Posted May 3, 2013

Homeopathic Company Warned For Drug Claims and Improper Labeling

On March 12, 2013, the FDA issued a warning letter to Natural Medicine Associates, Inc. following an inspection of the company’s label distribution center which found statements made on the company’s labels and marketing materials about ASTHMA H12, COLD SORES H16, ECZEMA H23, RHEUMATIC PAIN H57, EYE IRRITATION H25, FEVER & INFECTION H27, ACNE H11, FLU H28, PROSTATE H39, CHICKEN POX H72, EARACHE H77, FEVER AID H78, PHOBIA & ANXIETY H56, ROSACEA & REDNESS RELIEF H58, and MEASLES H80 to be drug claims.

For example, ASTHMA H12 was described as “Helpful in the case of breathing difficulties with no cough, such as . . . mild bronchitis.” Statements made about FLU H28 included “Helps prevent . . . flu symptoms and the aches and pains that accompany the flu . . . Also helpful for intestinal troubles.” PROSTATE H39 was promoted “To relieve symptoms of prostate swelling and discomfort with frequent urination.”

These products are identified in the company’s marketing materials as homeopathic drugs, which may be manufactured and distributed without FDA approval if they meet certain criteria. However, the labels for these products do not meet these criteria because they failed to include active ingredients measured in homeopathic strengths and fail to use ingredient names as specified in the Homeopathic Pharmacopeia of the United States.

These products were also found to be misbranded because the labels do not provide adequate directions for use.

See ConsumerLab.com’s Encyclopedia of Natural Products articles on Homeopathy and specific homeopathic treatments for Asthma, Flu and other conditions for more information about the ingredients used in these products.

See ConsumerLab.com’s Reviews of Echinacea Supplements and Prostate Supplements for tests of related products.

To read the FDA’s warning letter, use the link below.