The FDA has issued an urgent warning to not consume, sell or distribute Addall supplements after testing showed the products contained dangerous illegal and undeclared ingredients.
The warning applies to orange-flavored Addall XR shot and Addall XL 30 capsules products, both of which are distributed by ZMB Enterprises, LLC.
They are frequently sold at gas stations and convenience stores, as well as online.
The products claim to provide ‘professional-grade mental clarity for the high-performer,’ according to the company’s website, enhancing concentration and supplying ‘explosive energy.’
However, FDA testing of online retail samples of the products revealed they contained unregulated ingredients that are illegal and unapproved food additives.
The ingredients pose a high risk of addiction and life-threatening cardiovascular complications.
The FDA informed ZMB Enterprises, LLC of the test results in January and recommended a recall of both products. The company agreed to issue a recall of only the shot supplement and refused to recall the capsules.
The company then informed the FDA it would no longer use the unapproved ingredient in its products.
The warning applies to orange-flavored Addall XR shot (shown above) and Addall XL 30 capsules products, both of which are distributed by ZMB Enterprises, LLC
The Addall shot claims to deliver ‘fast-acting, clean focus experience.’
It is a 2-ounce shot with a ‘nootropic blend designed to support mental clarity, sustained energy, and sharper focus without the crash.’
The company claims the product contains caffeine, paraxanthine, and theobromine for alertness, L-theanine to sustain calm focus, Alpha-GPC to enhance cognitive performance, and N-acetyl L-tyrosine ‘to help with motivation under pressure.’
One hundred percent caffeine free, the XL capsules claim to support ‘optimal neurotransmitter activity – helping your brain power through hours of deep focus without the crash.’
It contains 1-Amino-2-phenylethane (PEA), which supports mood and motivation and a ‘fast-acting mental drive,’ Gamma-aminobutyric acid (GABA) for relaxation and calmness and to help ‘balance overstimulation from stimulants,’ and 2-Amino-6-methylheptane (DMHA), which provides mental energy and alertness, along with enhanced focus and ‘performance intensity.’
It is meant to be taken one capsule at a time.
The FDA said earlier this month that testing confirmed the orange-flavored shot contained Phenibut (β-phenyl-GABA), which is unlawful for use in products. It is a central nervous system depressant sometimes used in other countries to treat anxiety and insomnia.
In the US, it is unregulated and poses a high risk of addiction and severe withdrawal.
FDA testing of the product also discovered it contained undeclared 1,4-DMAA (1,4-dimethylamylamine), a synthetic stimulant.
The FDA considers 1,4-DMAA an illegal, unapproved food additive. It has safety concerns including acting as a vasoconstrictor and catecholamine-releasing agent and raises the risk of high blood pressure, rapid heartbeat, stroke, and cardiovascular damage.
The warning applies to orange-flavored Addall XR shot and Addall XL 30 capsules (shown above) products, both of which are distributed by ZMB Enterprises, LLC
The products are frequently sold at gas stations and convenience stores, as well as online (file photo)
Meanwhile, the 2-Amino-6-methylheptane (DMHA) found in the capsules is also an unlawful ingredient in dietary supplements. They also contained undeclared 1,4-DMAA (1,4-dimethylamylamine).
The FDA notice stated: ‘DMAA and DMHA can elevate blood pressure and could lead to cardiovascular problems, including shortness of breath, tightening of the chest, and even heart attack.
‘Phenibut can cause neurocognitive side effects including the development of poor balance, fatigue, and diminished or loss of consciousness.’
Additionally, phenibut has a risk of potential addiction, ‘possibly developing after using the product only a few times,’ the FDA continued.
Then, upon stopping use of phenibut, there is a potential for dangerous withdrawal symptoms.
‘Consuming phenibut, especially in higher doses, could also lead to life-threatening complications if it is used in combination with other substances (prescribed or illicit),’ the FDA notice added.
The FDA notice did not state whether or not illnesses have been reported in connection to eh products.
The agency advised consumers to immediately stop using the products and throw them away. IT also said retailers and distributors should not sell or distribute the products.
Additionally, wholesalers and distributors should cease further distribution and notify their customers of the risks.
Anyone who believes they’ve been sickened by the products should contact a doctor immediately to report their symptoms and receive treatment.
