Inspections, Compliance, Enforcement, and Criminal Investigations

Dolgencorp Inc 9/19/13


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

Public Health Service
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802 


September 19, 2013
Delivery Signature Requested
Todd Vasos, CEO
Dolgencorp, Inc.
100 Mission Ridge
Goodlettsville, Tennessee 37072-2171
Dear Mr. Vasos:
This letter is to advise you the United States Food and Drug Administration (FDA) has recently reviewed your firm’s labeling and marketing information for the drug product, “Rexall Earache Relief Drops.” Based on our review, the product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, this product is misbranded under Sections 502 and 503 [21 United States Code (USC) 352 and 353] and in violation of Section 301 of the Act [21 USC 331].
The label, website, and other labeling demonstrate the intended uses of your product including, but not limited to, the following:
  • The product name, “Rexall Earache Relief Drops”
  • “Mercurius Solubilis . . . This ingredient addresses inflammation and pain in the inner ear”
  • “Relieves pain”
  • “[T]emporary relief from symptoms of earache . . .”
  • “[S]timulate the human body’s ability to ease ear pain”
Based on these claims, your product is a drug, as defined by Section 201(g)(1)(B) and (C) of the Act [21 USC 321(g)(1)(B) and (C)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and/or intended to affect the structure or any function of the body.
Although marketed to consumers as an over-the-counter (OTC) drug, Rexall Earache Relief Drops is a prescription drug under Section 503(b)(1) of the Act [21 USC 353(b)(1)]. Section 503(b)(1) of the Act [21 USC 353 (b)(1)] identifies criteria for determining the prescription status of a product. The product listed above is a prescription drug within the meaning of Section 503(b)(1) of the Act because it is intended to treat diseases that requires diagnosis and treatment by a physician or is intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Ear pain (earache) is not a currently recognized OTC indication in the final monograph for topical otic drug products (21 CFR 344) or in any approved OTC new drug application. [1]OTC treatment is inappropriate for ear pain because consumers cannot distinguish its symptoms from those of more serious disorders of the ear or adjacent tissues which are not amenable to OTC treatment and which can lead to serious injury if not accurately diagnosed and treated by a licensed healthcare professional. 
Because this product is subject to 503(b)(1) of the Act, the product is misbranded under Section 503(b)(4) of the Act [21 USC 353(b)(4)] because the label fails to bear the symbol, “Rx only.”[2]
Rexall Earache Relief Drops is also misbranded within the meaning of Section 502(f)(1) of the Act [21 USC 352(f)(1)] because its labeling fails to bear adequate directions for use as that term is defined in 21 Code of Federal Registration Part 201.5. The indication for which the product listed above is labeled and marketed, i.e., treatment of ear pain or inflammation, is not appropriate for OTC use. If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication. 
Furthermore, the drug is misbranded within the meaning of Section 502(a) of the Act [21 USC 352 (a)] because its labeling is false or misleading because it represents the product as suitable for use by consumers to treat a condition which the Agency has found not appropriate for OTC drug treatment, and because it encourages OTC treatment for ear pain, but fails to distinguish among conditions that manifest with ear pain and that can lead to serious injury if not accurately diagnosed and treated by a licensed physician.
Your marketing of this misbranded product violates Sections 301(a) of the Act [21 USC 331(a)].
We recognize your product is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. The definition of “drug” in Section 201(g)(1) of the Act [21 USC 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed. Thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with Section 503(b) of the Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
The violations cited in this letter are not intended to be an all-inclusive statement of violations 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 or the occurrence of other violations. It is your responsibility to assure 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 that 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. 
Your response should be sent to Mr. Mark W. Rivero, Compliance Officer at the above address.  If you have any questions about the content of this letter please contact Mr. Rivero at (504) 832-1290, extension 1103.
Patricia K. Schafer
District Director
New Orleans District

[1] The question of whether a product intended to treat ear pain should be available by prescription only or OTC is governed by § 503(b) of the FD&C Act, to which all homeopathic drug products are subject. Accordingly, the Agency’s conclusion that treatment or relief of ear pain is not an appropriate OTC indication is applicable to both homeopathic and non-homeopathic drugs marketed for that indication. 
[2] The Agency's guidance, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15),” states that, in accordance with § 503(b)(1) of the FD&C Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, “Caution:  Federal law prohibits dispensing without prescription.”  This guidance was issued by the Agency in 1988.  In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); Section 126 of FDAMA amended § 503(b)(4) of the FD&C Act to require that the label of a prescription drug must bear, at a minimum, the symbol “Rx only.”

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