The U.S. Food and Drug Administration (FDA) has issued an urgent public health warning, advising consumers not to consume, sell, or distribute Addall dietary supplements. This directive follows laboratory testing that uncovered the presence of dangerous, illegal, and undeclared ingredients in the products, posing significant health risks.
Affected Products and Distribution
The warning specifically targets two products: the orange-flavored Addall XR shot and the Addall XL 30 capsules. Both items are distributed by ZMB Enterprises, LLC. These supplements are commonly available at gas stations, convenience stores, and through various online retail platforms, making them easily accessible to the public.
Marketing Claims Versus Reality
According to the company's website, Addall products are marketed as providing 'professional-grade mental clarity for the high-performer,' with promises of enhanced concentration and 'explosive energy.' The shot is described as offering a 'fast-acting, clean focus experience' with a nootropic blend for mental clarity and sustained energy. The capsules, advertised as 100% caffeine-free, claim to support optimal neurotransmitter activity for hours of deep focus.
However, FDA testing of samples purchased online revealed a starkly different composition. The products contained unregulated ingredients that are illegal and unapproved as food additives, directly contradicting their marketed safety and efficacy.
Dangerous Ingredients Identified
Laboratory analysis confirmed the presence of several hazardous substances. The Addall XR shot was found to contain Phenibut (β-phenyl-GABA), a central nervous system depressant that is unlawful for use in such products in the United States. Phenibut carries a high risk of addiction and severe withdrawal symptoms, with potential neurocognitive side effects including poor balance, fatigue, and loss of consciousness.
Additionally, the shot contained undeclared 1,4-DMAA (1,4-dimethylamylamine), a synthetic stimulant considered an illegal, unapproved food additive by the FDA. This compound acts as a vasoconstrictor and catecholamine-releasing agent, raising risks of high blood pressure, rapid heartbeat, stroke, and cardiovascular damage.
The Addall XL 30 capsules were also found to contain 1,4-DMAA, along with 2-Amino-6-methylheptane (DMHA), another unlawful ingredient in dietary supplements. The FDA notes that DMAA and DMHA can elevate blood pressure and lead to cardiovascular problems such as shortness of breath, chest tightening, and even heart attack.
Company Response and Recall Actions
In January, the FDA informed ZMB Enterprises, LLC of these test results and recommended a recall of both products. The company agreed to recall only the Addall XR shot and refused to recall the capsules. Subsequently, ZMB Enterprises stated it would discontinue using the unapproved ingredients in its products, but the FDA's warning remains in effect for both items due to ongoing risks.
Health Risks and Consumer Advice
The FDA emphasizes that these ingredients pose a high risk of addiction and life-threatening cardiovascular complications. Phenibut, in particular, may cause addiction after only a few uses and can lead to dangerous withdrawal upon discontinuation. When combined with other substances, whether prescribed or illicit, it could result in life-threatening complications.
The agency has not confirmed any reported illnesses linked to these products but urges immediate action. Consumers are advised to stop using the Addall XR shot and Addall XL 30 capsules immediately and dispose of them safely. Retailers, distributors, and wholesalers should cease sales and distribution, notifying their customers of the associated risks.
Anyone who believes they have experienced adverse effects from these supplements should contact a healthcare provider promptly to report symptoms and seek appropriate treatment. The FDA continues to monitor the situation and may take further regulatory actions to protect public health.
