FDA Form 483 Warning Letter

US fda warning letter | FDA Form 483 Warning Letter

Despite intensive research, medical science has yet not been able to find cures for certain severe medical disorders such as autism and Alzheimer’s disease. Owing to the seriousness of these disorders, those suffering from them or their caretakers are in desperate search of a cure.

This hope of theirs and their vulnerable state of mind is often misused by companies claiming to produce medicines towards the treatment of these ailments.

The U.S. Food and Drug Administration has given serious warning against over-the-counter sale of chelation drugs vouching to treat medical conditions like autism, heart disease and Alzheimer’s disease.

The companies selling the product claim that these drugs have the ability to eliminate heavy metals from the body, thereby aiding in the cure of these disorders. Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, has firmly debarred the sale of these products as these companies are manipulating a very serious issue.

US fda Warning Letters | Review

The FDA is believed to have given letters of warning to eight companies involved in the sale of unmerited drugs and devices, thus found guilty of violating the federal law.

There are some chelation drugs that have been approved by the FDA to be sold to patients suffering from heavy metal poisoning but only with a prescription. The FDA strongly opposes the sale of these products over the counter or through the Internet.

Administration of such products without medical supervision could change the level of substances in the blood leading to severe repercussions such as dehydration, failure of kidney and even death.

FDA Form 483 Warning Letter

The companies to whom the warning letters have been addressed include World Health Products LLC; Hormonal Health LLC; Evenbetternow LLC; Maxam Nutraceutics/Maxam Laboratories; Cardio Renew Inc; Artery Health Institute LLC; Longevity Plus, and Dr. Rhonda Henry, a nutritionist. The FDA has further cautioned them that incase no rectifications are made; the companies must be prepared to face grave legal consequences.

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