On New Year's Eve, Mark Neiber of Health and Fitness Plus was busy ridding his store of fitness supplements containing the herbal stimulant ephedra.
"I took everything out of the store because they said the fine was $5,000 and a potential six months in jail," said Neiber. "Who wants to deal with that?"
On Jan. 1, a statewide law banning the sale of ephedra went into effect, making California the third state to ax the controversial herb.
Michael Creason, in charge of supplement sales at Powerhouse Gym in Pacific Beach, said his customers stockpiled ephedra products the day prior to the statewide ban. "We posted a sign in the gym [on Dec. 31] and people bought it all up," said Creason. "Twenty minutes later we took the sign down."
Creason said ephedra products had comprised 50 percent of the gym's overall supplement sales, creating a noticeable void in revenue after the ban.
Redoubling censure of the herb, on Dec. 30, Bush administration officials, aided by Health and Human Services Secretary Tommy Thompson, descanted on the evils of ephedra as they announced a federal ban, making ephedra the first over-the-counter nutritional supplement to be nixed by the U.S. government. The FDA sent subsequent warning letters to 62 companies marketing ephedra supplements, including San Diego-based Metabolife.
The FDA is slated to issue a rule detailing the specifics of the ban any day-60 days after which those still selling the drug will be in defiance of federal law.
The most loathed and lucrative denizen of the dietary supplement industry, Metabolife, is the subject of an IRS investigation. Three of its executives allegedly skimmed millions from the company and deposited the cash in offshore accounts (Michael Compton, an outside accountant for Metabolife, committed suicide in November). Among other corporate peccadilloes, the IRS claims Metabolife failed to account for $94 million in income from its flagship ephedra product, Metabolife 356, while the company has been accused of covering up some 15,000 customer complaints, ranging from insomnia to death.
Asked why the complaints weren't made public, Metabolife spokeswoman Jan Strode cited privacy issues. "In California," she said, "there is a privacy-issue law and under DSHEA [the Dietary Supplement Health and Education Act], we were not required to even take these calls, but we chose to."
Many believe the government has taken aim at ephedra in hopes of taking out a much larger target-DSHEA. Signed into law by President Clinton in 1994, the law was a response to the FDA's 1993 announcement that it intended to regulate all dietary supplements as "drugs." Though DSHEA prevented companies from making certain health claims, it allowed supplements to be marketed without prior approval of safety or efficacy by the FDA-unlike pharmaceutical drugs.
Opponents of the ban note that the pharmaceutical industry would have the most to gain from putting the breaks on the lucrative dietary-supplement market, which in 2002 raked in $1.3 billion alone in ephedra sales.
"I have my own personal feelings about why the FDA pulled it," said Jinna McDonough, co-owner of Viva Nova Health Foods in Coronado. "Intrinsically, there's nothing wrong with ephedra.... Every year in this country, more people die from prescribed medications than the people dying from some herbal supplements in 10 years-and these are things their doctors are prescribing freely.... This doesn't seem to be outraging anybody and the FDA doesn't seem to be banning these substances."
Asked whether Metabolife plans to challenge the ban, Strode said the company was "still waiting on the final rule.... Once we see it, we will be weighing our options heavily."
A source of the drug ephedrine-commonly used in over-the-counter cold medications-ephedra has been used in Chinese medicine for more than 3,000 years. Also known as ma huang (meaning yellow hemp), six varieties of the twiggy, shrub-like plant can be found in the desert and canyon areas of San Diego County, though the effects of the local variety are negligible compared to its potent Chinese counterpart.
Ephedra became a target of politicians in the mid '90s, ostensibly due to adverse effects ranging from nervousness, vomiting and profuse sweating to angina, heart attack and stroke-side effects also associated with prescription diet drugs such as Tenuate and Phentermine.
Opponents say the arsenal the FDA used to justify the ban was feeble, and that warning labels already in place should have been caveat enough.
"Why don't they ban cigarettes? Why don't they ban alcohol?" asked Rocco Mediate, a local fitness trainer who said he has used ephedra for years without incident. "We know for a fact that cigarettes and alcohol have killed millions of people over the last 20 years.... My grandmother died from emphysema; I don't know anybody that died from ephedra. Let's face it, if you drink too much vodka cranberries you're going to die."
Perhaps nothing stoked the fires of the ephedra ban more than the highly publicized death of 23-year-old Baltimore Orioles' pitcher Steve Bechler, who keeled over after taking the ephedra supplement Xenadrine on Feb. 17, 2003.
Though politicos were quick to link Bechler's death to ephedra, several doctors and Bechler's own teammates noted an array of extenuating circumstances, including a lack of solid food in Bechler's system, a history of borderline high blood pressure and multiple layers of clothing he was wearing to help him lose weight.
Though state law stipulated that ephedra could only be sold to those 18 and older, causing Neiber and others to card customers, one block down from Neiber's store, those still desiring the ephedra edge can circumnavigate the law in the cold and flu section of Rite Aid pharmacy.
Cough syrups and cold medications like Sudafed all contain pseudoephedrine, a synthetic source of ephedrine that can easily be converted into methamphetamine by unscrupulous kitchen chemists (because of this, state law prohibits the sale of more than three packs of pseudoephedrine-containing tabs at one time).
Though the NFL has officially banned ephedra, Sports Illustrated once referred to Sudafed as the "little helper" many NHL players use to gain a pre-game edge. Many thrill-seeking teens denied ephedra-based "herbal ecstasy" products are probably already acquainted with their local pharmacy, as rap artists extolling the effects of "sippin' on the syrup" have made cough syrup a choice, easy-access high. Many non-prescription syrups, such as Robotussin, contain a drug called dextromethorphan (DXM), which the DEA has attributed to liver damage, brain damage and heroin-like overdose deaths.
So why doesn't the FDA ban these substances? It comes down to a "risk versus benefits" argument that FDA officials, politicians and members of the California Poison Control System (CPCS) are hard-pressed to deviate from.
Among those toeing this line and decrying ephedra use is Dr. Christine Haller, CPCS's resident ephedra expert.
Haller was among those who testified against ephedra alongside Susan Davis and Jackie Speier in a 2000 state Assembly hearing touting Davis' initial anti-ephedra legislation. (Speier vehemently denounced the herb after supposedly having taken it herself over a one-week period.)
Though Haller noted "a lot of side effects" with the prescription diet drug Phentermine, she said comparing ephedra to pharmaceutical counterparts was an "apples to oranges" scenario, because of the rigorous testing necessary for the FDA to approve new drugs.
Now a member of Congress, Susan Davis lauded the FDA's recent ban, touting her own pending legislation, the Dietary Supplement Access and Awareness Act. Among its mandates, the bill would require the dietary-supplement industry to report all serious adverse events to the FDA within 15 days and give the FDA authority to inspect industry safety records.
Asked how the ephedra ban would be enforced, FDA spokeswoman Laura Alvey said the agency's focus would be on "retailers and manufacturers.... It's not going to be illegal for a consumer to possess the product once the rule goes into effect."
As to whether the FDA would pursue those who purchase the drug online, Alvey said, "If they were trying to get it mailed from Canada, it would be subject to seizure, because it's not legal in this country."
Alvey also touted the "risk versus benefits" argument for banning ephedra. "I mean, drugs go through years of clinical testing. There's nothing that a dietary supplement has to do. They don't even have to register with us."
To date, Alvey attributed 162 U.S. deaths to ephedra use.
However, the RAND report, a study commissioned by the National Institutes of Health that was heavily cited in the FDA's case against ephedra, noted only five "sentinel" deaths related to ephedra.
"The RAND report says that we need a large-scale study; it doesn't call for a ban," said Mike Fillon, author of Ephedra Fact & Fiction, an account of the government's case against ephedra that largely points to drug company interests. "There were only five deaths that they could find, not 155 like so many reporters are reporting. I don't even know where they're getting that number. That's an old FDA number that was laughed out of Congress. For example, there was a woman that hit a tree at 90 mph and died. She had taken ephedra, but her alcohol level was already two-and-a-half times the legal limit."
Though several representatives for the California Poison Control System hedged at commenting about the incidence of adverse-event calls related to ephedra, Dr. Rick Clark, medical director of the San Diego division of the California Poison Control System, said calls were fairly infrequent.
"Maybe we get a call every other day... but most of them are really minor things-tremor, people feeling a little jittery.... It's not that prevalent.... Most people know what's doing it, because most of the symptoms they get are pretty mild. It feels like you've got a big shot of No-Doz and they just cut back on it or stop if they don't like it. Some people like that feeling.
"The bad stuff, like Bechler and the rest of these guys had, where they get hypothermic and they have cardiac dysrhythmia are pretty darn rare. When you look at it, out of the millions of people that are using the stuff, it's probably 100 cases a year, and that's probably overestimated-and half of those are probably unrelated, to tell you the truth....
"You know," added Clark, "as much as I hate Metabolife-like everybody else-they're probably not far off the truth, that if people take these drugs correctly, it's probably not going to hurt that many people."