Inspections, Compliance, Enforcement, and Criminal Investigations

Rainbow Gold Products Inc 5/4/17

 

  

Black HHS-Blue FDA Logo

 

 

 
New Orleans District
404 BNA Drive
Building 200- Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802 

 

May 4, 2017
 
WARNING LETTER NO. 2017-NOL-08
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
George Dennis Boyette, President & Co-Owner
Rainbow Gold Products, Inc.
1610 Sardis Drive
Sardis City, Alabama 35956-2337
 
Dear Mr. Boyette:
 
On August 8, 9, and 11, 2016, investigators from the U. S. Food and Drug Administration (FDA) conducted an inspection of your drug repackaging and relabeling facility, Rainbow Gold Products, Inc., located at 1610 Sardis Drive, Sardis City, Alabama. The inspection revealed that Vopac MDS Anti-Inflammatory Management Kit with Metered Dose Spray System includes an unapproved new drug, and that Isometheptene-Dichloral-APAP and Vayarin are unapproved new drugs. Your firm introduces or delivers for introduction into interstate commerce these unapproved new drugs, in violation of Sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 United States Code (USC) 355(a) and 331(d)]. Furthermore, these drugs are misbranded under Section 502(f)(1) of the FD&C Act [21 USC 352(f)(1)], and by introducing or delivering these products for introduction into interstate commerce, you are in violation of Section 301(a) of the FD&C Act [21 USC n 331(a)].  These violations are concerning from a public health perspective because, among other reasons, the labeling of the drugs you introduced into interstate commerce do not provide adequate directions for their safe and effective use.   
 
Unapproved New Drug Violations
 
Vopac MDS Anti-Inflammatory Management Kit with Metered Dose Spray System includes, and Isometheptene-Dichloral-APAP and Vayarin are drugs within the meaning of Section 201(g)(1) of the FD&C Act [21 USC 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body of man or other animals. Labeling statements documenting the intended uses of your products include, but are not limited, to the following:
  • Vopac MDS Anti-Inflammatory Management Kit with Metered Dose Spray System (containing: diclofenac sodium topical solution 1.5% w/w, sterile alcohol prep swabs, HDPE bottle 6oz., meter dose spray cap, sterile latex gloves, CSR wrap), (NDC 51021-278-01), labeled with statement of intended use: “Treatment of signs and symptoms of osteoarthritis of the knee(s)”
  • Isometheptene-Dichloral-APAP (isometheptene 65 mg, dichloralphenazone 100mg, acetaminophen 325mg), (NDC 58657-401-01), labeled with statement of intended use: “Relief of tension and vascular headaches” 
  • Vayarin (lipirinen 167mg containing phosphatidylserine (PS) 75mg, eicosapentaenoic acid (EPA) 21.5mg, docosahexaenoic acid (DHA) 8.5mg), (75959-233), labeled with statement of intended use: “Clinical dietary management of complex lipid imbalances associated with ADHD in children.”
Furthermore, these drugs are “new drugs” within the meaning of Section 201(p) of the FD&C Act [(21 USC 321(p)] because they are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under Sections 301(d) and 505(a) of the FD&C Act [21 USC 331(d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an FDA approved application is in effect for the drug. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There are no FDA approved applications on file for the drugs listed above. The introduction or delivery for introduction of these drugs, or other new drugs, into interstate commerce without an approved application constitutes a violation of these provisions of the FD&C Act.
 
Misbranding Violations
 
Under Section 502(f)(1) of the FD&C Act [21 USC 352(f)(1)], a drug is misbranded if, among other things, its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended ([21 Code of Federal Regulations (CFR) 201.5]. “Prescription drugs,” as defined in Section 503(b)(1) of the FD&C Act [(21 USC 353(b)(1)], are drugs, because of their toxicity or potential for harmful effect, method of use, or collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. It is impossible to write adequate directions for use for prescription drugs because prescription drugs can only be used safely under the supervision of a practitioner licensed by law to administer them.
 
Vopac MDS Anti-Inflammatory Management Kit with Metered Dose Spray includes, and Isometheptene-Dichloral-APAP and Vayarin are drugs, due to their toxicity or potential for harmful effects and the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Thus, they are “prescription drugs,” as defined in Section 503(b)(1) of the FD&C Act [21 USC 353(b)(1)], and adequate directions cannot be written so that a layman can use them safely for their intended uses. Consequently, the labeling of these drugs fails to bear adequate directions for their intended uses, causing them to be misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of a misbranded drug violates Section 301(a) of the FD&C Act [21 USC 331(a)].
 
Registration and Listing
 
A review of the listing for Vopac MDS Anti-Inflammatory Management Kit with Metered Dose Spray System (NDC 51021-278-01) reveals the submitted listing information includes an application number that does not refer to the listed product.
 
Conclusion
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. 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. 
 
You should take prompt action to review all your products and their associated labeling for claims that may be in violation of the FD&C Act. It is your responsibility to assure compliance with all requirements of federal law, including 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. You should discontinue distributing all of your firm’s unapproved drugs immediately.
 
Other federal agencies may take this warning letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected.  FDA may re-inspect to verify corrective actions have been completed.
 
All firms are required to electronically update the listing of their products under Section 510(j) of the FD&C Act to reflect the discontinuation of all drugs, including unapproved products [21 CFR 207.57(b)(1)(ii)]. Questions about the electronic drug listing updates should be sent to eDRLS@fda.hhs.gov. FDA plans to rely on its existing records, including its drug listing records, the results of future inspections, or other available information when considering enforcement action.
 
Within 15 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 the related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the date by which you will have completed the corrections. 
 
Please send your reply to:  Mark W. River, Compliance Officer, Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have questions regarding any issues in this letter, please contact Mr. Rivero at 504-846-6103.
 
Sincerely,
/S/ 
Ruth P. Dixon
District Director
New Orleans District
 

Page Last Updated: 05/08/2017
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