comment period closes on July 6, 2004.
UPDATE: FDA Issues Final Detention Rule
FDA has issued its final rule pertaining to the detention authority
given it under the Bioterrorism Act of 2002. The rule, which is
similar to the proposal first put forth by the FDA in 2003, provides:
the issuance of this final rule, we are still waiting for the FDA
to issue a “final” or “interim final” rule
pertaining to the Act’s tracking requirements. The FDA has
previously issued “interim final” rules pertaining
to the two other sections of the Bioterrorism Act that affect FDA
regulation, namely facility registration and import pre-notification.
to Ban Sale of Dietary Supplements Containing Ephedra
Is "re-regulation" of
the dietary supplement industry on the horizon?
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.
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 the law.
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.
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.
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