Smart Drugs and Drink May Not Be Smart : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Despite these known side effects, the "smart" drink faithful insist there is no danger.

"I don't believe the drinks have anything in them that will give me Alzheimer's when I'm 50," said Michelle Barnett, a 28-year-old San Francisco marketing specialist who has been consuming "smart" drinks for a year and a half. "The traffic outside my window is worse. The water is bad, and our food chain is bad. I think that if I drink amino acids it's positive, not negative."

McGaugh disagrees. "You can view these things as mind toys," McGaugh said. "People have responded to unsubstantiated claims."

The Rise in "Smart" Drug Use

"Smart" drugs began to gain popularity in the early '80s, when baby boomers in their 30s and 40s started using them as a way to improve job performance and gain an edge in the workplace.

There is no way to accurately calculate the number of people using "smart" drugs today, but Ward Dean, M.D., coauthor of Smart Drugs and Nutrients, the guide for users, estimated that the number is close to 100,000. "Smart" drink users, Dean said, number about 10,000, with many occasionally using "smart" drugs.

Another group of "smart" drug users is made up of healthy elderly persons who, even though they may not have age-associated memory impairment, feel they aren't as mentally sharp as they used to be, Dean said.

People with documented intellect impairments caused by Alzheimer's disease and stroke form the smallest population of "smart" drug users.

According to Dean, "smart" drugs cost about 85 cents a day to use. "Smart" drinks, served mostly in trendy California and New York bars, cost about $3 each.

Are "Smart" Drinks and Drugs Legal?

Because "smart" drinks are made with amino acids, which FDA regulates as foods, they are legal as long as they're not labeled with health claims. Under the Federal Food, Drug, and Cosmetic Act, any product that makes medical claims is considered a drug and must be proven safe and effective. (Under the Nutrition Labeling and Education Act of 1990, certain health claims are permitted on foods; however, there is no approved health claim applicable to "smart" drinks.)

Laws affecting "smart" drugs are less complicated. The promotion or sale of drugs for purposes not approved in the United States is illegal.

Unapproved medications used as "smart" drugs typically make their way into the United States through an abuse of FDA's "personal use" import policy.

FDA permits individuals to bring into this country small amounts of drugs for "personal use" when the drugs are sold in foreign countries but not in the United States. However, the drugs must not pose any unreasonable health risks, and must be used to treat a serious condition for which there is no approved treatment here. Permissible personal-use quantities generally do not exceed a three-month supply.

But some individuals have illegally used the "personal use" import policy for commercial gain.

"Once they have the 'smart' drugs in this country, some sell and distribute them for unapproved purposes," said Phillip L.B. Halpern, assistant U.S. attorney, Office of the U.S. Attorney, Southern District of California, San Diego.

More Research Needed

While not endorsing the illegal use of drugs, some health professionals believe that more research into the efficacy of "smart" drugs should be conducted.

Thomas N. Chase, M.D., chief of the Experimental Therapeutics Branch of the National Institutes of Health, said that "smart" drugs need to be looked at more carefully.

"We should take some of these claims seriously enough to evaluate them. Some people feel that there is a conspiracy on the part of the federal government and FDA to withhold certain drugs. This drives them into the hands of entrepreneurs that make promises."

"We're early into this thing," said a 40-year-old writer, who takes a combination of piracetam, Hydergine, L-deprenyl, vincamine, and assorted vitamins. "In ten years, everybody over 35 is going to stop and ask themselves the question, 'Do I want to continue getting old? Do I want my brain to age?'"

And what about the side effects? "There could be long-term side effects," said the writer, who says he's taken "smart" drugs since 1983, "but you would think that after so many years of people taking them some would have popped up."

Looking at "smart" drugs in such simplistic terms, however, can do more harm than good, said Crook. "You're dealing with balance systems in the brain. Any drug that has the ability to enhance cognition can also impair it."

McGaugh went a step further, warning that no one should spend money for a drug that has not been proven safe or effective.

"People are buying hope," McGaugh said. "They are skeptical about scientific claims and they say, 'you guys [the medical community] don't know.' But there simply isn't enough evidence."

FDA maintains that because "smart" drugs have not been subjected to adequate animal and human testing in controlled clinical trials, and have not been proven effective or their toxicity defined, they could be harmful. Strategies for regulating dietary supplements, including amino acids and other nutrients, are currently being evaluated by an FDA task force.

FDA is also working closely with state attorneys general and other state authorities to prevent the illegal sale and distribution of "smart" drugs.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.