Posted September 14, 2016

Seller of Aloe, Prostate and Joint Supplements Warned for Manufacturing Violations

On April 8, 2016, the FDA issued a warning letter to Salud Natural Entrepreneurs, Inc., following a facility inspection which found the noni juice products sold by the company, including Aloe Vera Juice, Urinary System Tea, Nopalina Flax Seed Plus Fiber Powder and Capsules, Urcran Cranberry, Aloe Vera With Nopal Juice, Aloe Vera With Nopal And Grape Juice, Aloe Vera Gel, Cardio Support, Fat Burner, Liver Support, Prostate Support, Triple Potency, Uro-Max Formula, Arthritis Formula, Diabetes Formula, Sinusitis Bronchitis Capsules, Urinary System Tea, Respiratory System Tea, Obesy-Tea, Blood Purifier Tea, Diabetes Kit, and Overweight and Cholesterol Kit to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

The company failed to establish the required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by federal regulations. 

In addition, statements made about the company's products on labels and its website were found to be drug claims. For example, its Aloe Vera Juice was described as "Analgesic" and "Anti-Inflammatory." Prostate Support was promoted with statements such as "Used for: Hypertrophy or prostate enlargement, prostate infections, urinary difficulties, pain upon urination frequent urination," and Arthritis Formula was promoted with statements such as "Used for: Sciatic Pain, Osteoarthritis Pain, Arthritis, Low Back Pain, Neck Pain, Rheumatism, Shoulder Pain Knee Pain and Hip Pain."

See ConsumerLab.com's Reviews of Aloe Supplements, Prostate Supplements and Supplements for Joint Health for tests of related products.

See Related Warnings:

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Seller of Turmeric, Milk Thistle and More 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

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