Retailers must stop selling ephedra products by April 12 or they could face penalties from the Food and Drug Administration or, at the local level, the Ohio State Board of Pharmacy.
The Ohio State Board of Pharmacy, a law enforcement agency, licenses all places where prescriptions are stored, such as pharmacies and hospitals.
We are charged with enforcing drug laws in the state of Ohio
said William Winsley, pharmacy board executive director. We have enforcement powers for more than our individual licensing chapter. That's why we're so involved in these outside programs and situations like ephedra.
Because ephedra will be an illegal substance, the pharmacy board can enforce the ban at the state level, Winsley said.
Depending on the case, the FDA usually sends a warning letter prior to legal action if retailers do not stop selling the drug, Winsley said.
Their ordinary process is a letter and then only if you fail to (stop selling ephedra) do they take the next step either civil injunction or else a criminal case
he said.
Civil action would involve a court document ordering the retailer to stop selling ephedra, while criminal action would criminally indict the retailer for violating federal law. Criminal charges carry the potential of jail time and fines, Winsley said.
The pharmacy board uses similar enforcement tactics, he said.
When ephedra is banned, it will be added to the U.S. Drug Enforcement Administration's Controlled Substance list, Winsley said.
Ephedrine, the chemical extract in ephedra, is classified as a Schedule V substance on the list. Because ephedra contains ephedrine, the supplement becomes a Schedule V as well, he said.
Substances can be labeled on a range from Schedule I, which are narcotics such as heroine and LSD, to a Schedule V.
Ephedra is being dragged back into controlled substance status because there are no legal mechanisms to sell
he said.
On the local level, Athens County Prosecutor C. David Warren said pharmacies or stores that continue to sell ephedra after the ban could be charged with trafficking in drugs.
Warren said selling a Schedule V substance carries a misdemeanor charge.
But the likelihood of retailers continuing to sell ephedra is minimal, said Ralph Fucetola, a New Jersey attorney who consults with vitamin companies.
It would be difficult for companies to sell ephedra because they would not be able to get insurance. Insurance companies now are excluding ephedra-related injuries from their policies, Fucetola said.
It would not be economically feasible for smaller retailers or manufacturers to continue selling ephedra, he said.
I believe it's true to say the insurance industry very effectively removed ephedra from the marketplace
Fucetola said.
Some members of the pharmacy board are pleased with the FDA's actions.
What we're really hoping is that people will realize that this has been and still is a dangerous substance and should not be taken
Winsley said. I'm glad the FDA stepped in and took action at the national level.
Winsley said Ohio has long recognized the dangers of ephedra.
We've known for a long time these products cause problems
he said. Ohio had taken action a long time ago
and there were some other legislation passed that watered it down. We knew it was a struggle.
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