WARNING LETTER
Infant Acid Reflux Solutions LLC
MARCS-CMS 539232 —
February 05, 2018
Recipient:
Infant Acid Reflux Solutions LLC
United States
Issuing Office:
Los Angeles District Office
United States
Division of Pharmaceutical Quality Operations IV
19701 Fairchild, Irvine, CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417
WARNING LETTER
VIA SIGNATURE CONFIRMED DELIVERY
February 5, 2018
Kira Volpi, Owner
Infant Acid Reflux Solutions
6709 W 119
th
St
Overland Park, KS 66208
(b)(6)
Dear Ms. Kira Volpi:
This is to advise you that the United States Food and Drug Administration (FDA) has reviewed the information on your website http://www.infant-acid-reflux-solutions.com/ and determined that your product “TummyCare Max” for infant gastroesophageal reflux is marketed in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as detailed below.
Unapproved New Drug Violations
Your product “TummyCare Max” is a drug within the meaning of section 201(g)(1) of the FD&C Act. Under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)], drugs are defined to include “articles (other than food) [that are] intended to affect the structure or . . . function of the body.” The intended use of an article may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution per 21 C.F.R. § 201.128. Your website [http://www.infant-acid-reflux-solutions.com/] for “TummyCare Max” includes claims that describe the intended uses of the product, such as the following:
“TummyCare Max can be used by itself (without mixing it together with a PPI) as an antacid.”
“. . . can be useful for breakthrough acid reflux, also for weaning off of a PPI.”
“Each packet, mixed with a PPI such as omeprazole or lansoprazole, can provide you with seven to thirty days of infant acid reflux treatment . . ..”
“It makes the PPI more palatable and protects them from stomach acid.”
“When a PPI is compounded with our product it will become an immediate release PPI rather than a delayed release. That means more rapid absorption of the PPI.”
“Works with PPI’s (proton pump inhibitors) such as omeprazole or lansoprazole, whether it is over the counter or Rx (Under the supervision of your medical care team).”
Moreover, the product is a “new drug,” as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321 (p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.
The introduction or delivery for introduction, or causing the introduction or delivery for introduction, of a new drug lacking an FDA-approved new drug application (NDA) is a violation of sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 33 1(d) and 355(a)]. Your sale of the new drug “TummyCare Max” without an approved NDA violates these provisions of the FD&C Act.
Misbranded Drug Violations
Furthermore, your product is a “prescription drug” as defined at section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], in that, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Specifically, medical expertise is needed to diagnose infant gastroesophageal reflux, order clinical tests as needed to confirm the diagnosis (e.g., upper gastrointestinal (GI) tract contrast radiography, esophageal pH and/or impedance monitoring, and upper endoscopy with esophageal biopsy), and to determine the most appropriate therapeutic intervention(s) for the individual patient (e.g., feeding and positioning changes, changes to maternal diet for nursing infants, initiation of acid suppressants and prokinetic pharmacologic agents). In addition to these collateral measures, there are “potentialities for harmful effects” associated with the use of this product when combined with PPIs in infants, including increased susceptibility to acute gastroenteritis and community-acquired pneumonia.
According to section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended per 21 C.F.R. § 201.5. Because, by definition, prescription drugs can only be used safely under the supervision of a licensed practitioner, adequate directions cannot be written so that a layperson can use them safely for their intended uses. 21 U.S.C. § 353(b). Consequently, the product labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1). 21 U.S.C. § 352(f)(1).
FDA has exercised its authority under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] to create regulatory exemptions from the requirements of section 502(f)(1) [21 U.S.C. § 352(f)(1)].
However, because your firm’s “TummyCare Max” product lacks the required approved new drug application, it is not exempt under 21 C.F.R. § 201.115 from the requirement to bear adequate directions for use under section 502(f)(1) of the FD&C Act. Therefore, the product is misbranded, and the introduction or delivery for introduction, or causing the introduction or delivery for introduction, into interstate commerce of this misbranded drug violates 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 statement of violations that exist in connection with your products. 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 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. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Address your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
United States Food and Drug Administration
19701 Fairchild
Irvine, California 92612-2506
If you have any questions regarding any issues in this letter, please contact Lance M. De Souza, Compliance Officer,
via email to
lance.desouza@fda.hhs.gov
or by phone at (510) 337-6873 and reference unique identifier
539232
.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
05/15/2018