Development of probiotics as biologic drugs.
In the United States, probiotics that are intended to be used to diagnose, cure, mitigate, treat, or prevent disease in humans or other animals and that affect the structure or the function of the body are considered to be drugs. This article provides a brief overview of the historical basis of US regulation of drugs and biologics and explores the legal, regulatory, and policy considerations for probiotics as biologic drugs for humans.
Hoffman
Freddie Ann
FA
HeteroGeneity, Washington, DC 20011, USA. fhoffman@heterogeneity-LLC.com
D000818:Animals; D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D017277:Drug Approval; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products