Healthcare Practitioner Corner
Holistic Primary Care
Erik Goldman is co-founder and
editor of Holistic Primary Care: News for
Health & Healing, a quarterly medical publi-
cation reaching about 60,000 physicians and
other heathcare professionals nationwide. He
is also co-producer of the Practitioner Chan-
nel Forum, an annual executive level gather-
ing focused on challenges and opportunities
in the health practitioner channel. For more
Whatever else you might think about
Donald Trump’s presidential victory, and
whatever moves the Republicans might
make toward repealing the Affordable
Care Act, it’s a safe bet that regulating the
dietary supplement industry won’t be high
on the new administration’s to-do list.
No doubt a Republican-controlled
Congress is giving many in our industry
cause to breathe a deep sigh of relief.
But nobody should get too comfortable. The spate of federal regulatory
moves over the last six months could
have significant impact on the practitioner channel as well as on the practice of
holistic, functional and integrative medicine in the coming years.
While none of these actions represent
a direct threat to practice freedom or
supplement access, they set precedents
that could greatly limit access to dietary
supplements and other foundational
tools in the practice of holistic and func-
The FDA’s revisions to its New Dietary
Ingredient (NDI) notification process,
published in August, received widespread
coverage in our industry media. If implemented as written, the revised NDI process would “pharmaceutical-ize” supplements, potentially forcing many existing
products off the market, and stifling innovation in the field.
Shortly after issuing the NDI guidelines,
the FDA eliminated vinpocetine—a vasodilator compound derived from Vinca—from
its list of acceptable supplement ingredients. The move sets a precedent for the
quiet“disappearance” of other botanicals.
And then in September, the Drug Enforcement Agency came very close to
banning and criminalizing Kratom (
Mitragyna speciosa), a southeast Asian herb
many chronic pain patients have found
to be a safer, more effective alternative to
prescription pain medications.
Meanwhile, the Federal Trade Commission has moved to squelch brain-training
and cognitive strengthening exercise systems—a development that has no direct
bearing on supplements, but does represent
a relevant lesson from a parallel universe.
It is anyone’s guess how the Trump
administration will deal with FDA, FTC
and other federal regulatory agencies. But
nobody should be resting easy. In the inevitable regulatory lull that will follow the
presidential transition, our industry has an
opportunity to cultivate clinical as well as
NDI System: Protecting Whom?
The FDA’s revised New Dietary Ingredient
(NDI) Notification guidance has significance for anyone in the industry. If implemented as written, the guidelines have
potential to change the regulatory status
of thousands of products.
The basis for the NDI notification system is in the Dietary Supplement Health
and Education Act (DSHEA) of 1994,
which set up the regulatory framework
governing the supplement industry.
Under the law, companies bringing
novel supplement ingredients to market
are supposed to notify the FDA of that
intention. The agency would then review
safety data supporting the ingredients prior to their entry into the market.
FDA sees NDI notification as a preventive control to protect consumers from
exposure to ingredients of unknown
safety. But in the two decades since passage of DSHEA, FDA’s definition of what
counts as “novel” has been vague, as
have the standards of evidence needed to
As a result, industry compliance and
regulatory enforcement have both been
slack. According to FDA, there are 55,600
supplement products already on the U.S.
market, and more than 5,000 new ones
emerging every year. But the agency only
receives an average of 38 NDI notifications per year.
The NDI process, as detailed in the
August guidelines, will allegedly grandfather any naturally occurring compound
provably present in the food supply as a
dietary ingredient or dietary supplement
In the Post-Election Lull,
Cultivate Clinical Allies
Regulatory actions taken over the last six months could have lasting impact on the future
of integrative medicine.
By Erik Goldman