Posted December 1, 2018

Seller of 5-HTP, Potassium & More Warned for Manufacturing Violations

On September 7, 2018, the FDA issued a warning letter to The Delano Company, Inc. dba LifeLink following a facility inspection which found the company's products, including 5-HTP, MonoDEA (micronized DHEA), DendroMax, Potassium Orotate, and Pregnenolone , 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 failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by federal regulations.

In addition, certain statements made about the products on the company's websites were found to be drug claims. For example, the company's 5-HTP was promoted with statements such as " 5-HTP . . . is the immediate precursor of serotonin. Low levels of serotonin are associated with depression, obesity and sleep disorders "

(See ConsumerLab.com's Review of L-Tryptophan and 5-Hydroxytryptophan (5-HTP) Supplements for tests of related products.)

The company's Potassium Orotate was promoted with statements such as " Potassium Orotate - a supplement with a talent for reversing tissue damage throughout the body, including the brain. … Potassium orotate supplementation has been found to have a variety of applications in such areas as: heart, liver, kidney, and lung damage, wound healing and skin ailments, viral hepatitis, … tuberculosis, diabetes, epilepsy, anxiety, depression, dizziness, and disorientation, bone fractures, dental cavities…."

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

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 ConsumerLab.com's Review of Sexual Enhancement Supplements for tests of related products.

See related recalls and warnings:

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

Seller of Echinacea Warned Manufacturing Violations, Drug Claims

Seller of Vitamin C, Iron and Detox Supplements Warned for Violations, Drug Claims

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

To read the complete recall, use the link below.