The FDA's new "best practices" guidelines are written by the FDA in response to a Congressional bill that was passed in 2005. (The bill was called the Male Sex Enhancement Act.) The bill, which included a mandate that all companies that manufacture and distribute sex hormones should make it very clear that their products are safe and effective for men. The FDA didn't take the bill's bill very seriously, and the FDA doesn't need to act on it, or even make that information public, because there is no "federal law" to which the FDA could apply to regulate the sale of sex hormones, since sex hormones are classified as dietary supplements. However, the FDA has now been pressured to respond to the bill in order to "protect the public." FDA's "best practices" guidelines : " The Food and Drug Administration's position on products for male enhancement and male enhancement therapy is that they are safe and effective for their intended purpose. As a result, these products have been approved by the FDA for use in the United States." In the last 20 years, I have used more than 40 different forms of testosterone for both my own personal and medical use. I don't believe that any of these supplements can be considered safe and effective for men for that purpose alone.