The USFDA has not changed it rules. USFDA has always required Clinical Trials under CFR21 to support an FDA Registration of Infant Formula, called a PER Study. Due to the cost of these trials $3M-$5M, only multinational companies ever registered with USFDA, but anyone could.
The recent "enforcement discretion" from USFDA was a process where the USFDA granted concession ( at their discretion ) on the requirement of Clinical Trials to gain approval. BUBS jumped in ( and paid Joe Hockey $2M to make some phone calls ) and got approved to address the formula shortage.
However - now BUBS must complete the PER Clinical Trials to remain in the US long term. Bye Bye $5M.
The USFDA is simply a rigorous and expensive process, but it's always been open to everyone. It's not biased like China's SAMR.
BUB Price at posting:
19.0¢ Sentiment: Sell Disclosure: Not Held
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