Source: https://www.casewatch.net/fdawarning/prod/2011/hcg_platinum.shtml
Timestamp: 2020-02-21 06:04:45
Document Index: 64053887

Matched Legal Cases: ['§331', '§ 353', '§ 41', '§ 321', '§321', '§331', '§355', '§ 321', '§353', '§353', '§ 353', '§331', '§321', '§ 503', '§ 503']

FDA Warning Letter to HCG Platinum LLC
Kevin Wright, CEO
14513 South Center Point Way
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.hcgplatinum.com. Based on our review, "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" are unapproved new drugs 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 are misbranded in violation of sections 503 and 301 of the Act [21 U.S.C. §§ 353 and 331].
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), aff'd, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat'l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), aff'd, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, slip op. 18-20, 2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009) http://www.ftc.gov/os/adjpro/d9329/091224commissionopinion.pdf, pet. for review den., 2010 WL 5108600 (D.C. Cir. Dec. 10, 2010).
"Lose up to 1 pound a day"
"Therefore, when you go on a very low calorie diet (VLCD), HCG helps the body make up the difference in the calories it needs to function by using your stored fat as food. The result is rapid weight loss."
"Fat burning"
"Muscle Growth"
"Appetite Control"
"Higher Energy
"X-30's key ingredient Irvingia Gabonensis has been clinically proven to promote weight loss, burn fat, reduce LDL cholesterol and improve blood sugar levels."
The claims made on your product labeling and website for "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" clearly demonstrate that these products are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man and intended to affect the structure or any function of the body.
Further, "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. §321(p)] because there is no evidence that they are generally recognized as safe and effective for their 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 are no FDA-approved applications on file for the above products. Therefore, the marketing of "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" without approved applications constitutes a violation of these provisions of the Act.
We recognize that labeling identifies these products as homeopathic drugs 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 "[d]rug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products."
"HCG Platinum" lists its active ingredients as "HCG (Human Chorionic Gonadotropin) 6x, 12x, 30x, 60x, L-Arginine 3x, 12x, 30x, Acetyl L-Carnitine 3x, 12x, 30x, L-Omithine 3x, 12x, 30x." Human Chorionic Gonadotropin (HCG), L-Arginine, Acetyl L-Carnitine, and L-Omithine are not established homeopathic active ingredients included in the HPUS or any of the addenda or supplements. Furthermore, to our knowledge, HCG, L-Arginine, Acetyl L-Carnitine, and L-Omithine are not listed in any recognized materia medica containing information on the preparation of homeopathic medicines. Therefore, HCG, L-Arginine, Acetyl L-Carnitine, and L-Omithine are not considered homeopathic drug ingredients and "HCG Platinum" is not considered a homeopathic drug product under the CPG.
"HCG Platinum X-30" and "HCG Platinum X-14" list their active ingredients as "Agnus Castus (Chaste Tree Berry) 3x, 12x, 30x, Angelica sinensis (Dong Quai) 3x, 12x, 30x, Acetyl L-Carnitine 3x, 12x, 30x, Cimicifuga racemosa (Black Cohosh) 3x, 12x, 30x, Dioscorea villosa (Wild Yam) 3x, 12x, 30x, L-Arginine 3x, 12x, 30x, L-Omithine 3x, 12x, 30x." Although Agnus Castus, Angelica sinensis, Cimicifuga racemosa, and Dioscorea villosa are established homeopathic ingredients listed in the HPUS, Acetyl L-Carnitine, L-Arginine, L-Omithine are not established homeopathic active ingredients included in the HPUS or any of the addenda or supplements. Furthermore, to our knowledge, Acetyl L-Carnitine, L-Arginine, L-Omithine are not listed in any recognized materia medica containing information on the preparation of homeopathic medicines. Therefore, Acetyl L-Carnitine, L-Arginine, L-Omithine are not considered homeopathic drug ingredients and "HCG Platinum X-30" and "HCG Platinum X-14" are not considered homeopathic drug products under the CPG.
Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14."
"HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" are prescription drugs 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 only upon a prescription by a practitioner licensed by law to administer such drug. Your labeling provides that your products should be taken in conjunction with a very low calorie diet (VLCD). A VLCD should only be used under proper medical supervision.
Further, "HCG Platinum X-30" is a prescription drug within the meaning of section 503(b)(1) of the Act because it is intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. For example, your product includes claims for diabetes ("improve blood sugar levels") and heart disease (e.g., "reduce LDL cholesterol levels"). Because they are subject to section 503(b)(1) of the Act, "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" are misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)] in that their labels fail to bear the symbol, "Rx only."[2] Your marketing of these misbranded products violate sections 301(a) and (k) of the Act [21 U.S.C. §§331(a) and (k)].
We note that under section 201(ff)(3)(B) of the Act [21 U.S.C. §321 (ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505, which was not marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Pregnyl, which contains HCG as the active ingredient, as a new drug on October 20, 1976. To FDA's knowledge there is no evidence that HCG was marketed as a dietary supplement or food prior to FDA approval of Pregnyl. As such, a product containing HCG could not be a dietary supplement.
Your reply should be directed to the attention of Ms. Nancy Schmidt, Compliance Officer, P.O. Box 25087, Denver, CO 80225-0087. If you have questions regarding any issue in this letter, please contact Ms. Schmidt at (303) 236-3046.
FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or an Administrative Cease and Desist Order. An order also may require that you pay back money to consumers. Please notify FTC via electronic mail at healthproducts@ftc.gov, within fifteen working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Richard Cleland at (202) 326-3088.
[1] For example, "HCG Platinum" includes the ingredients "HCG (Human Chorionic Gonadotropin 6x, 12x, 30x, 60x), L-ARginine 3x, 12x, 30x, Acytel L-Carnitine 3x, 12x, L-Omithine 3x, 12x, 30x."
[2] The Agency's guidance, "Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)," states that, in accordance with § 503(b)(1) of the Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, "Caution: Federal law prohibits dispensing without prescription." This guidance was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended § 503(b)(4) of the Act to require that the label of a prescription drug must bear the symbol "Rx only."