On May 2, 2013, the FDA issued a warning letter to Alternative Health Supplements, following a review of the company’s website, which found statements made about several dietary supplements, including Regenerect, Alligin, Astaxanthin Advantage, HDL Cholesterol Management, Resveratrol, Coral Calcium Supreme, Blood Sugar Imbalance, and Shark Liver Oil, to be drug claims.
Regenerect was promoted as a sexual enhancement supplement for men, with statements such as, ”… an erectile stimulant that increases the size and duration of erections,” and “an alternative solution to prescription products like Viagra.”
The FDA also determined that the Regenerect sold on Alternative Health’s website contained undeclared tadalafil, the active ingredient in the FDA approved prescription drug for erectile dysfunction, Cialis. Tadalafil can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure.
Regenerect was also found to be misbranded because the label fails to warn consumers that it contains tadalafil. The supplement was recalled in 2012 for containing this drug.
(See ConsumerLab.com’s Review of Sexual Enhancement Supplements for tests of related products.)
Alligin contains ginger and allicin, a compound found in garlic. It was promoted as an immune-system booster with statements such as “Perhaps Allicin's most important power in our modern age of antibiotic-resistant germs and ever-new microbial diseases (SARS, flesh-eating Strepto-coccus, West Nile encephalitis virus, AIDS ... ) is its amazing broad-spectrum antimicrobial activity.”
(See ConsumerLab.com’s Review of Garlic Supplements for tests of related products.)
Astaxanthin Advantage contains astaxanthin and was promoted to fight cancer, cardiovascular disease and aging with statements such as “Astaxanthin may help the body avoid the onset of cancerous cells, assist with neurodegenerative diseases...” and “Astaxanthin may support the prevention of the initiation of cancer cells in the tongue, oral cavity, large bowel, bladder, uterus, and breast.”
(See ConsumerLab.com’s Encyclopedia of Natural Products article on Astaxanthin for more information about this ingredient, and see Reviews of Vitamin A Supplements, Vision Supplements and Fish Oil Supplements for tests of related products.)
HDL Cholesterol Management contains Sitrinol, a patented ingredient comprised of citrus fruit extract, palm fruit extract, and alpha tocotrienols. It was promoted to lower cholesterol, with statements such as “In response to a growing demand for safe alternatives to prescription drugs Sytrinol was developed over a period of 12 years of painstaking research. Supported by 3 human clinical studies as well as animal studies showing a reduction of 22% in LDL.”
(See ConsumerLab.com’s Review of Cholesterol-Lowering Supplements for tests of related products.)
Resveratrol was promoted for dementia, diabetes and heart disease, with statements such as “Resveratrol may inhibit platelets from clumping together, thus reducing the risk of deadly blood clots that can lead to heart attack and stroke.”
(See ConsumerLab.com’s Review of Resveratrol Supplements for tests of related products.)
Coral Calcium Supreme was promoted with statements such as “restores your alkalinity . . . Most degenerative diseases attributed to aging such as cancer, osteoporosis, heart disease, and other diseases, such as allergy, kidney stones and gallstones, have all been scientifically linked to mineral deficiencies.”
(See ConsumerLab.com’s Review of Calcium Supplements for tests of related products.)
Blood Sugar Imbalance was promoted for hypoglycemia with testimonial statements such as “Bell Blood Sugar Imbalance Helped with my hypoglycemia!”
Shark Liver Oil was promoted for the prevention of infection and illness, including asthma, arthritis, diabetes and flu.
(See ConsumerLab.com’s Review of Fish Oil and Omega-3 Supplements for tests of related products.)
To read the FDA’s warning letter, use the red link below.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm352042.htm
