Posted November 7, 2015

Seller of "NaturalDoctor" Vitamin C, Echinacea and More Warned for Manufacturing Violations

On October 16, 2015, the FDA issued a warning letter Sound Healing Arts, PC, dba Grounds for Tea, LLC, following a facility inspection which found the company's products, including  NaturalDoctor Vitamins C & K3, NaturalDoctor Goldenseal & Echinacea Plus, NaturalDoctor Centella Skin and Veins, NaturalDoctor Organic Artemisia Plus, NaturalDoctor Organic Dong Quai Plus, NaturalDoctor Organic Dandelion Plus, NaturalDoctor Vitex PMS and NaturalDoctor St. John's Mood Plus to be adulterated because they prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish and follow written procedures for the responsibilities of the quality control operations and failure to establish written procedures for maintaining, cleaning, and sanitizing equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by federal regulations.

In addition, statements made on product labels and on the company's websites were found to be drug claims. For example,  NaturalDoctor Vitamins C & K3 was promoted with statements such as "This remedy treats a variety of malignancies ...including: ...Breast ....Cervix ...Colon ...Liver ...Oral Squamous Cell ...Nasopharyngeal ...Prostate ...Stomach ...Testicals ...Urological (Kidney, Transitional & Squamous Cell Bladder, & Androgen-Independent Prostate) ...Uterine ...Adriamycin ...Leukemia ...Lymphoma." 

(See ConsumerLab.com's Reviews of Vitamin C Supplements for tests of related products.)

NaturalDoctor Goldenseal & Echinacea Plus was promoted with statements such as "Benefits: Acute or chronic mucous membrane conditions: common cold, sinusitis, bronchitis, tonsillitis, chronic constipation, ...diarrhea and cystitis."  

(See ConsumerLab.com's Review of Echinacea Supplements for tests of related products.)

NaturalDoctor St. John's Mood Plus was promoted with statements such as " Proven by numerous trials to be as effective in aiding mild to moderte depression as Paxil, Zoloft and Prozax [sic] with virtually no side effects.

See ConsumerLab.com's Reviews of St. John's Wort Supplements for tests of related products.

See Related Warnings:

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

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