pound—originally found in the Periwinkle
plant (Vinca minor) and sold for decades
in supplements for cognitive support and
weight loss—no longer permissible in
This is despite the fact that there are
five NDI notifications for vinpocetine in
the FDA’s database. In each of these five
cases, FDA ruled that the ingredient is safe
based on then-available data. There have
been no surges in vinpocetine related side
effects in recent years that would prompt
such sudden, rapid action.
The move might stem from a push by
Missouri Senator Claire McCaskill, of the
Senate’s Special Committee on Aging, who
in 2015 called on the FDA to suspend sales
of vinpocetine-containing supplements.
Or it may have to do with the fact that
back in 1981, a drug-maker filed an Investigational New Drug application for
vinpocetine and conducted several clinical trials, though no prescription vinpocetine ever came to market in the U.S.
Vinpocetine is sold as the drug Cavinton
If something comes to market first as
a supplement it may be later developed
into a pharmaceutical—think prescription fish oils like Lovaza. But if a compound is first developed as a drug, it can
never be a supplement.
The FDA’s—and Sen. McCaskill’s—
other big argument against vinpocetine
is that most products on the market con-
tain synthetic forms of the compound,
not extracts from plants, meaning that
they are not technically “naturally-oc-
That’s fair enough, from the viewpoint
that natural products should contain nat-
urally occurring ingredients.
But if the FDA applies this logic across
the industry, a vast number of products
will face imminent ban, because synthetic
forms of vitamins, and “bio-identical” botanicals are ubiquitous.
Rather than wanton banishing of in-
gredients, a more meaningful approach
might be to require manufacturers to
disclose the presence of synthetic ingre-
dients on product labels, giving consum-
ers freedom of choice. But given how the
GMO labeling effort panned out, this is
not likely to happen.
DEA Bans—Then Un-Bans—Kratom
In September, the Drug Enforcement
Agency invoked its emergency powers to
classify the herb Kratom as a Schedule 1
drug of abuse.
This Asian herb, which many Americans had barely even heard of prior to the
DEA’s move, has been growing in popularity in recent years among people with
chronic pain, PTSD and anxiety.
Indigenous to Malaysia, New Guinea
and other parts of Southeast Asia, Kratom
(Mitragyna speciosa) is a tropical evergreen
tree, and a distant relative of coffee. It has
a history of traditional use for chronic pain
in Asian countries.
The scope of use in the U.S. is not clear,
but it has been on the rise in the wake
of the opioid addiction epidemic and the
medical community’s growing reluctance
to prescribe opioids.
Though not technically an opiate, Kratom contains alkaloids with both stimulant and depressant effects mediated
primarily through monoaminergic and
opioid receptors in the central nervous
system. Some chronic pain patients say
Kratom is a life-saver.
The DEA says the herb—which people
take in pill or capsule form, or as a tea—is
dangerous, citing risks of addiction, overdose, respiratory depression and seizures.
To make its case for the ban, DEA
points to rising hospitalization rates, and
a whopping 15 Kratom-associated deaths
in the U.S. between 2014 and 2016. That’s
about 7 per year, right up there with lightning strikes, shark attacks, and assaults by
people in clown suits.
CDC data show only 660 Kratom-related reports to poison control centers
between 2010 and 2015, for an average of
132 per year. One quarter of these were
mild and non-life threatening, and 42%
were only moderately serious. While 49
of these cases (7%) were life threaten-
ing, a few of these were in people taking
prescription drugs in addition to Kratom.
Whether the actual adverse events were
from Kratom itself or from contaminants
and adulterants, we will never know.
Overall, the stats are a fairly flimsy basis
for sudden criminalization of a potentially
useful herb, at a time when chronic pain
is rampant, prescription opiate addiction
is out of hand, and side-effects from anti-inflammatory drugs cost the nation $368
million or more every year.
DEA’s attempt to ban Kratom triggered
a massive public outcry—well, relatively
massive, given the obscurity of the plant.
More than 130,000 citizens—
including many military vets and chronic pain
patients—signed a petition to block the
ban. In mid-September, hundreds of Kratom advocates marched in front of the
A surprisingly bipartisan coalition of
more than 50 legislators sent a joint letter
urging the DEA to stand-down. In mid-October the DEA said it was scrapping the
ban, and instead opening a public comment and review period, while awaiting an
FDA analysis of Kratom, prior to making a
final determination about how to regulate
Of note, FDA is currently reviewing an
intravenous opioid drug called Oliceridine
(Trevena) that has some biochemical simi-larities to compounds found in Kratom.
Trevena already has several successful
phase II Oliceridine trials in its portfolio.
Two phase III studies are in progress.
FTC Clampdown on Brain Training
The supplement industry wasn’t the only
sector to feel increased regulatory heat of
late. The Federal Trade Commission has
been going after companies that make
Earlier this year, FTC charged Lumos
Labs—the San Francisco company that
markets the popular Lumosity cognitive
fitness system—with making false and
misleading claims about the system’s ability to improve IQ, stave off age-related
cognitive decline, and restore brain function following stroke.