FDA WARNING_LETTER - The One Minute Miracle Inc. - August 31, 2015

The FDA issued a Warning Letter to The One Minute Miracle, Inc. following an August 2015 inspection and website review. The FDA determined that products like "Miracle Diet 30" and "Miracle Rock 48" are unapproved new drugs and misbranded drugs under the FD&C Act.

Laboratory analysis confirmed "Miracle Diet 30" contains undeclared phenolphthalein, a known carcinogen and unapproved laxative ingredient. "Miracle Rock 48" contains thiosildenafil, an analog of sildenafil (Viagra's active ingredient), which is a PDE-5 inhibitor. Both products are considered drugs due to their intended use for disease treatment/prevention or affecting body structure/function, as evidenced by claims like "Lose Weight," "Supports Appetite Control," and "MALE SEXUAL ENHANCEMENT." These claims do not conform to dietary supplement structure/function claim requirements because phenolphthalein and thiosildenafil are not nutrients or dietary ingredients.

"Miracle Diet 30" and "Miracle Rock 48" are unapproved new drugs because they are not generally recognized as safe and effective. "Miracle Rock 48" is also a misbranded prescription drug as it contains a PDE-5 inhibitor, requiring practitioner supervision, yet lacks adequate directions for lay use and an FDA-approved application. Both products are misbranded for false/misleading statements regarding safety and