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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shaping Beauty, Inc. / H & S GMP Factory 7/14/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT

900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390

 

WARNING LETTER
11-PHI-16
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
 
                                                            July 14, 2011
 
Alina Kreymer, Owner
Shaping Beauty, Inc.
34 Beechwood Drive
Huntingdon Valley, PA 19005
 
Dear Ms. Kreymer:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection at your firm located at 34 Beechwood Drive, Huntingdon Valley, PA from January 12, 2011 through January 28, 2011. We have also reviewed your website at www.shapingbeauty.com
 
FDA has determined that Celerite Slimming Capsules; Celerite Slimming Tea; moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream; Hairgane Hair Regrowth Treatment;Arava Tea DIABEtea; mlis FIBER Wheat Bran and Psyllium capsules; mlis VITAL Antioxidant with Astaxanthin capsules; mlis RELIEF Muscle & Joint Aid capsules; and mlis EVENING PRIMROSE OIL softgels are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(a)] and misbranded drugs in violation of section 502 and/or 503 of the Act [21 U.S.C. §§ 352 and/or 353] as detailed below.
 
Products Marketed as Dietary Supplements with Undeclared Pharmaceutical Ingredient
 
FDA confirmed through laboratory analyses that Celerite Slimming Capsules and Celerite Slimming Tea contain undeclared sibutramine. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. 
 
You market Celerite Slimming Capsules and Celerite Slimming Tea as dietary supplements. However, under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization as a new drug. 
 
The investigational new drug (IND) application for Meridia (sibutramine) was received by FDA on December 24, 1985, and sibutramine became authorized for investigation as a new drug under an IND on January 23, 1986. When Meridia was approved for marketing as a new drug in the United States, the existence of substantial completed clinical investigations of sibutramine became public. Given that sibutramine was not marketed as a dietary supplement or as a food before Meridia was authorized for investigation as a new drug, Celerite Slimming Capsules and Celerite Slimming Tea, which contain sibutramine, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the Act.
 
Celerite Slimming Capsules and Celerite Slimming Tea are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body and, thus, are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. Labeling statements documenting these intended uses include, but are not limited to, the following:
  •  “CELERITE is a natural dietary supplement . . . that helps suppress appetite, increase energy and lose weight safely and effectively.”
  •  “CELERITE Slimming Capsules has been clinically proven to help quickly and effectively lose weight.”
  •  “What Celerite Slimming Tea does:
1.      Increases metabolism, promotes energy, speeds up weight loss
2.      Helps digestion (relieves constipation by loosening the bowels)
3.      Reduces blood pressure, blood sugar, prevents radiation.”
  •  “[N]ot only aids in weight loss but is known to cure menacing headaches.”
In addition, Celerite Slimming Capsules and Celerite Slimming Tea are new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. 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 FDA-approved application is in effect for it. The distribution or sale of Celerite Slimming Capsules and Celerite Slimming Tea without approved applications violates these provisions of the Act.
 
Celerite Slimming Capsules and Celerite Slimming Tea are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 C.F.R. § 201.5]. It is impossible to write “adequate directions for use” for Celerite Slimming Capsules and Celerite Slimming Tea for at least two reasons:  1) prior to withdrawal of Meridia’s approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs and 2) FDA approval of Meridia was withdrawn because of serious safety risks.  As such, the labeling of Celerite Slimming Capsules and Celerite Slimming Tea fail to bear adequate directions for their intended uses. Celerite Slimming Capsules and Celerite Slimming Tea are not exempt from the requirement that their labeling bear adequate directions for use under 21 C.F.R. §§ 201.100(c)(2) and 201.115 because no FDA-approved applications are in effect for these products. 
 
Additionally, under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C. § 321(n)], provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations . . .” Your products, Celerite Slimming Capsules and Celerite Slimming Tea, are misbranded under section 502(a) of the Act because their labeling makes false and misleading statements regarding safety and fails to reveal material facts with respect to consequences that may result from the use of these products. As described above, sibutramine may pose serious health risks to consumers which are only compounded by the fact that sibutramine is not declared on the label. 
 
Likewise, Celerite Slimming Capsules and Celerite Slimming Tea are misbranded under section 502(j) of the Act, [21 U.S.C. § 352(j)] because they are dangerous to health when used in the dosage or manner recommended in their labeling. As previously noted, sibutramine poses an increased risk of heart attack and stroke. The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Unapproved and Misbranded Over-the-Counter (OTC) Drugs
 
The labeling for “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” identifies polygonum extract 75% as an active ingredient. The labeling for this product contains the following statements of intended uses:
  •  “[N]atural solution for Acne. Intended for use by teenagers who suffer from pimples, acne, oily, red, and sensitive facial skin.”
  •  “[H]elps to rebuild the damaged skin tissues around the wound.”
  •  “Rapid regeneration, suitable for recent scarring.”
  •  “Treats pimples and Teenage Acne”
Based on the labeling described above, “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” is a drug as defined by section 201(g)(1) because it is intended to treat a disease and to affect the structure or function of the body of man. Based on the product’s labeled indications for use, “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” is subject to the requirements of the OTC Final Monograph for Topical Antimicrobial Drug Products (21 C.F.R. 333) Subpart D Topical Acne Drug Products. However, “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” is not formulated and labeled in conformance with this final monograph. 
 
Polygonum extract is not permitted as an active ingredient under the OTC Final Monograph for Topical Antimicrobial Drug Products Subpart D Topical Acne Drug Products. Furthermore, “[N]atural solution for Acne. Intended for use by teenagers who suffer from pimples, acne, oily, red, and sensitive facial skin.”; “[H]elps to rebuild the damaged skin tissues around the wound.”; “Rapid regeneration, suitable for recent scarring.” are not acceptable claims for the management or treatment of acne (21 C.F.R. 333.350(b)(2)).
 
Therefore, based on the non-monograph active ingredient and unacceptable claims, “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” is a new drug as defined by section 201(p) of the Act because we are not aware of sufficient evidence to show that it is generally recognized as safe and effective. Therefore, as presently formulated, labeled, and promoted, “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” is an unapproved new drug in violation of section 505(a) of the Act.
 
Under section 301(d) of the Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. “[M]oraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” does not have an approved application, and its introduction into interstate commerce violates these provisions of the Act.
 
In addition to new drug charges, moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” is misbranded under 502(a) of the Act because its labeling is misleading in that a disclaimer reads, “Statements on this website have not been evaluated by the FDA. No product is intended to treat, prevent or cure any disease.” However, as stated above, based on the labeling, “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” is a drug as defined by section 201(g)(1) of the Act because it is intended to treat a disease and to affect the structure or function of the body of man, and “moraz galilee medical herbs TEENAGE Polygonum Teenage Facial Cream” requires an FDA-approved application. 
 
Regarding the regulatory status of the Hairgane Hair Regrowth Treatment, the firm makes explicit hair growth claims ("Hairgane is mainly used for hair loss control, hair re-growth stimulation and follicle environment improvement.") for this product, which makes it a drug. Specifically, under 21 C.F.R. § 310.527 any OTC drug product that is labeled, represented, or promoted for external use as a hair grower or for hair loss prevention is regarded as a new drug within the meaning of section 201(p) of the Act. Therefore, Hairgane Hair Regrowth Treatment is a “new drug” marketed in the United States by Shaping Beauty, Inc. in violation of section 505 of the Act.
 
Additional Unapproved and Misbranded Drugs:

Based on a review of labeling of other products collected during our inspection and/or a review of your firm’s internet website at www.shapingbeauty.com, your products listed below, as well as other products you market on your website, are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of the disease claims on your product labels and/or on your internet web site include:
 
1.   Arava Tea DIABEtea (Tea Bags):
  • “Controls Blood Sugar Level”
  • “Diabetea … created by a doctor to help regulate levels of sugar in a body.”
2.   mlis FIBER Wheat Bran and Psyllium (capsules):
  •  “[H]elp lower cholesterol levels. . .”
  •   “Protect intestinal canal from putrefactive or pathogenic bacteria cancer-causing agent.” 
  •    “Lower the cholesterol and triglyceride levels in the body.”
  •   “Aid Diabetes, Ischemic Heart Disease, Gall Bladder Disorders, Varicose Veins, Diverticulitis, and Appendicitis.”
3.   mlis VITAL Antioxidant with Astaxanthin (capsules):
  •   “[H]as anti-cancer effects on human cells. Also prevents oxidative damage to blood LDL-cholesterol”
  •   “[C]an be used as a diuretic.”
  •   “Helps relieve the symptoms of hepatitis, cirrhosis, and inflammatory liver conditions.”
4.   mlis RELIEF Muscle & Joint Aid (capsules):
  •   “[A] natural treatment for arthritis, stiffness, swollen joints, and muscular aches and pains.”
  •  “Treats adrenal insufficiency.”
  •   “[U]sed for the treatment of arthritis, rheumatism, sciatica and lumbago.”
  •   “Useful in the treatment of gout, rheumatism, colds, fever, ringworm, and skin eruptions.”
5.   mlis EVENING PRIMROSE OIL (softgels):
  •   “Can improve blood lipid levels and decrease the risk of coronary heart disease. Can reduce the risk of sudden cardiac death”
  • “Alleviates the discomforts of PMS and eczema, breast pain and rheumatoid arthritis.”
  •  “May help: heart disease, lupus, osteoarthritis, rheumatoid arthritis, diabetes, eczema . . .”
Arava Tea DIABEtea, mlis FIBER Wheat Bran and Psyllium capsules, mlis VITAL Antioxidant with Astaxanthin capsules, mlis RELIEF Muscle & Joint Aid capsules, and mlis EVENING PRIMROSE OIL softgels are drugs, as defined by section 201(g)(1) of the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
 
Moreover, the above-listed products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Therefore, these products are new drugs under section 201(p) of the Act. Under sections 301(d) and 505(a) of the Act, a new drug may not be introduced of delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction or delivery for introduction into interstate commerce of your products, Arava Tea DIABEtea, mlis FIBER Wheat Bran and Psyllium capsules, mlis VITAL Antioxidant with Astaxanthin capsules, mlis RELIEF Muscle & Joint Aid capsules, and mlis EVENING PRIMROSE OIL softgels, without FDA-approved applications in effect for them, violates these provisions of the Act.
 
The above-listed products are misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fail to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 C.F.R. § 201.5]. These products are offered for conditions which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use the above-listed products safely for their intended uses. None of the above-listed products are exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that their labeling bear adequate directions for use because the products lack approved applications. For these reasons, Arava Tea DIABEtea, mlis FIBER Wheat Bran and Psyllium capsules, mlis VITAL Antioxidant with Astaxanthin capsules, mlis RELIEF Muscle & Joint Aid capsules, and mlis EVENING PRIMROSE OIL softgels are misbranded under section 502(f)(1) of the Act. Section 301(a) of the Act prohibits the introduction or delivery for introduction of misbranded drugs into interstate commerce.
 
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. 
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334].
 
We acknowledge that you state that you have discontinued the receipt and distribution of Celerite Slimming Capsules and Celerite Slimming Tea, and that your firm is cooperating with FDA by conducting a voluntary recall of these products. Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Additionally, if another firm manufactures these products, identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier, in addition to the manufacturer. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.   
 
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
 
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District
 
cc:       
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Acting Director
 
U.S. Drug Enforcement Administration
Attn:  Graziano Iezzi, Task Force Officer
William. J. Green Federal Building
600 Arch Street, Room 10224
Philadelphia, PA 19106