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I invoked herbal dietary supplements as an example where the FDA cannot demand prospective safety and efficacy testing, as with prescription and OTC drugs, because of the 1994 Dietary Supplement Health and Education Act. With these products, the FDA has only two general options protecting consumers.? If the marketed product proves unsafe and adverse reactions are reported, the FDA can pressure the company to issue a product recall and confiscate unsold product. If the manufacturer markets the product to prevent, treat, or diagnose disease, the FDA can cite the product as an ???unapproved drug??? and order the immediate cessation of sales.