| Public Health Service Food and Drug Administration |
| Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax (949) 608-4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
August 4, 2011
Mr. Dino R. Guglielmelli, President/CEO
Creation’s Garden Natural Products, Inc. WL 49-11
24849 Anza Drive
Valencia, CA 91355
Dear Mr. Guglielmelli:
The U.S. Food and Drug Administration (FDA) has reviewed your website at the internet address, www.creationsgarden.com in July 2011 and has determined that the products Cardio Health, Prostate Factors, Natural Science Glucosamine Chondrotin Complex with MSM, Natural Science MSM with Vitamin C, Joint Maintenance beverage, Gogi Berry Juice, and Mangosteen juice are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease or affect the structure or function of the body. The marketing of the products with these claims violates the Act. The Act and its implementing regulations can be found at www.fda.gov.
Examples of some of the claims found on your website include:
Tablets
Prostate Factors
- “Reduces Enlarged Prostate”
- “Reduces Elevated PSA”
Cardio Health
- “Reduces Angina or Chest Pain”
- “Decrease Cholesterol”
- “Reduces Incidence of Heart Disease”
Natural Science for Athletes
Glucosamine Chondrotin Complex with MSM
- “Excellent Anti-inflammatory”
- “Joints, Knees and Hip Repairer”
MSM with Vitamin C
- “Excellent Anti-inflammatory”
- “Joints, Knees and Hip Repairer”
- “Effective for treatment of allergies, arthritis, rheumatism, joint and ligament injuries….”
Beverages
Joint Maintenance
- “Anti-inflammatory …”
- “Reduces Joint Pain”
- “Accelerated Joints, Knees and Hip Repair”
- “Prevents … Bone Spurs”
Goji Berry Juice
- “Goji berries…protect the liver ... eyesight ...sexual function and fertility ....”
- “A Chinese study published in the Chinese Journal of Oncology in 1994 found that 79 people with cancer responded better to treatment when goji was added to their regimen.”
- “[G]oji extracts may prevent the growth of cancer cells….”
Mangosteen Juice
- “Mangosteen is very high in antioxidants and xanthones . Laboratory studies suggest xanthones have anti-cancer effects when they are studied in test tubes. Mangosteen has also been found to have anti-inflammatory, antimicrobial, antifungal, and antiseptic properties in test tube studies.”
- “[M]angosteen fruit which are said to reduce cholesterol levels and hardening of the arteries, or atherosclerosis, as well as natural anti-carcinogenic.”
Your products, as noted above are not generally recognized as safe and effective for the above referenced uses; therefore, these products are “new drugs” under Section 201(p) of the Act [21 USC § 321(p)]. Under Section 301(d) and 505(a) of the Act [21 USC §§ 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 introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Furthermore, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because the product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the product safely for its intended uses. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include, but is not limited to, seizure and/or injunction.
In addition, we have the following comment:
Your firm’s websites, www.creationsgarden.com and www.cgnp.net, and letterhead make 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.
Please advise this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Your response should be sent to:
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Marco S. Esteves, Compliance Officer, at 949-608-4439.
Sincerely,
/S/
Alonza E. Cruse
District Director
Cc:
Ingeborg Small, Branch Chief
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
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