In 1988, the FDA enabled drugs labeled as homeopathic to be produced and distributed without the agency’s approval. But based on this new amendment to the original policy, the agency intends to use its enforcement powers on a product they deem potentially dangerous. Homeopathic treatments aimed at vulnerable populations such as children or the elderly, as well as those that make claims about life-threatening conditions, will come under closer scrutiny.

New Risk-Based Enforcement

In a statement, the FDA described this as, “A new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits.”

The revised FDA proposal will be monitoring the industry and investigating some of the following priority situations:

  • Safety concerns that have been reported by consumers and medical professionals
  • Ingredients that are known to present safety concerns
  • Products other than those taken orally or topically
  • Products touted as prevention or cure for serious and/or life-threatening conditions, such as cancer and heart disease
  • Products marketed to vulnerable populations
  • Products that do not meet standards of homeopath quality, strength or purity as required under the law

Homeopathy in the United States

There has been dramatic and steady growth in the homeopathic market, which is estimated to be close to a $3 billion industry. The formerly less stringent controls have allowed the industry to flourish, and there are many products on the market that consumers find beneficial.

Despite the general disapproval of allopathic medical doctors, some patients find relief with homeopathic treatments, which come in a range of different forms, such as pellets, tablets and tinctures that are placed under the tongue or on the skin, where they are absorbed into the system.

Homeopathic medicine has been around for a long time, but it is more common in countries that are partial to holistic approaches. A recent study from Harvard found that use of homeopathy in the U.S. is lower than in many European countries.

The researchers also found that people who’d seen a professional homeopathic doctor have a more positive view of homeopathic medicine than those who’d self-treated with over-the-counter products. The connection to a homeopathic doctor who prescribed medicine made the remedies more of a priority in a person’s life.

Alternative Rehab Therapies

The field has grown over time to include homeopathic addiction products for people struggling with drug cravings, but not all have been found to have proven benefits, nor are they all administered by experienced health professionals. Consumers should always educate themselves and conduct their own research, and seek qualified addiction specialists when considering alternative rehab therapies.

Keep in mind that detox from alcohol and drugs requires medical supervision and shouldn’t be attempted without proper medical support. Products that claim to cure addiction or promise to end cravings should never be taken without a doctor’s approval.

Research has shown that people struggling with addiction benefit from a multidisciplinary approach and alternative rehab therapies should be guided by professional. Addiction recovery often requires a support system of medical and mental health professionals, as well as being part of a community of like-minded people in recovery such as Alcoholics Anonymous. These things cannot be found in any one product on the market.



“FDA Proposes New, Risk-based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs” – U.S. Food and Drug Administration

“FDA Plans Crackdown Homeopathic Medicine Geared Tow Children with Cancer” – U.S. Today

“FDA Crackdown on Sake Oil Homeopathy” – NBC News

“FDA Targets Risky Alternative Medicine” – Fortune

“Harvard Study Has Good News For Homeopathic Medicine” – Integrative Practitioner

“British Homeopathic Association” – British Homeopathic Association

“Homeopathy Use by US Adults: Results of a National Survey” – NCBI

“Submit a Report or Complaint About a Product” – U.S. Food and Drug Administration


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