Posted May 30, 2015

Seller of Omega-3, Probiotics & SuperFoods Warned for Manufacturing Violations, Drug Claims

On May 4, 2015, the FDA issued a warning letter to Dr. Dennis Black, LLC., following a facility inspection which found the company's products, including Superfood Single, SuperFood Single Powder, Superfood Double Capsules, Superfoods Family Capsules, Superfood Family Powder, Grab-N-Go Daily, Cleansing Combo Pak, Supersilver Solution, Royal Tea, Omega Oil 3,6,9, Probio Boost, CleanseMax, ParaMax Cleanse and Heavy MetalMax 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 product specifications for the identity, purity, strength, and composition for each dietary supplement and failure to establish specifications for the packaging and labeling of the finished dietary supplements, as required by federal regulations.

In addition, statements made about these products on the company's websites were found to be drug claims. For example, Omega Oil 3,6,9 was promoted with statements such as "Increased levels of Omega 3 and 6 have been shown to have a suppressive effect on cardiovascular disease, cancer, inflammatory and autoimmune diseases, rheumatoid arthritis, and asthma."  

(See ConsumerLab.com's Reviews of Fish Oil and Omega-3 Fatty Acid Supplements for tests of related products.)

Probio Boost was promoted with statements such as "[P]robiotics can be used to improve disease prevention.

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

Superfood Family Powder was promoted with statements such as "[H]ELPS WITH DIABETES," and "My allergies are less severe after being outdoors."

See ConsumerLab.com's Reviews of  Greens and Whole Foods Powders and Pills 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.