Recalls and Warnings
(Date Posted: 10/8/2019)
|Seller of Tea, Colloidal Silver, Homeopathic Products Warned for Manufacturing Violations
On September 12, 2019, the FDA issued a warning letter to Herbal Healer Academy, Inc., which found the company's HHA 4-Herb Tea Bulk and HHA Colloidal Silver, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.
These violations include failure to collect and hold reserve samples of each lot of packaged and labeled dietary supplement and failure to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by federal regulations.
In addition, certain statements made about the products on the company's website were found to be drug claims. For example, its HHA Colloidal Silver was promoted with statements such as "It works very well for multiple sub-clinical infections / allergies. This is a fantastic product and everyone needs colloidal silver in your alternative medicine cabinet."
(See ConsumerLab.com's answer to the question Is ingesting colloidal silver helpful for any condition and is it safe to use?).
In addition, the company's homeopathic products, including Herbal Healer Parasite Detox, Apis Mel, Cantharis, Cataract Drops, Glaucoma Formula, Natrum phos, Homeopathic Parasite Detox, and Sabal Serrulata were found to be misbranded because they were promoted for conditions that are not self-limiting and amenable to self-diagnosis, as outlined in the FDA's Compliance Policy Guide under the section "Conditions Under Which Homeopathic Drugs May be Marketed."
The company is required to notify the FDA in writing of the specific steps taken to correct the violations within fifteen working days of receipt of the warning letter.
See related recalls and warnings:
Seller of Liposomal Curcumin, Vitamin C & Melatonin Warned for Manufacturing Violations
FDA Warns Seller of Reishi, Joint Supplements, Ginseng & More for Pesticides, Other Violations
Seller of Protein Powder, Spirulina & Other Products Warned for Manufacturing Violations
Seller of 5-HTP, Potassium & More Warned for Manufacturing Violations
Seller of Astaxanthin, Cinnamon, Pine Bark and More Warned for Manufacturing Violations
FDA Warns Seller of Joint Health Supplements & More for Manufacturing Violations
Seller of Prostate, Immune Supplements & More Warned for Manufacturing Violations
For more information, use the link below.
Warning Letter: Herbal Healer Academy, Inc.
For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.