coffee
Instant coffee sold online
for two years was found to contain an ingredient chemically
similar to Viagra.

Shutterstock/Alpha_7D

On the back of virtually any bottle of supplements, beneath the
bold lettering claiming to list the ingredients, are two words
that strike fear into the heart of Pieter Cohen, a Harvard
Medical School assistant
professor
: “proprietary blend.”

Under the protective umbrella of these words, Cohen said, a
supplement maker does not have to list the details of what’s in
the product.

That is what most likely happened with a type of instant coffee —
sold by the Texas-based vendor Bestherbs Coffee LLC — that the
Food and Drug Administration recently found to contain an
ingredient chemically similar to Viagra.

“Proprietary blend” is essentially a loophole that “allows
companies to put in ingredients without telling us the amounts,”
Cohen said during a panel discussion
organized by the Harvard T.H. Chan School of Public Health. “And
those tend to be the higher-risk product.”

The coffee, sold under the name New of Kopi Jantan
Tradisional Natural Herbs Coffee, was available online
for nearly two years, between 2014 and 2016. But last week, the
FDA announced that the company was voluntarily recalling the
product
 after testing revealed it contained undeclared
ingredients. Desmethyl carbodenafil, in particular,
raised alarms, since it’s chemically similar to sildenafil,
the active ingredient in the popular erectile-dysfunction drug
Viagra.

Bestherbs’ packaging merely says the instant coffee has “natural
herbs.”

The FDA recently oversaw the recall of two other similar coffee
products: Stiff Bull Herbal Coffee and Caverlo Natural Herbal
Coffee. The vendor of each claimed its coffee included an
ingredient derived from the root of a Malaysian tree called
tongkat ali, or “longjack.”

The ingredient is increasingly being used in supplements claiming
to have ”male enhancement” properties. While some limited
evidence
suggests that taking a specific tongkat ali
supplement can improve the quality and concentration of sperm in
infertile men, there is little
evidence to support its use
for erectile dysfunction,
athletic performance, or low testosterone.

The ingredient can also have dangerous side effects, which is why
it’s important for people to know what they are consuming.

According to the FDA, desmethyl carbodenafil can interact
negatively with some prescription drugs by lowering blood
pressure to dangerous levels. Men who have diabetes, high blood
pressure, high cholesterol, or heart disease are at particular
risk.


supplement_proprietary_blend
An
example of the “proprietary blend” label that lets supplements
with potentially dangerous ingredients slip through the
cracks.


Flickr/Mike
Mozart




The ‘proprietary blend’ loophole

To illustrate the problems plaguing the supplement industry,
Cohen likes to compare the safety framework for supplements with
the one we have for food.

Ingredients in food products have to meet a guideline known as
the “generally recognized as safe,” or GRAS, standard.
Ingredients introduced to supplements do not.

Some
laws
regulate dietary supplements, however. In 1994, Congress
passed the Dietary Supplement Health and Education Act to address
the labeling and safety of supplements. Several more recent
regulations mandate that manufacturers observe what is known as
“good manufacturing practices,” including ingredient testing.

But Cohen said those regulations are “not anywhere near the level
of scrutiny” applied to food. A PBS Frontline investigation even
found that the law received investments
from many players
in the supplement industry.

Under the law, manufacturers that list ingredients
under the “proprietary blend” category
don’t have to note
the amounts of individual items in that category.
Instead, they have to list only those within the blend and
the total amount of it. But certain
ingredients are still often left out or mislabeled —
intentionally or not.

The law also allows supplement makers to claim that
a product does
things that it may not
, so long as it says
somewhere on the package that it is “not intended to treat,
diagnose, prevent, or cure diseases.”

If a product is unsafe, then, it becomes the FDA’s
responsibility to prove it. And supplements as a whole
are subject to far less investigation than other
products.

“From a regulatory perspective,” Cohen said, all of these
supplements “are presumed to be safe, but the reality is many
people … are harmed.”