Herbal Mixtures Classed as Drugs in USA  
Posted by ajones -- June 24, 2001
Reprinted from the Baltimore Sun article "Herbal mixtures classed as drugs" by Gail Gibson.
The herbal mixtures came with names like Liquid X, Schroomz and Herbal Opium, and with some heady promises: "Full of shroomy goodness," one label said. "Intensify your smoking adventures," said another.
Despite the illicit-sounding names and claims, Hit Products Inc. of Riverdale in Prince George's County said its products were "dietary supplements" and not subject to government regulation.
But a federal judge blocked their sale last week after determining that the herbal products should be considered unapproved new drugs, designed to mimic the effects of marijuana or Ecstasy and marketed to party-minded young adults.
U.S. District Judge Alexander Williams Jr. said that labeling the products as dietary supplements "constitutes a veiled attempt to circumvent federal anti-drug laws."
"This court," Williams wrote in his June 12 ruling, "declines to carve out a statutory loophole for drug manufacturers attempting to profit from the illegal drug epidemic by masquerading potentially dangerous substances as legitimate dietary supplements."
The case was the latest in a government effort to crack down on street drug alternatives -- typically botanical mixtures that are promoted as inducing the same kind of high as illegal drugs.
Such products increasingly are marketed as dietary supplements, according to officials with the U.S. Food and Drug Administration.
The distinction is an important one, because a 1994 law largely exempted dietary supplements from the same scrutiny that is applied to pharmaceutical drugs.
However, an FDA spokeswoman said, the label does not fit on products marketed as feel-good party drugs.
"It doesn't matter what you call it, if it reacts in your body as a drug, then it's an unapproved new drug," said spokeswoman Laura Bradbard.
Agrees with Justice
In the case against Hit Products, Williams agreed with Justice Department lawyers who argued that the company's products should be considered drugs -- not dietary supplements -- because they are intended to affect the function or structure of the mind.
The judge said the company's advertising promoted that effect.
An advertisement for a product called "Inda-Kind" included a testimonial that Inda-Kind "did the trick, we're all stoked."
Hit Products, which also does business as Riverdale Organics and Dreamworlds, sold the products through magazine advertisements and over the Internet.
Company's argument
The company argued that its products were made entirely of legal herbs and that it had a First Amendment right to make various marketing claims.
Company President Perry L. Hitt, a Florida resident, and attorney Charles H. Nalls of Washington did not return phone calls seeking comment.
In his ruling, Williams held that the government acted properly last year when it seized the company's stock, and he ordered all of the products destroyed.
He also blocked the company from selling any other such product without it undergoing FDA scrutiny as a new drug.
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