FDA WARNING_LETTER - Dr. Dennis Black - March 06, 2014

An FDA inspection of Dr. Dennis Black, LLC. (2387 Midway Road, Carrollton, Texas) from February 26 to March 6, 2014, revealed serious violations of the Federal Food, Drug and Cosmetic Act. The FDA also reviewed the firm's websites, www.drdennisblack.com and www.texassuperfood.com, in August 2014 and January 2015.

The firm's products, including "Superfood Single," "Supersilver Solution," and "Royal Tea," are promoted with therapeutic claims (e.g., "eradicate parasites," "help even cancer," "stimulate rapid healing") and testimonials for treating diseases. This causes them to be unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) and § 321(p), requiring FDA approval (21 U.S.C. § 355(a)). Furthermore, these products are misbranded under 21 U.S.C. § 352(f)(1) because they lack adequate directions for layperson use for conditions not amenable to self-diagnosis.

Even if not unapproved drugs, all dietary supplements manufactured by the firm are adulterated under 21 U.S.C. § 342(g)(1) for failing to comply with