The FDA Eyes Your Garden
Even before the Food and Drug Administration (FDA), released its final ruling on the herb ephedra, banning it for sale after April 12, the feeding frenzy had begun.
Many see the FDA's action to prohibit the sale of ephedra, or ma huang as it's also known, as the opening salvo of an attack on all supplements, especially botanicals, and the landmark law that protects them, 1994's Dietary Supplement Health and Education Act (DSHEA). They fear that if the supplement act is overhauled or rescinded, millions of consumers may be denied access to what are mostly safe, effective and inexpensive wellness enhancers and alternatives to prescription drugs.
"We're not saying, 'don't sell them.' We're saying, 'don't sell them over the counter.' Regulate them as you regulate prescriptions." So said Rep. John Sweeney, (R-NY), at a Feb. 3 press conference announcing an initiative to extend the ephedra ban to what he and Sen. Charles Schumer, (D-NY) called 'copycat' formulations to ephedra. Rep. Sweeney said that "Congress made a mistake" when it passed DSHEA. Sen. Schumer added that if FDA fails to act, "We will move legislation in this regard."
While critics say that the products are unregulated or underregulated and pose untold risks to the health of a nation, another group, advocates of alternative and complementary medicine, sees supplements as the cornerstone of a rational and overdue approach to healthcare. The national healthcare system currently consumes 15 percent of the nation's overall spending -- higher than any other industrialized country. And even as insurance companies continue the upward spiral of annual rate increases, 40 percent of the citizens in the richest country on earth are without basic healthcare coverage.
Ephedra sinica. Love it or hate it, use it or not, no dietary supplement has raised the hackles of and polarized so many consumers, government officials, politicians, scientists and the industry that sells it. Additionally, no supplement has ever been so misrepresented, attacked and slandered in mainstream media. And while the door on ephedra is closing, the face-off in this complex and emotionally charged story continues.
Curiously, the ban on ephedra will not affect the sale of over-the-counter and prescription drugs containing the herb's synthetically derived active compound ephedrine, which is used in decongestants and other bronchial remedies such as Sudafed.
An Old Familiar Feeling
This situation looks strangely similar to the agency's 1990 banning of the amino acid L-tryptophan. This then-popular dietary supplement, used to relieve depression, anxiety and PMS, as well as to control pain and induce natural sleep, was implicated -- and then cleared -- in the deaths of a number of users in the U.S. in 1989. Investigators found that a faulty manufacturing process at a Showa Denko facility in Japan was responsible for a contamination of the product, which caused a deadly flu-like condition called Eosinophilia-Myalgia Syndrome (EMS).
Surprisingly, L-tryptophan is still available by prescription, but at a much higher cost, and it has been used, uninterrupted, in baby formulas and animal feed since the 1989 incident. In fact, in 1993, a U.S. patent was issued to use L-tryptophan to treat and cure EMS, the same condition that prompted the FDA to take L-tryptophan off the market in the first place. Go figure.
Now, some observers are looking suspiciously at the 2002 FDA approval of Eli Lilly's drug, Strattera, a non-stimulant drug, which is used to treat Attention Deficit Hyperactivity Disorder (ADHD). Psychiatrists, who have been increasingly diagnosing adults with ADHD, have typically treated them with stimulants. According to an article in the October 2002 issue of Current Psychology, stimulants produce significant improvement in 30 percent of patients and mixed results in another 40 percent. Ephedra, of course, is such a stimulant.
In its Feb. 6 ruling, FDA provided what it says is a blueprint for how the agency intends to regulate supplements in the future and remove from the market those that it considers "an unreasonable risk" to public safety. While it's too early to tell exactly how the agency will implement its new strategy (the final ruling was released right at press time), a few indicators don't bode well for the industry or consumers.
During a speech at the University of Mississippi in January, FDA Commissioner Mark McClellan said: "We will be doing more work in the coming months to more closely evaluate the potential safety risk of these products, and we could take further action to remove unsafe dietary supplements from the market." On the hit list: bitter orange, aristolochic acid and usnic acid -- all used for weight loss, and chaparral, comfrey, willow bark and wormwood. No one knows what might be next.
The ban of ephedra marks the first time the agency has removed a dietary supplement under DSHEA, passed by Congress after many years of contentious, often hostile clashes from the two opposing sides of the supplements issue. Through the spirited actions of citizen-based advocacy groups, industry companies and health food store retailers, hundreds of thousands of consumers communicated with their congressional representatives in the early '90s demanding continued, unfettered access to dietary supplements. The outpouring was unprecedented at the time, eclipsing everything but commentary over the Vietnam War years earlier.
In passing the DSHEA, Congress stated that there may be a positive relationship between sound dietary practice and good health, and although further scientific research is needed, there may be a connection between dietary supplement use, reduced healthcare expenses and disease prevention.
At the time of its passage, President Clinton said about DSHEA (pronounced "da-shay" for shorthand): "After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law."
The legislation, in essence, amended the Federal Food, Drug, and Cosmetic Act of 1938 to alter the way dietary supplements are regulated and labeled. DSHEA, for the first time, created a legal definition for dietary supplements as foods and not drugs. The law also allowed specific, science-based structure/function claims on supplement labels, which enabled manufacturers (for the first time) to educate consumers about the health benefits of the products as they related to particular health conditions.
The passage of DSHEA was to mark the beginning of a golden era for supplements and natural health. Ten years later, that dream has crumbled.
Risks and Benefits
In trying to understand the heated and often contentious debate on ephedra, supplements in general and the viability of DSHEA, one must understand what everyone involved refers to as the "benefit-to-risk ratio" of consumer products as they relate to public health policy. In the case of ephedra, FDA determined that the herb, traditionally used to help alleviate allergy and asthma symptoms for more than 5,000 years, but now used mostly for weight loss, energy and performance enhancement, had no health benefits and created grave risks to public health -- primarily increased blood pressure that could lead to heart failure and disease.
At a news conference announcing the upcoming ephedra ban, Health and Human Services Secretary Tommy Thompson said government scientists had concluded ephedra-based supplements "are simply too risky to be used."
By comparison, the agency's stand on pharmaceutical drugs is that the benefits outweigh the risks because of all of the supposed safety research that is required before drugs are released for public consumption. That hasn't stopped the agency from releasing, and then recalling, a number of these purported "proven" substances.
A report commissioned by FDA in 2003 and cited in its final ruling found that only five deaths could be directly attributed to the use of ephedra. Yet, media reports and supplements opponents, including the New York legislators mentioned above, quote the number of deaths attributed to ephedra use at 155. According to a report from the American Herbal Products Association (AHPA), 12 million to 17 million people in 1999 consumed approximately 3 billion servings of ephedra products.
On the other hand, according to the Journal of the American Medical Association, overmedication and adverse reactions to pharmaceutical drugs in hospitals killed 106,000 people in 1994. And this doesn't include the number killed outside of hospitals or those deaths that went unreported. It is estimated that aspirin kills 1,000 people per year. And last year, allergic reactions to peanuts killed nearly 100. Apparently, the benefit-to-risk ratio of these products, both the domain of FDA, is OK.
Contrary to FDA's contention in its final ruling, a good amount of scientific research shows that if taken according to label directions and strict dosage limitations (a maximum of 90-100 mg per day), ephedra is safe. As Mike Fillon, author of Ephedra Fact & Fiction (Woodland Publishing, 2003), points out, many of the deaths popularly attributed to the herb involved significant additional factors, making it unlikely ephedra was the main culprit.
It's true that not all products are safe for everyone. Just as all human beings are distinctly unique, with different physical and mental attributes, their physiologies differ, too. Some people are allergic to or can't tolerate certain foods, such as nuts, dairy or corn, to name but a few. This is also true of some drugs and dietary supplements. It's a no-brainer that consumers who are pregnant or have a history of high blood pressure or heart attacks should not take ephedra. And responsible supplements companies have indicated this on their labels for years.
"Ephedra is symbolic of a bigger issue, and that is how we look at the 'assured benefit' vs. the 'acceptable risk,'" says Jim Turner, a Washington-based attorney, who is chair of the board of consumer-advocacy group Citizens For Health (CFH) and the Campaign for Better Health, a project of CFH. "The government has come in with a no benefit/high risk position and is now trying to spread that position to other supplements -- it's guilt by association. This is bad public policy from the consumer point of view.
"The problem is that there is no way to divide the world of products that are safe and effective and unsafe and ineffective for everyone," Turner adds. "Every product will have some positives and some negatives."
Turner says a better approach would be a post-marketing, post-approval surveillance system for both pharmaceuticals and supplements to get the highest benefit-to-risk ratios at a reasonable cost. Such a system would create an early warning system, he says, that would quickly weed out problem products. Failure to implement some workable system will ultimately bankrupt the country, as according to estimates Turner quotes, at the current pace, 40 percent of the country's gross spending will be on healthcare by 2050.
A Biased Media
Adding yet more fuel to the fire in this debate is mainstream media, which has overwhelmingly taken an anti-supplement stance in its coverage of ephedra. Repeated claims in media outlets such as the New York Times, The New Yorker, Associated Press and others that the industry or a particular supplement product is "unregulated" by FDA are simply false. FDA has always had the power to remove unsafe products from the market.
Not that certain members of Congress have heard the message. At least five bills are currently floating around the hallowed halls of Congress that would severely impact the viability of DSHEA. The most onerous of them, inappropriately named The Dietary Supplement Safety Act (S 722), introduced by Sen. Richard Durbin, (D-IL), could restrict access to whole classes of supplements because of only one adverse event report, without proof that a dietary supplement was the cause of the adverse event (remember L-tryptophan?). In addition, the legislation would essentially halt investment in scientific research to prove the health benefits of supplements.
The good news is that Washington insiders report that Durbin's bill has no chance of passage in this session of Congress. But there's always next year, and the year after that.
Both FDA Commissioner McClellan and his boss, HHS Secretary Thompson, have made it clear that DSHEA is not sacrosanct. At the December 30 news conference announcing the impending ephedra ban, McClellan said: "I do think that when FDA reaches a conclusion like this, we ought to be able to carry it out to provide the protection that Americans need. And we will be doing our best to defend this in court. And if that's not sufficient, it may be time to re-examine the act."
And Thompson said in response to a question, "I've already indicated that I would like to see the law changed,"
Not everyone thinks DSHEA needs to be altered, however. Sen. Orrin Hatch, (R-UT), a staunch supplements supporter and a key sponsor of the original DSHEA legislation, last year introduced -- with fellow supplements advocate and DSHEA sponsor Sen. Tom Harkin, (D-IA) -- The DSHEA Full Implementation Act (S 1538). This legislation would give FDA the federal funding it says it needs to fully implement and enforce DSHEA, specifically, an adverse event reporting system, improved health claims analysis and the ability to enforce good manufacturing practices.
"DSHEA is a strong law that properly implemented will protect the interests of consumers," Hatch told a Senate committee in October. "The law gives the FDA abundant tools to remove products that are unsafe from the market.
"In the nine-plus years since DSHEA was enacted, there has been too much talk that the law handcuffs FDA and too little effort to apply the law. It is impossible for this law to protect consumers if it is not enforced," Hatch added.
With ephedra, it appears that FDA is finally enforcing the law -- at least its version of the law. The rest could well be up to the courts, as lawsuits and legal challenges are likely. And like most legal matters, it's all in the interpretation.
Meanwhile, the supplements industry and millions of consumers are collectively holding their breath waiting to see how FDA will use its legal authority to regulate supplements in the future. The fate of many products may hang in the balance. "If it's based on sound scientific principles and based on law, we'll support it," said Michael McGuffin, president of AHPA, just a few days before the final ruling was released.
Ana Micka, president and CEO of CFH and the Campaign for Better Health presents yet another viewpoint: "In spite of the high usage of supplements (more than 30 percent of the population) and alternative health (more than 40 percent) in the U.S., it's not a visible community and not a block of voters.
"There are definitely competing voices in politics, and right now we're not a loud, dominant voice. We have to do a lot of work as a community to organize and present our views for new health and wellness solutions in this country."
This story originally appeared in the March issues of the Dragonfly Media publications (www.dragonflymedia.com)