Source: https://www.ftc.gov/sites/default/files/documents/public_statements/joint-fda/ftc-warning-letter-concerning-product-labeling-human-chrorionic-gonadotropin-hcg-drugs/ucm282052.htm
Timestamp: 2018-06-20 07:46:14
Document Index: 518616606

Matched Legal Cases: ['§ 331', '§ 353', '§ 321', '§ 321', '§ 331', '§ 355', '§ 321', '§ 353', '§ 353', '§ 353', '§ 331']

HCG Diet Direct, LLC 11/28/11
This letter is to advise you that the United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) have reviewed your firm’s product labeling and your website at www.hcgdietdirect.com. Based on our review, “HCG Diet Homeopathic Drops” is an unapproved new drug in violation of sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331 and 355] and is misbranded in violation of sections 503 and 301 of the Act [21 U.S.C. §§ 353 and 331].
We recognize that a number of pages on your website contain a disclaimer stating that the products are not intended to diagnose, treat, cure, or prevent any disease. However, notwithstanding this disclaimer, the claims made on your product labeling and website for “HCG Diet Homeopathic Drops” clearly demonstrate that this product is a drug as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because it is intended to affect the structure or any function of the body.
Further, “HCG Diet Homeopathic Drops” is a “new drug” within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because there is no evidence that it is generally recognized as safe and effective for its intended uses.
Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the product. There is no FDA-approved application on file for the above product. Therefore, the marketing of “HCG Diet Homeopathic Drops” without an approved application constitutes a violation of these provisions of the Act.
We recognize that labeling identifies this product as a homeopathic drug with active ingredients measured in homeopathic strengths.[1] The definition of “drug” in section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. The CPG defines a homeopathic drug as: “Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.” The CPG additionally states that “drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.”
“HCG Diet Homeopathic Drops” lists its active ingredients as “HCG 12,30,60x, Arginine 3x,12x,30x, L-Carnitine 3x,12x,30x and Ornithine 3x,12x,30x, Foeniculim vulgare 2x, Antimonium crudum 8x, Gallium [sic] aparine 6x, Rubus idaeus 6x, Calcarea carbonica 6x, Lac defloratum 6x, Manganum metallicum 6x and Phosphorus 6x.” Although, Foeniculim vulgare, Antimonium crudum, Gallium [sic] aparine, Calcarea carbonica, Lac defloratum, Manganum metallicum, and Phosphorus are established homeopathic ingredients listed in the HPUS, HCG, Arginine, and L-Carnitine are not established homeopathic active ingredients included in the HPUS or any of the addenda or supplements. Furthermore, to our knowledge, HCG, Arginine, and L-Carnitine are not listed in any recognized materia medica containing information on the preparation of homeopathic medicines. Therefore, HCG, Arginine, and L-Carnitine are not considered homeopathic drug ingredients and “HCG Diet Homeopathic Drops” is not considered a homeopathic drug product under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to “HCG Diet Homeopathic Drops.”
“HCG Diet Homeopathic Drops” is a prescription drug under section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)]. Section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)] provides that a drug which “because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug” shall be dispensed upon a prescription by a practitioner licensed by law to administer such drug. Your labeling provides that your product should be taken in conjunction with a very low calorie diet (VLCD). A VLCD should only be used under proper medical supervision. Because it is subject to section 503(b)(1) of the Act, “HCG Diet Homeopathic Drops” is misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)] in that its label fails to bear the symbol, "Rx only."[2] Your marketing of this misbranded product violates sections 301(a) and (k) of the Act [21 U.S.C. §§ 331(a) and (k)].
Page Last Updated: 12/05/2011