To Ban Sale of Dietary Supplements Containing Ephedra
Is “re-regulation” of
the dietary supplement industry on the horizon?
Bioterror detention for non-compliance?
a precedent setting action the FDA announced on December 30, 2003 that
it will issue a rule to ban the sale of dietary supplements containing
ephedra. The FDA also said it is sending letters to 64 firms which distribute
or manufacture dietary supplements containing ephedra telling them that
the FDA will begin enforcing the ban as soon as the rule becomes final;
thereby, apparently precluding any phase out of banned product inventories
after that date.
FDA, which for years has proposed restrictions on the marketing of
dietary supplements containing ephedra, is basing its action on a
RAND corporation study that the FDA commissioned. Based on the results
of the study, the FDA has concluded that ephedra containing dietary
supplements represent an “unreasonable risk of injury or illness” under the federal
Food, Drug & Cosmetic Act. The letter to the distributors states
that FDA will begin enforcing the rule 60 days after it becomes effective.
The 60 day delay is to allow for congressional review or as it is more
commonly called “congressional veto.” According to an FDA
Q&A release, the proposed rule will be published in the Federal
Register in “a few weeks” for public comment. The Q&A
does not state when FDA anticipates that it will issue a final rule.
In addition to the 60 day congressional veto period, completion of
the rule making process will probably take several months.
Since 1997 the FDA has considered proposals to place limits on the use
of ephedra in dietary supplements, but FDA action has been limited by
the restrictions in the 1993 Dietary Supplement Health and Education
Act, commonly known by its acronym DSHEA. Under DSHEA products marketed
as dietary supplements are generally subject to a much lesser degree
of FDA oversight than products that are marketed as food or drugs. Several
public interest groups have vehemently opposed DSHEA and it is expected
they will use ephedra as a spring board to call for broad changes in
FDA’s Q&A also stated that it did not classify ephedra containing
dietary supplements as an “imminent hazard to the public health,”
because the classification of a substance as an “imminent hazard”
is subject to a much higher legal standard than the “unreasonable
risk” classification, and the FDA was “less confident”
that an action under the imminent hazard standard would be sustainable.
Use of the “imminent hazard” standard would have expedited
the rule making proceeding to ban ephedra’s use.
Not addressed in the FDA’s materials is the possibility of the
agency taking action under the administrative detention authority that
was given it in the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the “Bioterrorism Act”). Although
the FDA has delayed at least until March 2004 final rules implementing
its detention authority, such rules are not required by the Bioterrorism
Act as a prerequisite for the FDA using its detention authority. As
readers of prior issues of Food & Marketing Law Update know, the
FDA’s detention authority is an in-house administrative action
that does not require rule making or initial judicial approval. The
standard for exercising this authority is stated in the Bioterrorism
Act is that the FDA has credible evidence or information indicating
that an article of food, which includes dietary supplements, presents
a threat of Serious Adverse Health Consequences Or Death To Humans Or
Animals, fondly known to us and the people who have seen Zackler &
Associates' Bioterrorism Act presentation as SAHCODHA. The threat need
not be related to bioterrorism. Whether or not anyone at FDA ever raised
the issue of administrative detention, it’s pretty clear to us
that although an “imminent hazard” might be SAHCODHA, an
“unreasonable risk” is not.
Issues New Policy Statement Concerning Health Claims on Dietary Supplements & Food
a new effort to comply with the District of Columbia Court of Appeals
decision in Pearson v. Shalala the FDA has issued a new policy statement
concerning “qualified” health claims that can be put on
the labels of dietary supplements and food products. In Pearson the
Court held that the First Amendment limited FDA’s regulation
of truthful health claims on the labels of dietary supplements.
the FDA’s new policy has created a category of “enforcement
discretion” for health claims that do not meet the FDA’s
existing requirement that health claims be substantiated by “significant
scientific agreement.” The new category is based on the “weight
of the scientific evidence”. The FDA’s policy describes
this test as: “The test is not whether the claim is supported
numerically (i.e., whether more studies support the proposed claim
than not), but rather whether the pertinent data and information presented
in those studies is sufficiently scientifically persuasive.”
order to trigger enforcement discretion, the health claim must be submitted
to the FDA through its existing petition process for health claims.
Presumptively, the FDA will exercise (non-) enforcement discretion,
if it determines that although the claim is not supported by “significant
scientific agreement,” it is supported by the weight of the scientific
evidence. The FDA has reserved the right to later exercise enforcement
discretion against a health claim if it determines that the weight
of subsequent scientific evidence shifts against the claim.
rush to file your petition with the FDA. The Office of Nutritional
Products, Labeling and Dietary Supplements, which will be administering
the program, has stated that qualified claims will not be reviewed
by the agency until an implementation phase is completed that could
take as long as six months.
rather peculiar policy is based on the FDA’s position that the
FD&C Act only allows it to approve health claims that meet the significant
scientific agreement test and therefore, the FDA cannot “approve” health
claims that a meet a lesser standard.
remains to be seen whether this new policy will satisfy the plaintiff’s
contention that prior FDA initiatives failed to comply with the requirements
of Pearson. Even if the policy itself meets Pearson’s requirements,
there will probably be issues whether the FDA is honestly administrating
the new policy. We expect more visits to the courthouse before this
is all over.
FDA’s new policy also stated that it is adopting the FTC’s
“reasonable consumer” standard for determining whether a
claim is misleading instead of the statutory “misleading in any
particular” standard. We’ll have to wait and see how the
FDA interprets this new standard and what effect, if any, it has on
FDA enforcement actions. However, it’s a very good bet that your
marketing department's definition of a reasonable consumer won't be
the same as the FDA's.
the FDA has approved a new health claim for products with D-tagalose,
which is commonly called tagalose. Tagalose has been added to the “does
not promote tooth decay” health claim that the FDA has already
approved for products sweetened with sugar alcohols such as sorbitol.
As with many FDA regulations there is a catch. Because tagalose is classified
as a sugar, products that contain it cannot be labeled as “sugar
free.” On the other hand, products which contain tagalose will
not have to list their sugar alcohols content in the Nutrition Facts.
The amended regulation approving the new health claim for tagalose
contains several examples of model claims.
Zackler & Associates can
advise you concerning utilization of the new FDA policy to expand
marketing opportunities for your food and dietary supplements.
FOOTBALL LEAGUE BANS EPHEDRINE USE
National Football League has banned the use of the dietary supplement
ephedrine by its players. The FDA has linked the stimulant to at least
the ban, which will be included in the league’s anti-steroid
policy, players will be subject to year-round random testing for ephedrine.
Further, the league will ban teams and players from endorsing manufacturers
or distributors of ephedrine-based products. Many athletes have used
ephedrine-based supplements for both weight loss and energy boosting.
The National Collegiate Athletic Association and the International
Olympic Committee have long banned the use of ephedrine supplements
by its athletes.
ACCUSED OF SPIKING TEA WITH EPHEDRINE
Council for Education and Research on Toxics, a Los Angeles based public
interest group, has filed suit against Starbucks Corp., claiming
that Starbucks has secretly spiked its Tazo Chai Tea with ephedrine
since 1996. The lawsuit claims violations of the California Health & Safety
and Business & Professions Codes. The Council seeks to enjoin Starbucks
from adding ephedrine to the tea and to force Starbucks to pay restitution
to the State of California.
ephedrine is legal for use in dietary supplements, the FDA has not
approved ephedrine’s use in food or beverage products under its “Generally
Regarded As Safe (GRAS)” regulations.
has strongly denied the allegations. “We have tested Chai Tea
for the presence of ephedrine and the results have been conclusively
negative,” said Starbucks spokesperson Audrey Lincoff. “Ephedrine
has never been used as an ingredient in Tazo’s Chai Tea or any
other Tazo product. There are no basis to the claims raised by the
plaintiff and we intend to vigorously defend the lawsuit.”
ISSUES WARNING OVER LIPOKINETIX
FDA has warned consumers to immediately stop using the dietary supplement
Lipokinetix®, marketed by Syntrax Innovations, Inc. The warning
was issued after FDA received multiple reports of liver damage from
consumers who were taking the supplement. Lipokinetix is marketed
as a weight loss product. Its contains the ingredients norephedrine,
caffine, yohimbine, diodothyronine and sodium usniate. All reported
liver injuries appeared in consumers between the ages of 20 and 32.
Onset of damage took as long as three months to occur. Symptoms included
nausea, weakness or fatigue, abdominal pain or any change in skin
Zackler & Associates. All rights reserved.