The Food and Drug Administration has a new policy that takes on risky common homeopathic remedies. It will implement severe measures to restrict the sale of some homeopathic products that can be harmful to the public.
The risk-based approach will regulate homeopathic treatments that protect the public from using dangerous products. In a statement, the FDA said:
“Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988.”
Infant and children’s products that contain ingredients associated with some concerns are affected. These products include components, like belladonna and nut vomica. Products that are promoted to treat serious conditions, like heart disease and cancer, will be subject to the new policy.
The concerns about the increasing number of ineffective, harmful products marketed as homeopathic prompted the agency to take additional regulatory actions. It will be consistent with the current enforcement policies.
What is homeopathy?
It is an ancient practice developed in the 1700s. The method is based on two principles. The use of a substance, which can cause symptoms in a healthy person, and diluted to treat an illness. The more diluted it is, the more powerful it becomes. These drugs are prepared using plants, minerals, human and animal excretions.
You can find these products in a retail store, pharmacy and online.
Although not all homeopathic products are harmful, critics are concerned about those that have been contaminated with dangerous substances, which are sold and marketed to treat a serious condition.
In the past, the FDA has already issued warnings about those products. In fact, the Federal Trade Commission required products to be labeled appropriately as homeopathic.
However, the drug market in this industry has grown exponentially into a nearly $3 billion industry in the US alone. As the market increases, the increasing safety concerns also grow. Hence, the FDA summoned a public hearing to talk about a 1988 decision, which did not regulate homeopathic products the same way it controls standard medical treatments.
The FDA respects that some people want to use these alternative treatments. However, it clarified that the agency has a responsibility to protect the public against products that will not provide benefits, rather they can cause harm.
The FDA officials stated that it does not require most homeopathic products that are already on the market to undergo an FDA review. It also emphasized that it will not remove most homeopathic products. Hence, you can still access those homeopathic products that you think have helped you heal.
The proposed policy is not yet final. It will still review comments within 90 days. The long-term critics of homeopathic industry praised the agency’s decision. According to them, it is about time for the FDA to step in to ensure that those snake oil salesmen would be held accountable for their products.