any kind on diseases.
And the FDA has not been shy about dinging companies with Warning Letters when they think the labeling claims cross the line, that is, when a supplement product's labeling asserts the supplement can prevent, cure, mitigate or have some other effect on a disease. In those cases, FDA isn't challenging whether the substance itself can properly be a dietary supplement, rather they are only challenging what the packager is saying about the product in its labeling.
That doesn't mean FDA can't sometimes complain about what's in a supplement product, as well. First of all, the products are supposed to be made in accordance with a complex set of good manufacturing practice requirements, similar to those for foods and other types of products. Second, though new dietary supplement products don't need FDA pre-approval like new drugs do, marketers of “new dietary ingredients” within supplements must notify FDA of their plans and submit evidence establishing the safety of the ingredient.
And, in cases like this, when an active drug ingredient is an ingredient in a supplement, FDA has a few options, though it merely asked the company to stop selling the supplement due to the safety issues and the company complied. FDA would have had the legal power to halt the marketing of the supplement based on the safety concerns, but it would have been up to FDA to prove the product was unsafe. FDA also might have sought an injunction against sale of the dietary supplement product because it contained the drug ingredient, since the legal definition of dietary supplement specifically excludes articles that have been approved as new drugs.
-By Eric F. Greenberg, Attorney-at-Law
In late December, the U.S. Food and Drug Administration tested a weight-loss dietary supplement and found that it contained sibutramine, which is a drug. FDA asked a company called PRock Marketing, LLC to recall the products containing it, called Fruta Planta and Reduce Weight Fruta Planta, and they did. FDA said they'd received “multiple reports of adverse events” associated with the products, including “cardiac events and one death.”
And it turns out this drug, sibutramine, isn't even marketed as a drug anymore, having been withdrawn from the market late last year. It was marketed by Abbott as “Meridia,” and Abbott asked that its approval for marketing be withdrawn, after FDA found evidence that the weight-loss product increased heart attack and stroke risks.
Ever since dietary supplements were defined as a type of food, while simultaneously being given explicit legal ability to claim medical-type effects for themselves, the line has blurred between what is a supplement and what is a drug.
Under the 1994 law that set up the legal framework, the Dietary Supplement Health and Education Act, supplement labeling can make claims about the product's effects on the body's structure or function, but, with a few exceptions, they are prohibited from claiming effects of any kind on diseases.
And the FDA has not been shy about dinging companies with Warning Letters when they think the labeling claims cross the line, that is, when a supplement product's labeling asserts the supplement can prevent, cure, mitigate or have some other effect on a disease. In those cases, FDA isn't challenging whether the substance itself can properly be a dietary supplement, rather they are only challenging what the packager is saying about the product in its labeling.
That doesn't mean FDA can't sometimes complain about what's in a supplement product, as well. First of all, the products are supposed to be made in accordance with a complex set of good manufacturing practice requirements, similar to those for foods and other types of products. Second, though new dietary supplement products don't need FDA pre-approval like new drugs do, marketers of “new dietary ingredients” within supplements must notify FDA of their plans and submit evidence establishing the safety of the ingredient.
And, in cases like this, when an active drug ingredient is an ingredient in a supplement, FDA has a few options, though it merely asked the company to stop selling the supplement due to the safety issues and the company complied. FDA would have had the legal power to halt the marketing of the supplement based on the safety concerns, but it would have been up to FDA to prove the product was unsafe. FDA also might have sought an injunction against sale of the dietary supplement product because it contained the drug ingredient, since the legal definition of dietary supplement specifically excludes articles that have been approved as new drugs.
-By Eric F. Greenberg, Attorney-at-Law
