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Posted May 3, 2013

Maker of Omega-3, Saw Palmetto, St. John’s Wort Supplements And More Warned For Manufacturing Violations and Drug Claims

On March 19, 2013, the FDA issued a warning letter to Sunset Natural Products Inc. following a facility inspection which found the company's products, including Hongofin Anti-Fungus Spray w/Aloe Vera, Hongafin (pinceladas), Hongafin Anti-Fungus Powder, Fungus Control Formula by IDLS, Body Anti-Fungal Cream, Shampoo, Melatonin, Selenium, Omega 3, Spirulina, Alfalfa, Aloe Vera, Cat's Claw, Circulation, Garlic, Healthy Male Prostate, Echinacea, Saw Pallmetto, St. John's Wort Extract, DHEA, and Sugar Burner, to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements.

These violations include failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient and failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement.

In addition, statements made about these supplements on the company's website, www.sunsetnaturallab.com, were found to be drug claims.

For example, Hongofin Anti-Fungus Spray with Aloe Vera was promoted with statements such as "Kills Athlete's Foot fungus … Relieves Itching … Burning." Statements made about the company's Melatonin included "Melatonin appears to keep some forms for cancer from spreading as rapidly as tumors that have not been treated."

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

Sunset Natural's Selenium was promoted with statements such as "Selenium may protect against some forms of cancer ... Selenium … is believed to reduce … viral hepatitis."

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

The company promoted its Omega-3 supplement with statements such as "Large doses of fish oil may be effective for conditions and maladies including Parkinson's disease … bipolar disease, attention-deficit hyperactivity disorder, alcoholism … Alzheimer's disease, diabetes, and arthritis," and its St. John's Wort supplement with statements such as "Best known for use as a mild antidepressant. Benefits in people with depression who take psychotropic drugs…Relieves mild to moderate depression…Fights retroviruses."

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

Echinacea was promoted with statements such as "Echinacea, is used to treat flu, fevers, coughs and colds, bronchitis, urinary tract infections, wounds and burns, and inflammation of the mouth and pharynx. It is also used to prevent infection …" and Saw Palmetto was promoted with statements such as "Saw palmetto has been used to treat the symptoms of benign prostatic hypertrophy (BPH) ...also used for other conditions, including chronic pelvic pain, bladder disorders."

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

Melatonin, Selenium, Omega-3, Spirulina, Alfalfa, Cat's Claw, Garlic, Healthy Male Prostate, Echinacea, Saw Pallmetto, St. John's Wort Extract, DHEA, and Sugar Burner products were also found to be misbranded because the labels contained inadequate directions for use.

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