MYA International, Inc.
FDA issued a warning letter to MYA International, Inc. (Chula Vista, CA) after inspecting their facility and reviewing product labeling for nine dietary supplement products (Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea/Tea Cellular, Quiebra Piedras, Shark Cartilage, and Helper). The products' catalog claims established drug intent — including treating diabetes, cancer, bacterial infections, and psychiatric disorders — making them unapproved new drugs and misbranded drugs under the FD&C Act. FDA also cited serious cGMP violations and numerous dietary supplement labeling deficiencies, and warned that failure to correct violations may result in seizure or injunction.
Flagged claims (9)
Natural Antibiotic Qualities.
The antispasmodic activity of the stone crushing alkaloids showed slight muscle relaxation specific to the urinary tract and bile duct, for which the researchers attributed facilities an ease in the expulsion of bladder and kidney stones. MAIN USES: … eliminate obstructions, eradicate stones, reduce inflammation, … detoxify the liver, … reduces blood sugar levels, reduces blood pressure and cholesterol.
It is an exceptional supplement for children who suffer from disorders or hyperactivity, schizophrenia, bipolarity, depression, Parkinson's-like memory problems. It also helps against … insomnia ….
This combination of purifying plant extracts helps identify, gather, and eliminate toxins from the body. It is of great help in the control of: cancer, arthritis, diabetes, allergies, infections, circulatory problems ...reduces pain, inflammation, and joint stiffness
Powerful combination of two formulas designed to help stabilize blood glucose problems and help maintain regulation of your metabolism thereby reducing the need for insulin and helping to regulate blood sugar levels . . .
It is a powerful helper...that inactivates the enzymes of all bacterial cells, fungi, and viruses that are using oxygen for their metabolism, causing them to suffocate in 6 minutes or less. Helps in: parasites, herpes, chronic fatigue, on the skin helps with acne, open wounds, athlete's foot, conjunctivitis or irritations.
Penalin is a direct product of garlic extract. Garlic is known to ward off diseases .... Studies show that garlic fights cholesterol ... lowers blood pressure, is anti-inflammatory, prevents colds, improves asthma.
Has auxiliary qualities as an anti-inflammatory, analgesic …. These properties make it an ally of the treatment of cancer. Contains substances … that help ailments such as lupus and psoriasis.
Helps with infections such as influenza…tonsillitis, flu, and respiratory system conditions. This supplement with natural antibiotic qualities of wide spectrum [sic] is effective against many bacterial processes.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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