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."

Supplements Touted as Prescription-Strength Study Aids

The reformulated, Adderall-like pills are also advertised on college campuses across the country. ADDTabz, made by Gentech Pharmaceuticals, went on a marketing blitz last fall, which led to campus coverage from the University of Central Florida to Ohio State University.

Harvard's student newspaper, The Harvard Crimson, got flack last September for running an advertisement for ADDTabz in their student-run publication.

Another Adderall knock-off, AdderRx, made by NexGen Pharmaceuticals, had brand representatives hand out free samples of the pills at 10 universities, including the University of Florida, Penn State University and Arizona State University.

Anthony Sirianni, a 21-year-old senior at the University of Florida, said one of his friends received several free samples of AdderRx on campus and gave him a pill. He took the bright orange tablet after waking up exhausted before a road trip.

He said he felt fine as he started driving but developed symtoms over time.

"My heart was beating really fast. I felt hot, and I sweated a lot even though I wasn't outside," Sirianni said. "It was like jitteriness, uneasiness, and I felt worried for no reason. I didn't know what was wrong; I didn't want to interact with people. I just wanted to sit and ride it out."

Sirianni has not been diagnosed with ADHD, which may be why he experienced apparent side effects, according to Dr. Rachel Klein, a professor of child and adolescent psychiatry at New York University.

Klein said when Adderall or amphetamine-containing substances are given therapeutically to those with ADHD, those patients often experience a subtle decrease in energy that can help them perform day-to-day tasks.

"They'll exhibit more appropriate behavior, be less impulsive, less impatient, less hyperactive," Klein said. "It doesn't do this to people who don't have ADHD. You won't feel lethargic if you take it -- if anything you'll feel more stimulated."

That stimulation sensation can lead to the faster heart rate and uneasiness Sirianni experienced, but Klein said long term use of Adderall-like stimulants by those who don't have ADHD could lead to more serious psychological side effects.

She said these effects hinge on how much you take and how often you take prescription-grade amphetamines, and if you have an underlying psychological issue you may not be aware of.

"If you keep taking it at high doses, you can develop psychotic symptoms," Klein said. "These could include being suspicious of everyone, thinking things around you have special significance. You feel like you're in some sort of danger, or delusional like people are against you and want to hurt you."

But Headley with Gentech Pharmaceuticals said his company reformulated the ingredients found in Adderall to try to eliminate most of these side effects.

"We're sort of playing off of [Adderall's ingredients] for something that is safer and cleaner without the side effects," Headley said.

The amphetamine-like substance in ADDTabz, called Ampheta CDP, can't be found in medical literature or in Google searches, mainly because Gentech invented the compound. AdderRx uses a compound called Nuphetamine HCM, another ingredient that can't be found in medical resources or internet searches. The only information the company said about the ingredient in AdderRx is that it has "a chemical structure similar to the naturally occurring adrenaline and noradrenaline."

Pills Lack Safety Data

Johns Hopkins' Cole said the descriptions and names of the ingredients signal to him that the compounds are extremely similar to amphetamines, which promote the release of the hormone adrenaline known for its role in the "fight-or-flight" response.

"Amphetamines are dangerous, potentially very toxic stuff," Cole said. "It could cause cardiovascular toxicity and dilate blood vessels, which could lower your blood pressure and cause changes in heart rate that could be dangerous."

But Headley said the compound his company uses lacks these dangerous side effects because it's not identical to the amphetamines used in Adderall.

"It comes very close, but it's not the same chemical, and it's not the same ingredient," Headley said. "It's not like comparing apples and apples -- it's more like oranges and tangerines."

Since ADDTabz launched last year, Headley said he's only heard mild complaints from 1 to 2 percent of people who have tried the product.

Still, Cole advises consumers to steer clear of products labeled as "prescription strength" containing synthetic amphetamines or ambiguous ingredients.

"These should be treated the way prescription drugs are treated and prescribed by a physician if they are given," Cole said. "And I'm not saying they should be given at all."