FDA Cracks Down on False Claims about Autism Treatments

Date: 
April 30, 2014
Agency issues consumer warning; threatens legal action against those who market unproven, potentially dangerous products and therapies


The Food and Drug Administration (FDA) has issued a new consumer bulletin, “Beware of False or Misleading Claims for Treating Autism.”

“There is no cure for autism,” the bulletin states. “So products or treatments claiming to ‘cure’ autism do not work as claimed. The same is true of many products claiming to ‘treat’ autism. Some may carry significant health risks.”

“Autism Speaks and its many partners are working diligently to find treatments for autism that are safe and effective,” comments developmental pediatrician Paul Wang, Autism Speaks senior vice president and head of medical research. “We know that parents often are desperate to find help for their children. It’s tragic when unscrupulous companies take advantage of these families by pushing so-called treatments that are not only ineffective, but may be costly and dangerous.”

Though behavioral therapies don’t cure autism, research has demonstrated that several such programs can bring about real improvements in development and function, Dr. Wang adds. In addition, the FDA has approved two medications – risperidone and aripripazole – to treat severe self-injurious behavior and aggression associated with autism. These medications can have serious side effects and, so, are reserved for situations where behavioral approaches fail.

The new FDA statement notes that the agency has issued warnings of legal action against several companies marketing unproven and potentially dangerous products and treatments for autism. They include:

Chelation therapies come in the form of either over-the-counter products or prescription treatments. They are designed to remove minerals and metals from the body. As medical treatments, they are generally reserved for severe cases of lead or iron poisoning. As an autism cure, they are claimed to work by cleansing the body of toxic chemicals. The most serious side effects include life-threatening mineral deficiencies.

Hyperbaric oxygen therapy involves breathing concentrated oxygen in a pressurized chamber. Dangers include seizures associated with excess oxygen in the blood and central nervous system.

Miracle Mineral Solution (MMS) is a potentially caustic substance. The FDA has received reports of consumers experiencing severe nausea, vomiting and low blood pressure after drinking the product.