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Patients must be clearly informed of the risks associated with nonFDA-approved products, including potential contamination, inaccurate dosing, variable bioactivity, and the presence of impurities that may provoke adverse or unpredictable effects

PMID: 16928994 Loeys BL, Chen J, Neptune ER, Judge DP, Podowski M, Holm T, Meyers J, Leitch CC, Katsanis N, Sharifi N, Xu FL, Myers LA, Spevak PJ, Cameron DE, De Backer J, Hellemans J, Chen Y, Davis EC, Webb CL, Kress W, Coucke P, Rifkin DB, De Paepe AM, Dietz HC

J Hazardous Materials

Basically, this is just a do-over or reevaluation for these substances to place them in the right category