Amino Acids, Herbs, Other Supplements: FDA Proposes New Regulations, Public Comment Until August 17

The FDA is planning major changes in how it regulates dietary
supplements. The most drastic proposal concerns free-form
amino acids, which the FDA wants to make prescription drugs.
In a second category, herbs, the FDA is exploring approaches
to regulation to assure safety of herbal products. Vitamins
and essential minerals may have the least regulatory changes
(although one proposal would declare only the recommended
daily allowances (RDAs) as safe, unless manufacturers or
others proved safety of higher doses to the FDA's
satisfaction). In the fourth category, "other" supplements
(including fish and plant oils, other lipids, dietary fiber,
and miscellaneous, sometimes dangerous substances such as
germanium), the FDA is asking for public comment on
approaches to regulating safety.

These proposals were published in the Federal Register,
Friday, June 18, 1993, pages 33690 through 33700. [Note:
Three other sets of proposals on dietary supplements follow
in that issue, on pages 33700 through 33751. These mainly
concern industry, however, because they propose to regulate
requirements for making a health claim for a dietary
supplement, how the labels on the bottles must look, and the
exact definition of claims such as "less", "reduced",
"fewer", or "no added sugar."]

The FDA is legally required to prepare new rules for
regulation of dietary supplements by the end of 1993. To be
considered in this rulemaking, public comments must be in
writing and received by August 17 at:

Dockets Management Branch (HFA-305)
Food and Drug Administration, rm. 1-23
12420 Parklawn Drive
Rockville, MD 20857.

Comments should be identified with docket number 93N-0178.
Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments received are open
to public inspection in the Dockets Management Branch between
9 a.m. and 4 p.m. Monday through Friday.

Comment

We are most concerned with the proposal to take amino acids
off the market. The AIDS community has barely begun to
explore amino acids so far (except for NAC, which is a close
relative of an amino acid, and lysine, which is widely used
as an "underground" herpes treatment). These food substances
have been proposed for a great many medical purposes. We fear
that AIDS-related uses will never be explored, at least not
in the foreseeable future, if these potential natural
therapies are taken away from patients and physicians and
turned into pharmaceutical-company monopolies.

Our concern with other aspects of the proposal is that it is
not specific, and yet the FDA is under pressure to make new
rules by December of this year. As a result, it is hard for
the public to engage meaningfully with these proposals --
which also are complex, technical, and related to a vast
array of legal, medical, and policy issues. Therefore, the
final rules are likely to come out with little real public
input. The public must trust the FDA to respect its demand
for maximum possible access and choice consistent with safety
-- and must be ready to fight the Agency in the courts and in
Congress if this trust is abused.