Posted October 21, 2014

Seller of Weight Loss, Saw Palmetto Supplements and More Warned for Drug Claims

On October 9, 2014, the FDA issued a warning letter to Bethel Nutritional Consulting, Inc., following a review of the company's website which found statements made about 15 Day Detox Diet, Alpha Lipoic Acid. 300 mg. Capsules, Black Cohosh, B Thinner, Carbo-Fat, Cascara sagrada, Cholest Away, Dong Quai, Eagle Eye, Garlic and Parsley, Ginseng Extract, Lecithin, Omega Max EPA, Potassium, Saw Palmetto, St. John's Wort, Sweet Sleep, Ultimate B Burner, Valerian Root, Women Plus, and Yohimbe to be drug claims.

15 Day Detox Diet, B Thinner, Carbo-Fat and Ultimate B Burner were promoted for weight loss, lowering cholesterol and/or improving glucose metabolism with statements such as "The 15 Day Detox Diet ...may reduce inflamation and preventing [sic] atherosclerosis," "B Thinner ...Assist in helping combat ...obesity," and "Ultimate B Burner...Normalize the levels of blood sugar."

(In 2013, Bethel Nutritional recalled several other weight loss products because they were found to contain undeclared drugs.)

(See ConsumerLab.com's Reviews of Weight Loss Supplements and Cholesterol-Lowering Supplements for tests of related products.)

Alpha Lipoic Acid capsules were promoted to treat Alzheimer's disease, with statements such as "[A]ssist with preventing Alzheimer's disease as well as stroke, and removing mercury from brain tissue."

(See ConsumerLab.com's Review of Alpha Lipoic Acid Supplements for tests of related products.)

Black Cohosh was promoted to treat a number of conditions, with statements such as "Black Cohosh ...is now a popular alternative to hormone replacement therapy (HRT). Native Americans were the first to use the Black Cohosh root as a helping herb for malaria, rheumatism... colds... hives... Modern research has shown that Black Cohosh treats... depression and... Black Cohosh... serves as a mild anti-inflammatory. Research has also shown that Black Cohosh is a mild sedative and decongestant."

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

Cascara sagrada was promoted to treat intestinal conditions, with statements such as "Recommended for... treatment of intestinal parasites and colitis."

Cholest Away was promoted to lower cholesterol with statements such as "Lowers cholesterol levels as effectively as statins without the side effects. Red Yeast Rice Increases HDL levels and also lowers elevated serum triglyceride levels. Use in conjunction with CO-Q10 for difficult cholesterol."

(See ConsumerLab.com's Review of Red Yeast Rice Supplements for tests of related products.)

Ginseng Extract was promoted to treat a variety of conditions, with statements such as "May help prevent atherosclerosis, adrenal insufficiency ...anemia, cancer, chronic illness, depression and diabetes."

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

Omega Max EPA was promoted to treat cardiovascular disease and arthritis, with statements such as "Helps lower the risk of heart attack, stroke and cardiac arrhythmias" and "Helps reduce high blood pressure and inflammatory diseases such as rheumatoid arthritis."

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

Potassium was promoted to treat cardiovascular disease with statements such as "Regulating blood pressure, protecting against hypertension, strokes, cardiovascular disease."

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

Saw Palmetto was promoted to treat several conditions, with statements such as "[R]educing colds ...asthma, chronic bronchitis, migraines and cancer."

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

St. John's Wort was promoted to treat depression, anxiety, and other conditions, with statements such as "St. John's Wort has been used for centuries by its great benefits in the treatment of the nervous system, especially in depressive disorders and anxiety ...St. John's Wort has been used in the helping ...hemorrhoids and insomnia."

(See ConsumerLab.com's Review of St. John's Wort Supplements for tests of related products.)

Valerian Root was promoted to treat a number of conditions, with statements such as "May help reduce the high blood pressure, the pain, the spasms and muscle cramps disorders of attention deficit hyperactivity (ADHD/ADHD)."

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

Yohimbe was promoted to treat sexual dysfunction, with statements such as "May assist in sexual dysfunction, including erectile dysfunction."

(See ConsumerLab.com's Review of Sexual Enhancers for tests of related products.)

See Related Warnings:

Weight Loss Supplement Recalled Due To Undeclared Drugs

Weight Loss Supplement Recall Expanded

Seller of Multivitamin Warned for Drug Claims

Seller of Joint Pain Supplement Warned for Drug Claims

Seller of "Nerve", "Cleanse" and Probiotic Supplements Warned for Drug Claims

Seller of Immune Supplement Warned for Drug Claims

Seller of Joint Supplement 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.