Seattle District Office
22215 26th Ave. SE, Ste. 210
Bothell, WA 98021 

 

December 1, 2016
 
                                                                                   
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 17-04
 
Robert G. Thompson, M.D., President
Aurora Health and Nutrition
188 West Marydale Avenue
Soldotna, Alaska 99669
 
WARNING LETTER
 
Dear Dr. Thompson:                                                                                   
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your web site at www.aurorahealthandnutrition.com from which you take orders for the following products: 5-HTP, Alpha Lipoic Acid, the Argentyn 23 product line, Artecin 90 Vegetarian Capsules, ChromeMate GTF 600, Cold Sore Rescue, Curcumin, Myomin, and Ozonated Olive Oil. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act).  You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Unapproved New Drugs and Misbranded Drugs
 
Based on the labeling claims on your website, your marketed products, the Argentyn 23 product line, Artecin 90 Vegetarian Capsules, and Ozonated Olive Oil, are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.
 
Examples of some of the labeling claims that provide evidence that your products are intended for use as drugs on your website include, but may not be limited to, the following:
 
Argentyn 23, 4 oz.
Argentyn 23, 8 oz.
Argentyn 23, 16 oz.
Argentyn 23, 2 oz. dropper
Argentyn 23, 2 oz. vertical spray
Artecin 90 Vegetarian Capsules
Ozonated Olive Oil
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].  It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Unapproved New Drugs and Misbranded Drugs Marketed as Dietary Supplements
 
Based on the labeling claims on your website, your products marketed as dietary supplements, 5-HTP, Artecin 90 Vegetarian Capsules, Alpha Lipoic Acid, ChromeMate GTF 600, Curcumin, and Myomin, are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
 
Examples of such disease claims found in the labeling of these products include, but may not be limited to, the following:
 
5-HTP
Artecin 90 Vegetarian Capsules
Alpha Lipoic Acid
ChromeMate GTF 600 
Curcumin
Myomin
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].  It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Misbranded Homeopathic Drug
 
According to the labeling claims on your website, your product Cold Sore Rescue is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  Examples of some of the labeling claims establishing the intended use of Cold Sore Rescue include, but may not be limited to, the following:
Section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)] identifies criteria for determining the prescription status of a product.  Your product Cold Sore Rescue is a prescription drug within the meaning of section 503(b)(1) of the Act, because it is intended to treat a disease (genital herpes) 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.  Because it is subject to § 503(b)(1) of the Act, Cold Sore Rescue is misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)] in that its label fails to bear the symbol “Rx only.” [1]  It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the Act [21 U.S.C. § 331(a)]. 
 
Genital herpes is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.  “Adequate directions for use” is defined in 21 CFR § 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended.”  Because this condition requires the supervision of a practitioner licensed to prescribe drugs, adequate directions cannot be written so that a layperson can use your product safely for this indication.  Thus, your product’s labeling fails to bear adequate directions for use for this indication, which causes the product to also be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. 
 
The labeling for Cold Sore Rescue includes claims for the treatment of genital herpes, as noted above.  A consumer who uses this product as labeled may forgo or delay consultation with a licensed practitioner and treatment as suggested by such a licensed practitioner, which can be dangerous not only to the consumer, but also to the consumer’s sexual partners.  This product is therefore dangerous to health and misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)]. 
 
We recognize that Cold Sore Rescue is represented as being a homeopathic drug with active ingredients measured in homeopathic strengths.  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 Pharmacopoeia 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, “CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed” (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 over-the-counter (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 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 assure that you comply 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 (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 actions 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 U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Patricia A. Pinkerton, Compliance Officer. Refer to the identification number WL SEA 17-04 when replying. If you have any questions with regard to this letter, please contact Compliance Officer Patricia Pinkerton by telephone at 425-302-0428.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
cc: Executive Administrator
State Medical Board
Department of Commerce, Community, and Economic Development
550 West 7th Avenue, Suite 1500
Anchorage, AK 99501-3567
 
Alaska Department of Environmental Conservation
Division of Environmental Health, Food Safety and Sanitation
555 Cordova Street
Anchorage, Alaska 99501-2617
 
Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue NW
Washington, D.C. 20580


[1] The Agency’s Compliance Policy Guide (CPG) , “CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed,” 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 CPG 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, at a minimum, the symbol “Rx only.”

This page was posted on August 11, 2017.

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