HCG diet no more?

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HCG Diet Direct, LLC 11/28/11

UNITED STATES OF AMERICA

FEDERAL TRADE COMMISSION

BUREAU OF CONSUMER PROTECTION

WASHINGTON, D.C. 20580

DEPARTMENT OF HEALTH

AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

SILVER SPRING, MD 20993

WARNING LETTER

November 28, 2011

Clint Ethington, CEO

HCG Diet Direct, LLC

7850 N Silverbell Road, #114-287

Tuscon, AZ 85743-5223

Dear Mr. Ethington:

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].

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

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

<http://www.mynewsletterbuilder.com/tools/refer.php?s=4938328381 & u=25239001 & v=3 & \

key=b8ef & skey=353da4e29f & url=http%3A%2F%2Fwww.ftc.gov%2Fos%2Fadjpro%2Fd9329%2F09\

1224commissionopinion.pdf> , pet. for review den., 2010 WL 5108600 (D.C. Cir.

Dec. 10, 2010).

Statements on the immediate container label that document the intended uses of

your product include, but are not limited to, the following:

· " Ultimate Weight Loss & Metabolism Formula "

· " Provides homeopathic support for managing weight along with proper

dieting. "

In addition to the above, your website documents the intended uses of your

products including, but not limited to, the following:

· " Lose 26 lbs in 26 days if you follow the HCG Diet Direct

weight loss plan as directed. "

· " Our homeopathic HCG Diet Direct weight loss plan in conjunction

with the low calorie developed diet, is formulated to encourage extra fat to be

mobilized for energy and eliminate the rest. "

· " HCG Diet Direct formula stimulates the body's natural ability to

make adjustments to alleviate imbalances. "

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( or

(j) of the Act [21 U.S.C. § 355( 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]

<http://www.mynewsletterbuilder.com/tools/refer.php?s=4938328381 & u=25239003 & v=3 & \

key=12e1 & skey=353da4e29f & url=http%3A%2F%2Fwww.fda.gov%2FICECI%2FEnforcementActio\

ns%2FWarningLetters%2Fucm282052.htm%23_ftn1> 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((1) of

the Act [21 U.S.C. § 353((1)]. Section 503((1) of the Act [21 U.S.C. §

353((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((1) of the Act, " HCG Diet

Homeopathic Drops " is misbranded under section 503((4) of the Act [21 U.S.C. §

353((4)] in that its label fails to bear the symbol, " Rx only. " [2]

<http://www.mynewsletterbuilder.com/tools/refer.php?s=4938328381 & u=25239005 & v=3 & \

key=acf9 & skey=353da4e29f & url=http%3A%2F%2Fwww.fda.gov%2FICECI%2FEnforcementActio\

ns%2FWarningLetters%2Fucm282052.htm%23_ftn2> Your marketing of this misbranded

product violates sections 301(a) and (k) of the Act [21 U.S.C. §§ 331(a) and

(k)].

The issues and violations cited in this letter are not intended to be an

all-inclusive statement of violations that exist in connection with your

products. You are responsible for investigating and determining the causes of

the violations identified above and for preventing their recurrence or the

occurrence of other violations. It is your responsibility to assure that your

firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter.

Failure to promptly correct these violations may result in legal action without

further notice, including, without limitation, seizure and injunction. Other

federal agencies may take this Warning Letter into account when considering the

award of contracts.

We note that under section 201(ff)(3)( of the Act [21 U.S.C. § 321

(ff)(3)(], 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.

In addition, we have the following comment: Your firm's website,

www.hcgdietdirect.com, makes use of the FDA logo. The FDA logo is for the

official use of FDA and not for the use of the private sector. To the public,

such use would send a message that FDA favors or endorses an organization, its

activities, its products, its services, and/or its personnel which it does not

and cannot do. Misuse of the FDA logo may violate federal law and subject those

responsible to civil and/or criminal liability.

Within fifteen working days of receipt of this letter, please notify this office

in writing of the specific steps that you have taken to correct violations.

Include an explanation of each step being taken to prevent the recurrence of

violations, as well as copies of related documentation. If you cannot complete

corrective action within fifteen working days, state the reason for the delay

and the time within which you will complete the corrections. Furthermore, please

advise this office of what actions you will take to address product that you

have already distributed.

Your reply should be directed to the attention of J. Stamp, Compliance

Officer, 19701 Fairchild,Irvine, CA 92612-2506. If you have questions

regarding any issue in this letter, please contact Mr. Stamp at .

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@..., 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

Cleland at .

Sincerely,

/S/

Alonza E. Cruse, District Director

Los Angeles District Office

Food and Drug Administration

/S/

K. Engle, Associate Director

Division of Advertising Practices

Federal Trade Commission

/S/

Ilisa B.G. Bernstein, Pharm.D., J.D.

Acting Director, Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

cc:

J. St. Clair, Esq.

215 North Court Avenue, 2nd Floor

Tucson, AZ 85701

Mr. Clint Ethington

5880 N. Tucson Mountain Dr.

Tucson, AZ 85743

Mr. Clint Ethington

2753 East Broadway

Suite 101-205

Mesa, AZ 85204

________________________________

[1]

<http://www.mynewsletterbuilder.com/tools/refer.php?s=4938328381 & u=25239007 & v=3 & \

key=5299 & skey=353da4e29f & url=http%3A%2F%2Fwww.fda.gov%2FICECI%2FEnforcementActio\

ns%2FWarningLetters%2Fucm282052.htm%23_ftnref1> For example, the label for " HCG

Diet Homeopathic Drops " includes the ingredients " 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 aparine 6x, Rubus idaeus 6x, Calcarea

carbonica 6x, Lac defloratum 6x, Manganum metallicum 6x and Phosphorus 6x, base

of 20% USP alcohol. "

[2]

<http://www.mynewsletterbuilder.com/tools/refer.php?s=4938328381 & u=25239009 & v=3 & \

key=c3d9 & skey=353da4e29f & url=http%3A%2F%2Fwww.fda.gov%2FICECI%2FEnforcementActio\

ns%2FWarningLetters%2Fucm282052.htm%23_ftnref2> The Agency's guidance,

" Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15), " states

that, in accordance with § 503((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((4) of the Act to require that

the label of a prescription drug must bear the symbol " Rx only. "

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com

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