Posted February 20, 2013

Cold, Flu and Stress Supplement Company Warned For Adulteration, Drug Claims And More

On October 5, 2012, the FDA issued a warning letter to dietary supplement manufacturer Wholistic Herbs, Inc. following a facility inspection which found the company’s products, including At-Ease, Morning Calm, Aller-Ban, Stomach Flu, Kold & Koff, Kold Sore, and L. Calming Spirit, were adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to prepare a batch production record each time a batch of dietary supplements was manufactured, and failure to establish and follow written procedures for quality control operations.

At-Ease, Aller-Ban, Stomach Flu, and Morning Calm were also found to be misbranded due to failure to identify the products as dietary supplements on the labels, failure to provide a domestic address or phone number on the labels, failure to include capsule ingredients in the ingredients list, and failure to list botanical dietary ingredients in the proper order and with information about amounts per serving.

Additionally, statements made about At-Ease on the company's website, such as, "We offer herbal alternatives to depression, ADHA, insomnia, arthritis ..." were found to be drug claims.

At Ease was described on the company's website as a "non-addictive, all natural, herbal formula to combat emotional problems and may aid in general well-being.

(See ConsumerLab.com’s Review of Valerian Supplements for tests of related products.)

Koff & Kold spray with herbal extract is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose, and sinus infection. Kold Sore spray with liquid sea mineral is intended to be sprayed into the eyes for the treatment of dry eye and pink eye. The product is also intended to be sprayed into the nose for sinus allergy by pollen, and onto the lips and genitals for the treatment of fever blisters, shingles and herpes simplex.(See product images here.)

Wholistic Herbs recalled Kold & Koff and Kold Sore sprays in February 2012 after confirming that these products were not properly tested for safety and were not sterile. The company had informed the FDA on January 24, 2012 it would discontinue these two products as well as L. Calming Spirit, and would rename the product Stomach Flu.

(See ConsumerLab.com's Encyclopedia of Natural Products article on Colds and Flus for more information and Reviews of Zinc Supplements, Echinacea Supplements, and Vitamin C Supplements for tests of related products.

The FDA's warning letter requests that the company submit copies of the renamed Stomach Flu product label to the agency.

See Related Warnings:

Herbal Sprays for Colds and Cold Sores Recalled

For more information about the FDA's warning letter, use the link below.