Inspections, Compliance, Enforcement, and Criminal Investigations

SCS Direct Inc. 10/18/16

  

Department of Health and Human Services logo

 New England District Office
One Montvale Avenue
Stoneham, MA 02180

 

WARNING LETTER
CMS # 495961
 
 
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
October 18, 2016
 
Howard Greenspan, President
SCS Direct Inc.
Holding Company of MD MOM® LLC.
9 Trefoil Dr.
Trumbull, CT 06611-1330
 
Dear Mr. Greenspan,
 
This letter concerns your firm’s marketing of your over-the-counter (OTC) drug product “MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30.”
 
As described below, “MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF 30” is an unapproved new drug because the product is ineligible for the over-the-counter (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 MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30” may not help protect consumers from sunburn and may cause users to be susceptible to sunburn and other disease conditions.
 
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)]. 
 
Unapproved New Drug Charge
 
“MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30” is labeled “Helps prevent sunburn.” Based on this labeling, MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under 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 of man. Specifically, this product is intended for use to help provide protection from sunburn.
  
Based on the claims made for your product, “MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30” 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 also 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 towelettes and wipes are currently ineligible for the OTC Drug Review for Sunscreens because FDA is not aware of evidence that a sunscreen in a towelette or 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 these dosage forms 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 these dosage forms 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(a)] 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 “MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30” for OTC use to help prevent sunburn. Therefore, this product 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 “MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30.” 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 “MD MOM® Babysafe Sunscreen Towelettes Broad Spectrum SPF30,” and provide the date(s) and reason(s) you ceased production. Your written notification should refer to the Warning Letter Number above (CMS# 495961). Please address your reply to Compliance Officer Rory Geyer, at the address above.
 
If you have questions regarding the contents of this letter, please contact Compliance Officer Rory Geyer at 781-587-7521 or rory.geyer@fda.hhs.gov.
 
 
 
Sincerely,
/S/
Lori A. Holmquist
Acting District Director
New England District
 
 
cc:
               
CAPT Steven E. Porter, Jr.
District Director
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
Diane Truong, M.D. 
JJ Levenstein, M.D.
MD Essentials Inc. dba MD Mom (“Corporate Headquarters”)
19051 Goldenwest, Suite 106-136
Huntington Beach, CA 92648
 
Diane Truong, M.D. 
JJ Levenstein, M.D.
MD Essentials dba MD Mom
19600 Cloverwood Circle
Huntington Beach, CA 92648


[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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