Adderall Knockoffs Are Unapproved, Potentially Dangerous, Experts Say

Jan. 30, 2013— -- Students hoping to bolster their grades may want to study the ingredients of some new products being marketed as prescription-strength study aides.

Two companies, Gentech Pharmaceuticals and NexGen Biolabs, are engineering products touted as alternatives to Adderall, a prescription drug used to help improve focus in patients diagnosed with attention deficit hyperactivity disorder.

While the websites for these Adderall alternatives say there is no prescription needed, they also say their supplements include synthetic amphetamines, the active ingredient in Adderall.

"Some of the chemicals we're talking about are only in prescribed medicines," said Dr. Philip Cole, director of pharmacology and molecular sciences at Johns Hopkins University in Baltimore. "The notion that they're also in dietary supplements is a significant concern."

But Dr. Stan Headley, the medical director at Gentech Pharmaceuticals, said it's difficult to make a direct comparison betwen the active ingredient in his company's Adderall-like pill, called "ADDTabz," and the amphetamines found in Adderall.

Headley said companies like Gentech take the ingredients in popular drugs and reformulate the compounds to create a very similar product.

"It's a unique niche that we have," he said. "Our product is stronger than something you would find at a health food store, but yet not as potent, not as strong as prescriptions."

Nexgen did not respond to an ABC News request for comment.

Although they may be more potent than a product you could find in a store that sells vitamins, these Adderall knockoffs are listed as dietary supplements, which are not regulated by the U.S. Food and Drug Administration as are prescription drugs.

Under the Dietary Supplement Health and Education Act of 1994, companies that manufacture dietary supplements do not need FDA approval to sell their products. The law also states that the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.

However, according to the FDA, there is no provision under any law that requires a company to share the information they have about the safety of their dietary supplements with the FDA. The only time a company needs to disclose information regarding the safety of their supplement is if it contains an ingredient engineered after 1994.

Companies using new ingredients are required to file a New Dietary Ingredient Notification, which requires that the manufacturer demonstrate to the FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement.

Neither Gentech nor Nexgen submitted a New Dietary Ingredient Notification with the FDA for their amphetamine-like compounds, according to an FDA spokesperson. Neither company responded to an ABC News request for a comment on the missing paperwork.

The FDA, though, can do little to stop the sale of unapproved products. If it deems an ingredient unsafe, it can send a warning letter to companies asking that they stop manufacturing a product. But checking the ingredients of the countless supplements available online and in stores is a daunting task for the administration, which leads to new, unapproved ingredients hitting the market.

"Legislation in 1994 codified the principle that if you are nutritional supplement, you have a much lower burden of being regulated," Cole said. "Many things marketed as nutraceuticals -- with no scientific basis in therapy -- are purchased and consumed."