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    Therapeutic claims for additional products are included in your firms product labeling. Products and claims include removes atherosclerotic plaque, high blood pressure, heart disease and stroke cure those in the aftermath of a very serious disease or illness, all forms of debilitation, neurasthenia, anemia, muscle atrophy and digestive disorders montezumas revenge (diarrhea), mild food poisoning, and stomach flu accompanied by sudden, violent cramping, vomiting and headaches abnormal menstruation, suppressed menstrual flow, painful or difficult menstruation, uterine bleeding improving t-cell counts, upper respiratory tract infections, fever, coughing, sore throat, colds, flu, alternative to antibiotics relieve pain, heal wounds, stop bleeding, gastric and genitourinary disorders, inflamed mucous membranes including stomach, intestinal, vaginal and rectal anti-bacterial action helps reduce or prevent infection of open sores antibiotic, anti-inflammatory, reduce fevers, fight infections, high blood pressure, mental disorders hayfever, allergies, drying phlegm, opens nasal passages, stuffj noses, sneezing, supplement to cold formulas infectious diseases, wounds, toothache, sexually transmitted diseases, as potent as ketoconazole, a common anti-fungal drug insomnia, hysteria, natural tranquilizer unlike many prescription drugs, it has almost no unpleasant side-effects this letter is not intended to be an all-inclusive review of all labeling and products your firm markets and distributes. Labeling for these products contain therapeutic claims that cause the products to be drugs under section 201(g) of the federal food, drug and cosmetic act (the act).

    Alzheimers, helping the body to fight disease chronic or acute joint pain, low back pain, achy knees and ankles, swollen or puffy joints, flaring of the sciatic nerve, rheumatoid arthritis prostate enlargementiswelling, reduces pain, makes urination easier lingfil reishi capsules lowering blood pressure, treat high cholesterol, normalizing blood pressure, cure allergies, effective tumor fighter treat urinary, prostate and reproductive disorders, enlarged prostate, enuresis, nocturia, atrophy of the testes, impotence, inflammation of prostrate antidepressant, anti-viral activity against herpes simplex, influenza, and epstein-barr virus urinary tract infection, headaches, migraine headaches, gallstones, inflamed gallbladder, jaundice and hepatitis, herpes, external genital and vaginal discharge, kidney infection, testicle swelling high blood pressure, migraine headaches, a ringing in the ears, hypertension. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within the corrections will be completed. Also, the labeling for your products state that these medicines are created from natural drugs.

    Your response should include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. It is your responsibility to ensure that all products your firm markets and distributes are in compliance with the act and its related regulations. Website design, development, and hosting with superb technical support.

    Your reply should be directed to the food and drug administration, attention kirk d. You should take prompt action to correct all labeling and promotional violations. The labeling also states that all herbal ingredients imported into the us are tested by the fda, and all our firms products are laboratory tested to meet or surpass fda standards.

    This letter is in reference to the marketing and distribution of various healing herbs of china products by your firm, kgb media, 1903 merrywood dr, edison, nj 08817. The fda does not perform laboratory testing on all herbal ingredients imported into the united states, further, we are unaware of the existence of any fda testing standards for products such as yours or of any fda programs to perform this testing. Please include copies of any available documentation demonstrating that corrections have been made.

    Such regulatory action can include seizure of products, injunction of marketing and distributing operations, or criminal prosecution. The above products are new drugs as defined by section 201(p) of the act. Section 502(f) of the act, and (b) their labeling is fhlse and misleading because the labeling suggests the products are safe and effective for their intended use, when in fact, this has not been established, as is called for in section 502(a) of the act. . Labeling includes product labels, catalogs, internet sites and any other promotional literature that you distribute in connection with your products.


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    If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within the corrections will be completed. Such regulatory action can include seizure of products, injunction of marketing and distributing operations, or criminal prosecution. Labeling includes product labels, catalogs, internet sites and any other promotional literature that you distribute in connection with your products. Please include copies of any available documentation demonstrating that corrections have been made. If you do not promptly correct the violations, fda may execute regulatory action against you andor your firm without further notice.

    The fda does not perform laboratory testing on all herbal ingredients imported into the united states, further, we are unaware of the existence of any fda testing standards for products such as yours or of any fda programs to perform this testing. The above products are new drugs as defined by section 201(p) of the act. Alzheimers, helping the body to fight disease chronic or acute joint pain, low back pain, achy knees and ankles, swollen or puffy joints, flaring of the sciatic nerve, rheumatoid arthritis prostate enlargementiswelling, reduces pain, makes urination easier lingfil reishi capsules lowering blood pressure, treat high cholesterol, normalizing blood pressure, cure allergies, effective tumor fighter treat urinary, prostate and reproductive disorders, enlarged prostate, enuresis, nocturia, atrophy of the testes, impotence, inflammation of prostrate antidepressant, anti-viral activity against herpes simplex, influenza, and epstein-barr virus urinary tract infection, headaches, migraine headaches, gallstones, inflamed gallbladder, jaundice and hepatitis, herpes, external genital and vaginal discharge, kidney infection, testicle swelling high blood pressure, migraine headaches, a ringing in the ears, hypertension. Section 502(f) of the act, and (b) their labeling is fhlse and misleading because the labeling suggests the products are safe and effective for their intended use, when in fact, this has not been established, as is called for in section 502(a) of the act. The labeling also states that all herbal ingredients imported into the us are tested by the fda, and all our firms products are laboratory tested to meet or surpass fda standards.

    Your reply should be directed to the food and drug administration, attention kirk d. Products and claims include removes atherosclerotic plaque, high blood pressure, heart disease and stroke cure those in the aftermath of a very serious disease or illness, all forms of debilitation, neurasthenia, anemia, muscle atrophy and digestive disorders montezumas revenge (diarrhea), mild food poisoning, and stomach flu accompanied by sudden, violent cramping, vomiting and headaches abnormal menstruation, suppressed menstrual flow, painful or difficult menstruation, uterine bleeding improving t-cell counts, upper respiratory tract infections, fever, coughing, sore throat, colds, flu, alternative to antibiotics relieve pain, heal wounds, stop bleeding, gastric and genitourinary disorders, inflamed mucous membranes including stomach, intestinal, vaginal and rectal anti-bacterial action helps reduce or prevent infection of open sores antibiotic, anti-inflammatory, reduce fevers, fight infections, high blood pressure, mental disorders hayfever, allergies, drying phlegm, opens nasal passages, stuffj noses, sneezing, supplement to cold formulas infectious diseases, wounds, toothache, sexually transmitted diseases, as potent as ketoconazole, a common anti-fungal drug insomnia, hysteria, natural tranquilizer unlike many prescription drugs, it has almost no unpleasant side-effects this letter is not intended to be an all-inclusive review of all labeling and products your firm markets and distributes. . Also, the labeling for your products state that these medicines are created from natural drugs. Website design, development, and hosting with superb technical support. Your response should include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. Therapeutic claims for additional products are included in your firms product labeling. It is your responsibility to ensure that all products your firm markets and distributes are in compliance with the act and its related regulations. Labeling for these products contain therapeutic claims that cause the products to be drugs under section 201(g) of the federal food, drug and cosmetic act (the act). This letter is in reference to the marketing and distribution of various healing herbs of china products by your firm, kgb media, 1903 merrywood dr, edison, nj 08817.

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