Posted October 6, 2020

FDA Warns Seller of Red Yeast Rice, Vitamin D, Blood Pressure Supplements, and More

On August 28, 2020, the FDA issued a warning letter to Dr. Sam Robbins, Inc. dba HFL Solutions, LLC following a review of the company's websites, which found statements made about some of the company's products, including AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, CholesLo, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax to be drug claims.

Additionally, the product CholesLo was found to contain lovastatin, the active ingredient in Mevacor and similar generic drugs, typically taken for high cholesterol. CholesLo is marketed as a red yeast rice supplement, but red yeast rice contains only small amounts of lovastatin, suggesting the product contains enhanced or added lovastatin and cannot be sold as a dietary supplement.

See ConsumerLab.com's Reviews of Red Yeast Rice Supplements and Cholesterol-Lowering Supplements for tests of related products.

Examples of products with drug claims include Inflame & Pain Relief, which was promoted with statements such as "Lowers Heart Disease... Several studies suggest that Curcumin [an ingredient in the product] leads to improvements in endothelial function in the heart and can lower the risk of a heart attack by 65%."

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

The product Perfect Vitamin D & K was promoted with statements such as "Boosts Immune System: Dramatically reduces getting sick, the cold and flu."

See ConsumerLab.com's Reviews of Vitamin D Supplements and Vitamin K Supplements for tests of related products.

Blood Pressure Optimizer was promoted with statements such as "Aging increases blood pressure and your risk for heart attacks and strokes... Now you can reduce your blood pressure, risk factors and worry with one solution — naturally."

See ConsumerLab.com's Answer to the question Which supplements can help to lower blood pressure? for more information.

Lean Optimizer was promoted with statements such as "African Mango [an ingredient in the product] can help... prevent obesity by activating enzymes that control glucose and breakdown fat" and "Green Tea Extract [an ingredient in the product]... its [sic] also been linked to managing blood pressure."

See ConsumerLab.com's of African Mango Supplements Review Article and Green Tea Review for information about related products.

In addition, these products were found to be misbranded because they fail to bear adequate directions for their intended use.

For more information, use the link below.

Warning Letter: Dr. Sam Robbins, Inc. dba HFL Solutions, LLC

See related warnings:

FDA Warns Seller of Joint Health and Cholesterol Supplements

Seller of Apple Cider Vinegar, Joint Supplements & More Warned for Drug Claims

FDA Warns Seller of Milk Thistle, Chromium, Joint Supplements & More for Manufacturing Violations

Seller of Vitamin D, MSM, Selenium & More Warned for Drug Claims

Seller of Vitamin D, Omega-3's, Whey Protein & More Warned for Drug Claims