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The product appears to be an unapproved new drug as the product labeling and website include claims such as: Medical claims made in product websites. This product is used as a drawing salve for the inflammation of subcutaneous tissues. Organic Coffee Notes: The product appears to be an unapproved new drug as the product's promotional website provides a recipe for using coffee as a rectal enema and includes claims such as: It causes the liver to produce more bile which contains processed toxins and moves bile out toward the small intestine for elimination Coffee with Enema Kit Notes: Johns Wort.

CDER has determined that this product is being promoted as an alternative to prescription drugs such as Fen-Phen and Imipramine and is intended to treat obesity and depression and claims to correct the biochemical cause of weight loss. The product is described as an MAO Inhibitor. MAO inhibitors are a class of anti-depressants which can pose health risks to patients if cetain dietary restrictions are not observed during therapy.

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Also; product website is making multiple curative claims. Puralor Ci Tablets Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: Osteo Joint Ease Notes: Product labels made medical claims. Glucosamine and Chondroitin Sulfate Notes: In addition, websites associated with the product include claims such as: African Superman Tablets Notes: FDA analysis of product found product contains undeclared Sildenafil. The product contains six types of essential oils. Detox Pads transdermal - V. Detox Pads transdermal -; V.


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    Peppermint Scrub Notes: The product appears to be an unapproved new drug as the product labeling and firm's website contain claims that indicate drug uses for the product including; "[W]ith regular use will target cellulite"; "Caffeine will stimulate blood flow"; and "removing Product does not contain Salicylic Acid and is misbranded. Glutathione Notes: Product was manifested as Glutathione; however it was found to contain undeclared Human Growth Hormone. Healing Collection 4 Tea. Also diabetic choice tea.

    Labeling of this herbal product makes drug claims related to the mitigation of cholesterol; diabetes; and high blood pressure thus causing the product to be a new drug; for which no approval is in effect. The product may be entering as a dietary supplement; therefore we have included various product codes. Magic Power Coffee Notes: The product is labeled as a dietary supplement. LMZ Int'l Ltd. Licorice Coughing Liquid Notes: The only product currently subject to the guidance outlined in this import alert is Licorice Coughing Liquid;Problem s ; Unapproved new drug.

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