May 1, 2012

FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.
The specific provision that FDA has decided to enforce is the one that says synthetic botanicals will no longer be considered New Dietary Ingredients and must never be sold as supplements, only as drugs. Last Friday, FDA issued a press release and sent warning letters to ten companies who sell supplements containing DMAA (dimethylamylamine), which is advertised to increase energy, concentration, and metabolism. The manufacturer says DMAA is derived from the Asian geranium—specifically, geranium oil.
In their warning letters, FDA said the supplements are technically classed as “adulterated” for two reasons: (1) DMAA has not gone through the NDI notification process, and (2) it is a synthetically produced botanical which, by definition, is not an NDI.
However, the claim that a synthetic botanical is not a dietary ingredient is nowhere to be found in the law governing supplements: the Dietary Supplement Health and Education Act of 1994 (DSHEA). This new distinction comes exclusively from the NDI draft guidance, which is one reason we called it a perversion of congressional intent.
For years drug companies have studied plants for medicinal uses. As we noted recently, if they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance—a new molecule that can be patented and then taken through the FDA as a new drug. With this provision in the NDI draft guidance, FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, natural products cannot be patented while synthetics can, and only patented substances can afford to be brought through the hugely expensive FDA approval process.
The worst part is that FDA is now treating the guidance as if it has been finalized—something they promised not to do. In February, FDA held a meeting with the Natural Products Association (NPA), and explicitly told the group that until FDA finishes reviewing comments and releases final guidance, it would enforce only DSHEA and not the draft guidance. Now they’ve gone back on their word.
In addition, we would point out that FDA has still not addressed the many formal comments that were submitted on the synthetic botanicals question. We, and many others, said that FDA’s claim that synthetic constituents of botanicals are not NDIs while synthetic constituents of any other substance are NDIs is a completely arbitrary distinction. Taking action when they haven’t reviewed any of the thousands of pages in public comments makes a complete sham of the formal comment period. Moreover, FDA shouldn’t be enforcing a guidance when it is still in the draft stages anyway—that’s the point of it being a draft.
Worse, by going outside the bounds of DSHEA, the NDI guidance is basically creating new law, which the FDA is not allowed to do. Instead of issuing proper regulations and going through the formal rulemaking process (as is required when creating a new law), the FDA sidestepped everything by issuing a guidance. Technically, a guidance is not legally binding—which makes lawsuits difficult—but as feared, the FDA is enforcing the guidance as if it were.
DMAA is not without some controversy. Last year, two soldiers died after having heart attacks during fitness exercises, and both happened to be taking supplements that contained DMAA, though as of this writing, DMAA has not been conclusively linked to the deaths. A spokesperson for the manufacturer said that “there have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among people who used the products as directed. Just to be safe, the US Army is investigating, and the Defense Department has removed all products containing DMAA from stores on military bases until the safety review is complete.
If DMAA is proven to be unsafe, it should be removed, plain and simple. If it is a New Dietary Ingredient, then by all means it should go through the NDI notification process as outlined by DSHEA. But let’s just stop this nonsense about it being illegal because it’s a synthetic botanical—that is not a requirement of DSHEA. That requirement comes only from FDA, and it is not supported by law.
Here’s the crux of the matter: If FDA fully enforces this guidance as drafted, we will likely lose between 22,240 and 41,700 nutritional supplements from the market, at an economic loss of between $5.6 billion and $10.5 billion; the nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and between 55,720 and 104,475 jobs in the supplement industry could be lost.
Let’s be clear: this is not about DMAA. This is the FDA setting in motion its draft guidance, which threatens our access to more than half of the supplements we all need to stay and get healthy.

FDA NEWS RELEASE

For Immediate Release: April 27,
2012
Media Inquiries: Tamara Ward, 301-796-7567, tamara.ward@fda.hhs.gov
Trade
Press Inquiries: Sebastian Cianci, 240-402-2291, sebastian.cianci@fda.hhs.gov
Consumer
Inquiries: 888-INFO-FDA

FDA challenges marketing of DMAA products for lack of safety evidence

Agency cites ten companies in warning letters

The U.S. Food and Drug Administration today issued warning letters to ten
manufacturers and distributors of dietary supplements containing
dimethylamylamine, more popularly known as DMAA, for marketing products for
which evidence of the safety of the product had not been submitted to FDA.

Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium
extract, the ingredient is in dietary supplements and is often touted as a
"natural" stimulant.

The companies receiving warning letters and their product names are:

Company Product(s)

Exclusive Supplements1	Biorhythm SSIN Juice
Fahrenheit Nutrition2	Lean Efx
Gaspari Nutrition3	Spirodex
iSatori Global Technologies, LLC4	PWR
Muscle Warfare, Inc.5	Napalm
MuscleMeds Performance Technologies6	Code Red
Nutrex Research7	Hemo Rage Black Lipo-6 Black Ultra Concentrate Lipo-6 Black Lipo-6 Black Hers Ultra Concentrate Lipo-6 Black Hers
SEI Pharmaceuticals8	MethylHex 4,2
SNI LLC9	Nitric Blast
USP Labs, LLC10	Oxy Elite Pro Jack3D

"Before marketing products containing DMAA, manufacturers and distributors
have a responsibility under the law to provide evidence of the safety of their
products. They haven’t done that and that makes the products adulterated," said
Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement
Program.

Specifically, the warning letters cite the companies for
marketing products for which a notification had not been submitted for the use
of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement
manufacturers or distributors who use certain dietary ingredients not marketed
in a dietary supplement prior to October 15, 1994, are responsible for notifying
the FDA of evidence to support their conclusion that their dietary supplements
containing NDIs are safe. Manufacturers or distributors must submit notification
at least 75 days before marketing their products. The companies warned today
were marketing products for which this requirement had not been met.

The FDA warning letters also advised the companies that the agency is not
aware of evidence or history of use to indicate that DMAA is safe. Under the
Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers,
marketers and distributors of dietary supplements are responsible for ensuring
that they are marketing a safe product.

The FDA letters noted that DMAA is known to narrow the blood vessels and
arteries, which can elevate blood pressure and may lead to cardiovascular events
ranging from shortness of breath and tightening in the chest to heart attack.
The agency has received 42 adverse event reports on products containing DMAA.
While the complaints do not establish that DMAA was the cause of the incidents,
some of the reports have included cardiac disorders, nervous system disorders,
psychiatric disorders, and death.

The agency additionally warned the companies that synthetically-produced DMAA
is not a “dietary ingredient” and, therefore, is not eligible to be used as an
active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as
a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for
use by man to supplement the diet, or a concentrate, metabolite, constituent,
extract, or combination of these substances.

The companies have 15 business days to respond to the FDA with the specific
steps they will take to address the issues in the warning letters.

For more information:

How dietary supplements are regulated¹¹

Dietary Supplement Health and Education Act of 1994¹²

New Dietary Ingredient notification process¹³

Reporting adverse events associated with FDA regulated
products¹⁴

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The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements, products
that give off electronic radiation, and for regulating tobacco products