DMSO (dimethyl sulfoxide) faced significant restrictions and a halt in widespread approval primarily because the U.S. Food and Drug Administration (FDA) discovered it caused serious eye problems in test animals during studies conducted in the early 1960s.
The Core Reason for Restrictions
In the early 1960s, the United States Food and Drug Administration initiated testing on DMSO due to its emerging popularity and anecdotal claims of various therapeutic benefits. However, these tests were abruptly halted when researchers observed alarming side effects. The use of DMSO was found to cause serious eye problems in the test animals, leading the FDA to immediately stop further investigation into its broader medical approval and effectively restrict its general use.
A Closer Look at DMSO's Regulatory History
Early Promise and Sudden Halt
DMSO gained considerable attention in the mid-20th century, hailed by some as a "miracle drug" for its perceived anti-inflammatory, pain-relieving, and remarkable skin-penetrating properties. Its ability to rapidly pass through skin and deliver other substances into the body made it a subject of intense research and public interest. However, the FDA's discovery of ocular toxicity in laboratory animals critically impacted its trajectory for widespread medical application.
Specific Concerns Identified
The primary concern that led to the severe restrictions on DMSO was:
- Ocular Toxicity: The most critical finding was that DMSO caused changes in the lens of the eyes in test animals. This raised fears of permanent vision damage, including the potential for cataracts, in humans. This direct threat to a vital organ prompted immediate regulatory action.
- Permeability Issues: While a beneficial property for delivery, DMSO's ability to easily penetrate the skin also meant it could carry impurities or other chemicals present on the skin or in the product itself directly into the bloodstream, posing additional unforeseen risks.
- Unpleasant Side Effects: Users often reported a distinctive garlic-like body odor and taste, as well as skin irritation at the application site, although these were less critical to the "ban" than the eye concerns.
Is DMSO Still Banned? Current Status
While the term "banned" suggests complete prohibition, DMSO is not entirely banned for all uses. Instead, its use in humans is highly regulated and restricted to specific, FDA-approved applications due to the initial safety findings.
Currently, there is one FDA-approved medical use for DMSO:
- Interstitial Cystitis: A specific pharmaceutical-grade formulation of DMSO is approved for the symptomatic relief of interstitial cystitis (also known as bladder pain syndrome), administered directly into the bladder via a catheter. This highly controlled application minimizes systemic exposure.
For any other medical conditions, DMSO remains an unapproved drug for human administration by the FDA. Non-pharmaceutical grade DMSO is widely available as an industrial solvent or research chemical, but using these products on humans carries significant health risks due to impurities and lack of quality control.
Key Regulatory Milestones
The journey of DMSO through regulatory scrutiny highlights the critical role of agencies like the FDA in safeguarding public health.
| Year (Approx.) | Regulator | Action | Reason |
|---|---|---|---|
| Early 1960s | US FDA | Halted widespread approval & testing | Discovery of serious eye problems in test animals |
| 1978 | US FDA | Approved specific medical use (Rimso-50) | For symptomatic relief of interstitial cystitis |
For more detailed information on health supplements and products like DMSO, reputable sources such as the Health Canada website and FDA drug labels offer valuable insights.
