On April 13, 2005, a federal court in Salt Lake City [U.S.
District Court for the District of Utah, Central Division] issued
its decision on a legal challenge to FDA's 2004 Final Rule banning
all ephedrine-alkaloid dietary supplements. Judge Tena Campbell's
decision made two key points:
It held that the analysis used by FDA was incorrect and
improper. FDA's analysis weighed risks against benefits. The
Dietary Supplement Health and Education Act (DSHEA), however,
requires a straightforward risk assessment. The court held that
requiring supplement companies to demonstrate a benefit as a
pre-condition to marketing violated DSHEA by shifting the burden
from FDA to industry. [This issue was explored in a 2004 article
I co-authored with Alan Feldstein, Esq., and published in the
Sports Nutrition Review Journal (also accessible online through
www.steroidlaw.com.]
It held that FDA didn't have adequate scientific evidence to
find that a daily dose of 10 mg. or less of ephedrine alkaloids
presented a "significant or unreasonable risk of illness or
injury" [under 21 U.S.C. § 342(f)(1)(A)]. The court effectively
held that it's improper to ban all ephedra supplements because
FDA lacks data to determine what dosage might be safe.
The case isn't necessarily over yet. FDA may appeal, and the 10th
Circuit Court of Appeals might reverse the district court's ruling.
Meanwhile, FDA may seek a stay to block renewed ephedra sales while
the matter is pending.
So where does this leave ephedra supplements? My firm has been
besieged by calls from curious supplement manufacturers seeking
advice. Some aggressive supplement companies have already renewed
online ephedra product sales. But companies contemplating a return
to the ephedra market should first discuss the issue with
knowledgeable legal counsel familiar with what may well be a fluid
and changing landscape. The Utah decision should not be viewed as
carte blanche for everyone to sell ephedra products. The scope of
the decision has yet to be clarified, and legal minds can differ as
to how "narrowly" to interpret the ruling. For example, the
narrowest interpretation would be that the decision only applies to
the products made by the company involved in the lawsuit, since
those were the only products that were specifically the subject of
the suit. One trade association has already voted to require a
pledge not to sell ephedra products at any dose as a condition of
membership. Certainly, before any company proceeds, there are at
least four issues which must be considered:
Dosage. The ruling only addresses low-dose products (10 mg.
or less daily). Many ephedra supplements prior to the ban
contained up to 100 mg. in total daily dosage. Significantly, a
New Jersey lawsuit claiming that FDA didn't demonstrate
unreasonable risk with respect to higher dose ephedra products
was resolved last year in FDA's favor. The ban remains in place
for high-dose products.
Jurisdiction. FDA may interpret the ruling as binding only
in the court's Utah district, and could take action against
ephedra products in other jurisdictions. In fact, FDA did
exactly that in the early 1990s with respect to black currant
oil capsules. When the agency lost in a Chicago court, it took
action in a Boston court for sale of the same product. Also, the
federal court decision doesn't preempt state laws banning
ephedra, so sales would still be illegal in states such as
California, Illinois, New York, and other states which may pass
anti-ephedra legislation.
Importation. Companies seeking to reenter the market also
need to think about how to obtain the raw materials. The embargo
against importing ephedra is not voided by the ruling. FDA may
take enforcement action against companies seeking to import the
ingredient.
Products liability. The court ruled that FDA failed to prove
that low doses of ephedra are dangerous, but did not
affirmatively rule that low doses of ephedra are safe. "Prior to
the FDA ban, the ephedra supplement market was being crushed by
the spiraling costs of product liability insurance - and the
refusal by some carriers to insure ephedra products at all,"
points out Alan Feldstein, an authority on ephedra supplements
and Of Counsel to my law firm, Collins, McDonald & Gann. "Also,
this ruling will probably not stop trial lawyers from continuing
to bring suits alleging ephedra products are inherently
dangerous," adds Feldstein.
Predictably, anti-supplement activists are denouncing the decision.
A senior policy analyst for the Consumers Union, publisher of
Consumer Reports, shrieked: "This is just nuts. Bringing ephedra
back to market even at low doses is dangerous." But the decision may
have key implications beyond ephedrine alkaloids. Critics have
renewed their cries to repeal or reform DSHEA, saying that the
ruling is evidence that DSHEA prevents FDA from pulling dangerous
products from store shelves. The watchdog group Public Citizen
claims DSHEA has been a "disaster" and should be repealed. The New
York Times ran an editorial urging the White House and Congress "to
move promptly to enact overdue legal revisions that will
significantly strengthen [FDA's] power to monitor and police the
supplement industry." Voices from Capitol Hill are joining the
chorus. "If FDA can't take a supplement as dangerous as ephedra off
the market, then Congress needs to change the law to allow it to do
so," Sen. Edward Kennedy (D-Mass.) said through a spokeswoman. Rep.
Henry Waxman (D-Cal) wants to revisit DSHEA to "give FDA the
authority it needs to protect American consumers from dangerous
supplements." [Industry members concerned about the reinvigorated
attack on DSHEA and seeking advice on what to do about it should
feel free to call my office.]
But not everyone's jumping on the anti-ephedra bandwagon. "While
ephedra might be more dangerous than, say, a multivitamin, its
risks, which stem mainly from stimulating the cardiovascular system,
are well within the range considered acceptable for OTC
[over-the-counter] drugs," points out syndicated columnist Jacob
Sullum in a recent Washington Post article. "The FDA, the medical
establishment and the pharmaceutical industry all want to prevent
emergence of an alternative drug market in which consumers can
obtain cheap, effective and reasonably (though not completely) safe
products without permission from the government's gatekeepers."
Will consumers see lose-dose ephedra supplement products return
to the shelves soon? Quite possibly, but the long-term future of
this supplement remains shrouded in uncertainty. For specific advice
to industry based on the latest developments regarding ephedra,
contact my law firm at 516-294-0300 or info@cmgesq.com.
