2016-08-30

nasal B12 works? turned into prescription only

8.23: web.cook/b12/nasal B12 gel:
what happened to nasal b12? considered a drug?
make it yourself?
find a high dose pill with no silicates:
Now Foods, Methyl B-12, 10,000 mcg,
Xylitol, sorbitol, cellulose, citric acid,
stearic acid (vegetable source) and natural flavors.
Jarrow:
. some complain potency went down
and Jarrow themselves warn the color varies from light pink to red.
(b12 has a dark red color).

the end of Ener-B Nasal Gel ("Ener-B"):
This Court referred to Judge Ross the issue of whether
Ener-B is a "food" or a "drug" within the meaning given to these terms
by the Federal Food, Drug and Cosmetic Act ("FDCA" or the "Act"),
21 U.S.C. §§ 301-395 (1988 & Supp. V 1993)
(unless otherwise indicated, all citations to the U.S.C.
are to the 1988 edition and 1993 volume supplement).
Judge Ross found that the Food and Drug Administration ("FDA")
reasonably determined that Ener-B was a drug
and not a "food" within the meaning of
sections 201(f) and 201(g)(1)(C) of the Act,
21 U.S.C. §§ 321(f) and 321(g)(1)(C).
The defendant markets Ener-B,
which is intended to be applied to the inside of one's nose.
As intended to be used, the vitamin B-12 contained in Ener-B
bypasses digestion through the gastrointestinal tract,
where it would be absorbed into the body through the intestines.
Instead, Ener-B's vitamin B-12 is absorbed directly
into the blood stream through the nasal mucosa.
On February 26, 1987, the FDA notified Nature's Bounty
that the FDA considered Ener-B to be a "drug" under the FDCA,
and that Ener-B was being marketed illegally
because it had not received recognition or approval
as a "new drug" under the Act.
The FDA also alleged that Ener-B was misbranded
and improperly labelled under the Act.
--
here's the legal drug:
Nascobal Gel (Cyanocobalamin, USP)
Intranasal Administration has been approved as
therapy for vitamin B-12 deficiency.
Subjects requiring more than the normal amount of vitamin B-12
due to pregnancy, hepatic or renal disease
can also be treated with Nascobal.
Nascobal is a self-administered nasal gel.
The recommended dose of Nascobal
in subjects with vitamin B-12 malabsorption who are in remission
following injectable B-12 therapy
is 500 mcg/0.ImL administered intranasally once weekly.
Inactive Ingredients:
SODIUM CITRATE
CITRIC ACID MONOHYDRATE
GLYCERIN
BENZALKONIUM CHLORIDE