Inspections, Compliance, Enforcement, and Criminal Investigations

Infiniti Creations Inc 2/26/15

  

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

Public Health Service
Food and Drug Administration
 Silver Spring, MD 20993-0002

 

February 26, 2015
 
 
WARNING LETTER
 
 
Brian E. Brown
CEO/Owner
Infiniti Creations, Inc.
1453 W 40 S
Suite 200
Lindon, UT 84042
                                                                                    
Dear Brian E. Brown:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the information on your website www.curadermcream.com (redirected to: www.bec5creamdirect.com) and determined that your products “Curaderm BEC 5 Cream” and “Tamanu Oil” are marketed in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as detailed below. 
 
“Curaderm BEC 5 Cream” and “Tamanu Oil” are drugs as defined by section 201(g)(l) of the
FD&C Act [21 U.S.C. § 321(g)(l)], because they are intended to prevent, treat, or cure disease
conditions and/or affect the structure or function of the body. Labeling statements documenting the intended uses of these products include, but are not limited to, the following:
 
“Curaderm BEC 5 Cream”
 
“[U]sed on non-melanoma skin lesions, including the two most common types of skin lesions, basal cell carcinoma and squamous cell carcinoma.”
 
“Clinically proven to eliminate non-melanoma skin lesions, including actinic keratosis, sunspots, basal cell carcinoma and squamous cell carcinoma.”
 
“Non-invasive compared to surgery.”
 
“Tamanu Oil”
 
“[B]elieved to have wonderful skin healing, anti neuralgic [sic], anti-inflammatory, antimicrobial, antibiotic, and antioxidant properties.”
  
“Curaderm BEC 5 Cream” and “Tamanu Oil” are new drugs under section 20l(p) of the FD&C Act [21 U.S.C. § 321(p)] because the products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. Under sections 30l(d) and 505(a) of the FD&C 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 “Curaderm BEC 5 Cream” and “Tamanu Oil” without an approved application violates these provisions of the FD&C Act.
 
Furthermore, your “Curaderm BEC 5 Cream” and “Tamanu Oil” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use the products safely for their intended purposes. Thus, your products’ labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of a misbranded drug is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your website and product labels. 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 ensure that your firm complies with the FD&C Act and applicable 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/or injunction.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the 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 actions within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:
 
U.S. Food and Drug Administration                                           
CDER/OC/OUDLC
10903 New Hampshire Avenue, WO51
Silver Spring, MD 20993-0002
 
Sincerely,
                                                                   
/s/
  
Cynthia Schnedar, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research

 

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