It is still legal to purchase to use for bronchial constriction, asthma ect. In some states, like NV, it is regulated if you buy more than six bottles. What I mean by regulated in NV is they track larger sales of the stuff. I believe most of the states that do track it are located in big metamphetamine states like NV, AZ, CA, OR, ect. I would not consider buying bulk quantities of the stuff, just asking for the feds to come knocking. Not that you are doing anything illegal, just not worth the hassle.
Right off the FDA website ruling. 2004
What Products are Covered?
This final rule applies to dietary supplements containing ephedrine
alkaloids, including, but not limited to, those from the botanical
species Ephedra sinica Stapf, Ephedra equisetina Bunge, Ephedra
intermedia var. tibetica Stapf, Ephedra distachya L., Sida cordifolia
L. and Pinellia ternata (Thunb.) Makino or their extracts. The
ingredient sources of the ephedrine alkaloids include raw botanicals
and extracts from botanical sources. Although synthetic ephedrine (in
the form of ephedrine hydrochloride) has been found in products labeled
as dietary supplements, ephedrine hydrochloride was approved for use as
a human drug as early as the late 1940s and, to the best of our
knowledge there is no evidence that it was marketed prior to that time
as a dietary supplement or food. Furthermore, ephedrine hydrochloride
and other synthetic sources of ephedrine cannot be dietary ingredients
because they are not constituents or extracts of a botanical, nor do
they qualify as any other type of dietary ingredient. For these
reasons, products containing synthetic ephedrine cannot be legally
marketed as dietary supplements (See section 201(ff)(1) and
201(ff)(3)(B) of the act (21 U.S.C. 321(ff)(1) and (ff)(3)(B))). In
October 2001, we brought a seizure action against $2.8 million worth of
finished drug products containing synthetic ephedrine hydrochloride
that were labeled as dietary supplements (United States v. 1009 Cases *
* * E'ola International AMP II), No. 2:01CV-820C (D. Utah filed October
22, 2001)). As a result of this seizure, in 2002, the manufacturer
signed a consent decree agreeing to the condemnation and destruction of
the seized products and prohibiting it from manufacturing or
distributing violative ephedrine hydrochloride products. In other
actions, we have sent warning letters to multiple firms that were
marketing products containing synthetic ephedrine alkaloids as dietary
supplements, resulting in the removal of the illegal products from the
market.
The final rule does not apply to conventional food products that
contain ephedrine alkaloids. Substances intentionally added to a
conventional food are generally considered to be food additives under
section 201(s) of the act. Ephedrine alkaloids contained in
conventional foods would generally be considered unsafe food additives
(see section 409 of the act (21 U.S.C. 348)). A food that contains an
unsafe food additive is adulterated under section 402(a)(2)(C) of the
act.
This final rule also does not include OTC or prescription drugs
that contain ephedrine alkaloids. The use of ephedrine or
pseudoephedrine for the treatment of asthma, colds, allergies, or any
other disease is beyond the scope of this final rule. Ephedrine is
allowed as an active ingredient in oral OTC bronchodilator drugs for
use in the treatment of medically diagnosed mild asthma (Sec. 341.16
(21 CFR 341.16)), when used within the established dosage limits and
when the product is labeled in accordance with the required statements
of identity, indications, warnings, and directions for use found in
Sec. 341.76. In the near future, we intend to propose revisions to Sec.
341.76 to reflect current scientific information about the risks of
ephedrine. Both ephedrine (topical) and pseudoephedrine (oral) are
permitted as active ingredients for use as nasal decongestants (Sec.
341.20), when they are used within the dosage limits established by and
labeled in accordance with Sec. 341.80. The topical use of ephedrine
will not be further discussed in this rule because it is not relevant
to oral consumption of ephedrine in dietary supplements. The use of
ephedrine alkaloids in drug products is discussed in more detail in
section V.B.3 of this document.
Several Ephedra species (including those known as ma huang) have a
long history of use in traditional Asian medicine. These products are
beyond the scope of this rule because they are
[[Page 6794]]
not marketed as dietary supplements. The use of ephedrine alkaloids in
traditional Asian medicine is discussed in more detail in section V.B.5
of this document. As we describe there, this rule does not change how
these products are regulated under the act.
(Comment 1) One comment stated that we coined the term ``ephedrine
alkaloids'' to improperly broaden the scope of the published scientific
literature and AERs cited in the June 1997 proposal. The comment
pointed out that ephedrine, pseudoephedrine, and phenylpropanolamine
(PPA) are all different chemical entities and stated the opinion that
only data on ephedrine are relevant to the June 1997 proposal.
(Response) Although we agree that the terms ephedrine,
pseudoephedrine, and PPA refer to different chemical entities, we
disagree with the rest of the comment and its conclusions. The term
``ephedrine alkaloids'' refers to a class of naturally occurring
compounds structurally related to ephedrine, and the term has been used
in that manner in the scientific literature (Refs. 25 and 26). We chose
this particular term, rather than several alternatives, such as
``Ephedra bases'' and ``ephedrine type alkaloids,'' to limit the scope
of the June 1997 proposal to those compounds that are natural
constituents of the aerial parts of the Ephedra plant or other
botanical sources of ephedrine and related alkaloids. We also defined
the term by listing the six principal natural alkaloids in the June
1997 proposal and other FDA documents (Refs. 6 and 27). The ephedrine
alkaloids in botanicals include l-ephedrine, d-pseudoephedrine, l-
norephedrine, l-methylephedrine, d-norpseudoephedrine, d-
methylpseudoephedrine, and minor related alkaloids. All of these
compounds are pharmacologically active substances in the plant.
Therefore, we considered all of them in our evaluation of the risks
associated with the use of the botanical or extracts from the
botanical. However, as discussed in the response to comment 24 in
section VI.B.1 of this document, we recognize that there are some
differences between ephedrine and PPA.
(Comment 2) Several comments asked whether North American species
of Ephedra (e.g., Mormon Tea) are covered in this rulemaking.
(Response) Most North American species of Ephedra (e.g., Mormon
tea) do not contain ephedrine alkaloids (Refs. 2 and 26). Nonetheless,
any dietary supplement that contains ephedrine alkaloids from any
botanical source, including from a North American species of Ephedra,
is subject to this rulemaking.
ENZO