Group A Streptococcus and the FDA

Suprisingly, the FDA wants to remove restrictions on Group A streptococcus organisms and derivatives in your food and medicines. In the Friday, April 21, 2006, Federal Register a Final Rule was posted that "removes the regulation applicable to the status of specific products; group A streptococcus."

The regulation, 21 CFR 610.19, is deemed "obsolete and a perceived impediment to the development of Group A streptococcus vaccines."

What does this regulation state? Read below:

The presence of Group A streptococcus organisms and derivatives of Group A streptococcus in Bacterial Vaccines and Bacterial Antigens with “No U.S. Standard of Potency” may induce dangerous tissue reactions in humans. Available data demonstrate that they are unsafe as ingredients in products for human use. Group A streptococcus organisms and derivatives of Group A streptococcus are prohibited from Bacterial Vaccines and Bacterial Antigens with “No U.S. Standard of Potency.” Any Bacterial Vaccine or Bacterial Antigen with “No U.S. Standard of Potency” containing Group A streptococcus organisms or derivatives of Group A streptococcus in interstate commerce is in violation of section 351 of the Public Health Service Act (42 U.S.C. 262).

What can happen? Increased incidence of strep throat and impetigo. But...STSS is possible. Streptococcal toxic shock syndrome [general description] [clinical explanation] is a rare [because of 21 CFR 610.19] but extremely severe illness characterized by hypotension (low blood pressure) and shock. Other symptoms can include renal (kidney) impairment, coagulopathy (abnormality in the blood's ability to clot), adult acute respiratory distress syndrome, rash organ and local tissue destruction. Death occurs in up to 70% of people who develop streptococcal toxic shock syndrome.

Thank you, FDA.