Inspections, Compliance, Enforcement, and Criminal Investigations

Diamond Wipes International, Inc. 10/19/16

  

Department of Health and Human Services logo

 Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

 

WARNING LETTER
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
October 19, 2016
WL # 03-17
Ms. Eve Yen
Owner and President
Diamond Wipes International, Inc.
4651 Schaefer Avenue
Chino, CA 91710
 
Dear Ms. Yen:
 
During an inspection (October 20 to November 2, 2015) of your pharmaceutical manufacturing facility, Diamond Wipes International, Inc., at 4651 Schaefer Avenue, Chino, CA, an investigator from the Food and Drug Administration (FDA) collected labels and labeling for the following nonprescription (over-the-counter (OTC)) drug manufactured at your firm, “LA FRESH travel-lite Sunscreen Wipe SPF 30.”  
 
As described below, this product is an unapproved new drug. Your firm’s introduction of this unapproved new drug into interstate commerce is in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(d) and 355(a)].
 
LA FRESH travel-lite Sunscreen Wipe SPF 30
 
Unapproved New Drug Charge
 
“LA FRESH travel-lite Sunscreen Wipe SPF 30” is an unapproved new drug because the product is ineligible for the OTC Drug Review for Sunscreens, it is not generally recognized as safe and effective for use to help provide protection from sunburn, and we are not aware of an FDA-approved application on file for this product. As such, the use of “LA FRESH travel-lite Sunscreen Wipe SPF 30” may not help protect consumers from sunburn and may cause users to be susceptible to sunburn and other disease conditions.
 
“LA FRESH travel-lite Sunscreen Wipe SPF 30” is labeled “helps prevent sunburn.” Based on its labeling, “LA FRESH travel-lite Sunscreen Wipe SPF 30” is a “drug” as defined by section 20l(g)(l)(B) of the FD&C Act [21 U.S.C. § 321(g)(l)(B)], because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or as defined by section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)] because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use to help prevent sunburn.  
 
Based on the claims made for this product, “LA FRESH travel-lite Sunscreen Wipe SPF 30” is a "new drug" within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because it has not been used to a material extent or for a material time for its labeled use to help prevent sunburn, and because it is not generally recognized as safe and effective for that use. The newness of a drug may arise, among other reasons, by reason of the newness of a dosage or method or duration of administration or application [see 21 CFR 310.3(h)(5)]. 
 
As the Agency specifically noted in 2011, nonprescription drug products intended for use to help prevent sunburn that are marketed in dosage forms including wipes are currently ineligible for the OTC Drug Review for Sunscreens because FDA is not aware of evidence that a sunscreen in a wipe dosage form existed in the OTC drug marketplace on or before May 1972 (76 FR 35669 at 35671, June 17, 2011). In addition, OTC sunscreen products in this dosage form have not established eligibility for review under the Time and Extent Application (TEA) process (21 CFR 330.14(c)) or under the procedure set out in the Sunscreen Innovation Act (SIA) (21 U.S.C. 360fff), because we have not received any TEAs or requests for review under the SIA for these products. OTC sunscreen products in this dosage form that are marketed without an approved application therefore remain subject to regulatory action unless and until the requirements of the SIA or 21 CFR 330.14(h) are satisfied.[1]
 
Under sections 301(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 application approved by FDA and submitted under section 505(b) or 505(j) of the FD&C Act [21 U.S.C. § 355(b) or 355(j)] is in effect for the product. Without such an application, there is a lack of adequate data to establish eligibility of or general recognition of the safety and effectiveness of “LA FRESH travel-lite Sunscreen Wipe SPF 30” for OTC use to help prevent sunburn. Therefore, these products may not help protect consumers from sunburn, and may cause consumers to be susceptible to sunburn and other disease conditions caused by the sun. Based on our information, there is no FDA-approved application on file for “LA FRESH travel-lite Sunscreen Wipe SPF 30.” The marketing of this product without an approved application violates these provisions of the FD&C Act.
 
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance 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. 
 
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 and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute any of the drug products manufactured at this facility, and provide the date(s) and reason(s) you ceased production.
 
Your written reply should be addressed to:
 
Kelly D. Sheppard, Director
Compliance Branch
U.S. Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, California 92612-2506
 
 
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Los Angeles District Director
                                                        
 
Cc:      
David M. Mazzera, Ph.D.
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413


[1] For general information on the Agency’s proposed approach to the enforcement of nonprescription sunscreen products marketed without approved applications see Draft Guidance for Industry: Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application , available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm259001.pdf (published for notice and comment purposes only).

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