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TITAN SARMS LLC was cited for distributing unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act by selling selective androgen receptor modulators (SARMs)—specifically LGD-4033, RAD-140, S-4, and YK-11—through its website despite marketing them as "research-only" compounds. The FDA determined these products met the definition of drugs intended for human use based on labeling and website claims indicating they affect body structure or function, and identified serious safety concerns including liver toxicity, heart attack risk, and stroke potential. The company's products were introduced into interstate commerce without FDA approval, violating sections 301(d) and 505(a) of the FD&C Act.