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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dynamic Nutritional Associates 11/6/09

   

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

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996


November 6, 2009


VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED


In reply refer to Warning Letter SEA 10-06


Dale H. Grose, President
Dynamic Nutritional Associates
19456 State Road 971
Chelan, Washington 98816


WARNING LETTER


Dear Mr. Grose:


This letter is to advise you that the United States Food and Drug Administration (FDA or Agency) has reviewed your firm's website and online product catalog at www.dnalabsinc.net. FDA also reviewed your firm's labeling and marketing information for products including: D-17 Tumorell, D-24 Pneumell, D-33 Spasmonell, D-40 Peranemiol, D-46 Goutinol, D-48 Pulmonon, and D-62 Rubilin. Based on our review of your website, including your online product catalog, and the labeling for these products, these products are misbranded under sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 353 and 331), as described below.


Products and associated statements on the immediate container labels that document the intended uses of your products include, but are not limited to the following:


D-17 Tumorell: "INDICATIONS: ... growths ... and tumors"
D-24 Pneumell: "INDICATIONS: Pleurisy, intercostal neuralgia"
D-33 Spasmonell: "INDICATIONS: Epilepsy"
D-40 Peranemiol: "INDICATIONS: Diabetes"
D-46 Goutinol: "INDICATIONS: Gout and rheumatism"
D-48 Pulmonon: "INDICATIONS: Pulmonary disorders"
D-62 Rubilin: "INDICATIONS: Measles"


In addition to the above regarding the intended uses of these products, your product catalog makes additional statements regarding the products' intended uses including, but not limited to:


D-17 Tumorell: "Regenerator of diseased tissue, (tuberculous ulceration). Growths and eczema affecting external and internal organs. Inflammatory and trophic rashes. Anomalous
epithelial growths ... "
D-24 Pneumell: "Pleurisy, intercostal neuralgia pleurodynia, pneumonia and intercostal rheumatism."
D-33 Spasmonell: "Epilepsy and epileptic fits, ... convulsions, chorea minor, convulsive cramps"
D-40 Peranemiol: "Diabetes, pernicious anemia and phases of degeneration in the blood and glandular system, such as leukemia, anemia, lymphogranulomatosis."
D-46 Goutinol: "Rheumatism of forearms and hands, gout, swollen joints, numbness."
D-48 Pulmonon: "Pulmonary and tuberculous diseases. ... chronic pulmonary catarrh ... ".
D-62 Rubilin: "Measles, German measles."


Based on the above labeling and claims, these products are drugs under section 201 (g)(1)(B) of the Act (21 U.S.C. § 321 (g)(1)(B)), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and under section 201 (g)(1)(C) of the Act (21 U.S.C. § 321 (g)(1)(C)), because they are intended to affect the structure or any function of the body.


Section 503(b)(1) of the Act (21 U.S.C. 353(b)(1)) identifies criteria for determining the prescription status of a product. The products listed above are prescription drugs within the meaning of section 503(b)(1) of the Act because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician.


Because they may be dispensed only by prescription of a licensed practitioner, these products are misbranded under section 503(b)(4) of the Act (21 U.S.C. § 353(b)(4)) in that their labels fail to bear the symbol, "Rx only."1 Your marketing of these misbranded products violates sections 301(a) and (k) of the Act (21 U.S.C. §§ 331 (a) and (k)).


We recognize that these products are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths.2 The definition of "drug" in section 201 (g)(1) of the Act (21 U.S.C. § 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 that 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. 3


The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 corrections.


Furthermore, please advise this office of what actions you will take to address product that you, have already distributed.


Address your reply to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 483-4940.

 

Sincerely, 

/S/

Charles M. Breen

District Director

 

1 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 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 Act to require that the label of a prescription drug must bear the symbol "Rx only."


2 For example, the label for D-62 Rubilin includes the ingredients Arum triphyllum 3x, Belladonna 4x, Ferrum phosphoricum 8x, Mercurius solubilis 8x, and Pulsatilla 4x.


3 We note that the CPG also states that, if the HPUS specifies a distinction between nonprescription (OTC) and prescription status of a product based on strength (e.g., 30X), and that distinction is more restrictive than section 503(b) of the Act, the more stringent criteria (i.e., the HPUS criteria) will apply. It follows from this that, if the HPUS specifies a distinction between OTC and prescription status based on strength, and that distinction is less restrictive than section 503(b) of the Act, the section 503(b) criteria will apply regardless of the HPUS distinction.