Posted August 20, 2019

Seller of Liposomal Curcumin, Vitamin C & Melatonin Warned for Manufacturing Violations

On August 6, 2019, the FDA issued a warning letter to Let's Talk Health, Inc., which found the company's products, including Cardio Advantage Plus, Urine-Eze, Re-Lev-It, Liposomal Symplex P, Liposomal Vitamin C, Melatonin, Liposomal B-Complex, Liposomal Curcumin, Liposomal Glutathione and VariGone, 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 establish and follow written procedures for the responsibilities of the quality control operations and failure to establish and follow written procedures for cleaning the physical plant and for pest control, as required by federal regulations. Many of the violations were repeat violations from the FDA's previous inspection in 2016.

In addition, certain statements made about the products on the company's website were found to be drug claims. For example, the use of curcumin, an ingredient in the company's Re-Lev-It & Liposomal Curcumin was promoted to reduce inflammation in a blog post titled "Inflammation Triggers Chronic Disease."

(See ConsumerLab.com's Review of Turmeric & Curcumin Supplements and Spices for tests of related products).

The company's Liposomal Vitamin C was promoted with statements such as " The importance of Vitamin C in combating cancer is of paramount importance."

(See ConsumerLab.com's Review of Vitamin C Supplements for tests of related products. Also see our answer to the question, Is liposomal vitamin C (sold as Lypo-Spheric) better than other forms of vitamin C?)

Melatonin and Liposomal B-Complex was promoted to prevent cancer and Alzheimer's disease in a blog post titled "Lack of Sleep Linked to Cancer & Alzheimer's Disease."

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

In addition, many of the products were found to be misbranded because the labeling did not declare the presence of allergens, listed incorrect serving sizes, or had other errors.

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:

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

Seller of Liquid Aloe & Mineral Supplement Warned for Manufacturing Violations

To read the complete recall, use the link below.