Posted April 26, 2013

Seller of Immune, Cholesterol, Liver and Blood Sugar Products Warned For Drug Claims

On March 20, 2013, the FDA issued a warning letter to Birkdale Medicinals LLC, following a review of the company's website which found statements made about Birkdale products, including Immune Response 247, Cholestat, Silymarin 81 and LevelStat, to be drug claims.

Immune Response 247 contains Agaricus blazei extract, Coriolis versicolor PSP extract, reishi extract, shitake extract, maitake mushroom and Cordyceps sinensis. It was promoted for immune system support, with statements such as "Studies have shown that medicinal contain … properties that … offer help … individuals with cancer, asthma, and other chronic illnesses."

(See the Reishi Mushroom Supplements Review for tests of related products.)

Cholestat contains vitamin B6, vitamin B12, vitamin C, vitamin E, folate, chromium, inositol, policosanol, plant enzymes, guggul extract, phytosterols, N-acetyl cysteine, L-arginine, soy lecithin, gynostemma extract, hesperidin, rose hips extract, Reishi mycellia , Maitake mycellia, Cordyceps mycellia, green tea extract and L-taurine. It was promoted for the reduction of cholesterol and arterial plaque, with statements such as "Cholestat also … help[s] control oxidation of LDL and therefore reduce plaque formation on the arteries."

(See's Reviews of Cholesterol-Lowering Supplements for tests of related products, and see Reviews of Vitamin B Supplements, Vitamin C Supplements, L-Arginine Supplements and Green Tea Supplements for tests of products containing these ingredients.)

Silymarin 81 contains milk thistle extract, and was promoted as a remedy for liver problems, with statements such as "The Silymarin in milk thistle has shown positive effects in treating many forms of liver ailments, including hepatitis, necroses, and cirrhosis."

(See's Review of Milk Thistle Supplements for tests of related products.)

LevelStat contains chromium, banaba leaf extract, lipoic acid, L-Taurine, bitter melon fruit extract, cinnamon extract, Pterocarpus marsupium extract, Gymnema sylvestre extract, quercetin, green tea extract, rose hips extract, bilberry extract, blueberry leaf extract and turmeric extract. It was promoted for blood sugar control, with statements such as "Studies have shown the antioxidant activity of ALA [alpha lipoic acid]… reduces cardiovascular complications of diabetes…slows down the effects of diabetic neuropathy cardiovascular complications of diabetes."

(See's Reviews of Chromium Supplements, Tumeric Supplements and Alpha Lipoic Supplements for tests of related products.)

Immune Response 247, Cholestat, Silymarin 81, and LevelStat were also found to be misbranded because the labels did not provide adequate directions for use.

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