Contentious Weight Loss Drug Not Natural Warns FDA

weight loss

A contentious ingredient often hidden in weight loss drugs is in the spotlight again as the FDA begins to clamp down on makers of weight loss drugs who claim that the ingredients they are using are natural; and thereby, allowable by law. Here is what the FDA found with a listing of specific products, plus their cover names that you should watch out for in your weight loss supplements.

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In a recent study, researchers expressed concern over discovering that of 21 weight loss supplements tested, 11 were found to contain an amphetamine-like drug called “BMPEA” that health authorities fear could cause serious health effects like drug addiction, stroke and/or a heart attack.

BMPEA is believed by some in the supplement industry to aid weight loss and is reputed to be a “natural” compound found in a plant called Acacia rigidula―also known as “Vachellia rigidula” or “Blackbrush Acacia”―a shrub native to Texas and Mexico.

However, a recent analysis made by FDA chemists determined that BMPEA was not present in multiple plant samples of Acacia rigidula tested. Therefore, BMPEA is not “natural” as advertised and thereby puts its makers at fault of illegally misbranding their weight loss products by claiming BMPEA as a dietary supplement.

According to a statement made by the FDA:

“While BMPEA was listed as a dietary ingredient on the product labels, the substance does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement. Additionally, relating to the two companies that identified the botanical Acacia rigidula as the source of the BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula. FDA considers these specific products to be misbranded for this reason, as well.”

Weight Loss Supplement Makers Cited

The FDA sent warning letters to the following makers, specifically listing product names of weight loss supplements accused of being misbranded:

Hi-Tech Pharmaceuticals, Inc. (Products: Fastin-XR (extended release), Fastin-RR (rapid release), Lipodrene (Ephedra Free))

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Tribravus Enterprises, LLC d/b/a iForce Nutrition (Products: Conquer (Fruit Punch Slam & Raspberry Lemonade flavors))

Train Naked Labs LLC (Products: Critical FX, Sudden Impact)

Better Body Sports, LLC (Product: Phoenix Extreme)

Human Evolution Supplements, Inc. (Product: Core Burner)


In addition, the FDA also warned consumers that they should avoid products containing BMPEA that may be listed under the following cover names on their labels:

• βMePEA
• R-beta-methylphenethylamine
• R-beta-methylphenethylamine HCl
• Beta-methylphenethylamine
• β-methylphenylethylamine’
• 1-amino-2-phenylpropane
• 2-phenylpropan-1-amine
• 2-phenylpropylamine
• alpha-benzylethylamine
• 1-phenyl-1-methyl-2-aminoethane
• beta-methylbenzeneethanamine
• beta-phenylpropylamine
• 2- phenyl-1-propanamine

According to the FDA’s website, the aforementioned companies have 15 business days from the date of receipt of their letter to contact the FDA and state the specific steps they will take to bring their products into compliance with the law.

For more about weight loss drugs you should be wary of, here is one recently reported to have caused the untimely death of a weight loss supplement user.

Reference: U.S. Food and Drug Administration― “BMPEA in Dietary Supplements

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Comments

Imagine! Using unnatural ingredients! Don't they know only BIG PHARMA and MODERN MEDICINE are allowed to do that?
At least you know what you're getting!
According an extremely comprehensive and well-documented report, conventional medicine is now the #1 cause of death, followed by heart disease (700 000) & cancer (555 000). 783,936 deaths per year cited in the report is short of the real number ... and 2.2 million reports of disability and chronic suffering due to those toxins is also likely far sort of reality. And 1 death is reported (?) to be caused by a weight loss supplement! Wow. At least, with modern medicine you know what killed you!
That's because there is documentation. There is not good documentation about how many deaths are caused by alternative therapies. It's an imperfect system and health care consumers have to take responsibility for asking questions, understanding their options and more. There is a place for each - conventional and alternative therapies for helping people. It is not all one or the other.
According to health and nutrition expert Dr. Gary Null, deaths associated with use of dietary supplements or alternative medicine are extremely rare compared to the death toll from the medical errors and prescription drugs. Even though deaths caused by alternative medicine is extremely rare, an Australian surveillance study that found alternative medicine had caused the death of four children between the years of 2001 and 2003. A total of 39 reports of (non lethal) side effects attributable to the use of alternative medicine were also found. When you compare that to the death statistics of modern drugs, the answer to our conversation becomes rather self-evident. Adverse drug reactions – 106,000 deaths/year Medical errors – 98,000 deaths/year Unnecessary procedures – 37,136 deaths/year Surgery – 32,000 deaths/year Keep in mind also that modern medicine is based on suppression of symptoms while alternative medicine is usually based on the cause of disease. If you find a cause of symptoms, and eliminate that cause, disease has been overcome.
Well sure! Gary Null sells supplements. :)
Hopefully this will lead other doctors to follow suit. Dr. Singh of the Stanford University of Medicine reviewed the records of 11,000 arthritis patients at 8 participating institutions. He extrapolated that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications (internal bleeding) and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures for all NSAID users would be overwhelming, yet the scope of this problem is generally under-reported. The findings from the First Surgical Second Opinion Program found that 17.6% of recommendations for surgery were not confirmed. The House Subcommittee on Oversight and Investigations extrapolated these figures to estimate that, on a nationwide basis, there were 2.4 million unnecessary surgeries performed annually resulting in 11,900 deaths at an annual cost of $3.9 billion. I'll take Dr Null's medicine anytime!