The legal and regulatory status of Carbon 60 (C60), also known as Buckminsterfullerene, is complex and varies depending on its intended use. Here’s a breakdown:

As a Dietary Supplement:

• Lack of FDA Approval: In the United States, C60 is not approved by the Food and Drug Administration (FDA) as a dietary supplement. Dietary supplements do not require FDA approval before being marketed. However, the FDA can take action against supplements that are misbranded or adulterated.   
  
   

   
• Uncertainty Regarding Safety and Efficacy: The FDA and other health authorities emphasize that more research, particularly in humans, is needed to fully understand the safety and potential health effects of C60 as a supplement.   
  
   
• Warning Letters: The FDA has issued warning letters to companies marketing C60 products with claims to treat or prevent diseases like COVID-19, stating that these products are unapproved new drugs and misbranded.   
  
   
• Purity and Quality Concerns: Studies have shown significant variability in the purity and concentration of C60 supplements available on the market, as this category is not strictly regulated. It is advisable to look for products that undergo third-party testing.   
  
   

As a Cosmetic Ingredient:

• Use in Cosmetics: C60 is used in some cosmetic products due to its antioxidant properties, with potential anti-aging effects.   
  
   
• Safety Assessments: Regulatory bodies like the Scientific Committee on Consumer Safety (SCCS) in Europe have assessed the safety of fullerenes, including C60, for use in cosmetics. However, concerns regarding potential genotoxicity and accumulation in organs have been raised, leading to the conclusion that more data is needed to ensure their safety in cosmetic products.   
  
   

General Scientific/Industrial Use:

• Research and Development: C60 is widely used in research and development for various applications, including electronics, materials science, and drug delivery systems. Products intended solely for research purposes typically do not fall under the same strict regulations as those for consumption or cosmetic use.   
  
   
• Industrial Applications: C60 and its derivatives have applications in areas like lubricants, water purification, and carbon capture. These uses are subject to relevant industrial and environmental regulations.   
  
   

Key Considerations:

• Purity and Solvent: The safety and effects of C60 can be significantly influenced by its purity and the solvent in which it is dispersed (e.g., olive oil). Some studies suggest potential light-dependent toxicity when C60 is in certain oils.   
  
   
• Nanomaterial Concerns: While a single C60 molecule is technically smaller than the definition of a nanoparticle, concerns related to the potential toxicity of nanomaterials have been raised regarding C60 aggregates.
• Ongoing Research: Research into the potential benefits and risks of C60 is ongoing, and the regulatory landscape may evolve as more scientific evidence becomes available.

In summary, while C60 is available in some consumer products like dietary supplements and cosmetics, its legal and regulatory status is still evolving, with health authorities emphasizing the need for more research to ensure safety and efficacy. It is crucial for consumers to be aware of the limited regulatory oversight in some of these areas and to consult with healthcare professionals before using C60 products.