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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Naprodis, Inc. 4/17/12

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone:      949-608-2900
FAX:    949-608-4415

 

 
 
WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
W/L 23-12
April 13, 2012    
 
Paul F. Petit, President
NAPRODIS, Inc.
13250 Gregg St,
Poway, CA, 92064-7164
 
Dear Mr. Petit:
 
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, NAPRODIS, Inc, located at 13250 Gregg St, Poway, California, on November 8 through 22, 2011. During the inspection, our investigator also collected labeling for your products. FDA has reviewed this labeling, including your product labels and, in March 2012, your websites at the following internet addresses: http://www.naprodis.com, http://www.aromune.com, and http://www.aromune.com.  Based on this review, FDA has determined that your Phybiosis Aromune, Kinarome Oregano Oil, and Kinarome PMS & Menopause Synergy products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on your labeling and websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act.You can find the Act and implementing regulations on FDA's website at http://www.fda.gov.
 
Examples of some of the claims observed on your product labels are as follows:
 
Phybiosis AROMUNE, Medicinal Aromatic Solution:
 
  • “Taken orally, a potent and effective medicinal aromatic tonic for the immune system. Contains a synergistic blend of certified organic essential oils selected for their anti-infectious properties…”
 
Kinarome Oregano Oil:
 
  • “[F]or bacterial, viral, fungal, and parasitic infections.”
  • “Particularly useful for foot or nail fungus.”
  • “Powerful broad-spectrum, anti-infectious agent.”
  • “Especially useful for traveler’s diarrhea, food poisoning, yeast, respiratory & sinus infections.”
 
Kinarome PMS & Menopause Synergy:
 
  • “Essential oils in the PMS synergy have… analgesic and antifungal effects.”
 
Examples of some of the claims observed on your website http://www.naprodis.com are as follows:
 
Kinarome Oregano Oil page:
 
  • “Oregano Oil is one of the best preventive and proactive measures you can take for a broad range of chronic and acute conditions…INTERNAL USE: Take 3-6 drups in a capsule, water or juice 3 times per day. Powerful broad-spectrum, anti-infectious agent…[e]specially useful for traveler’s diarrhea, food poisoning, yeast, respiratory & sinus infections.”
 
Phybiosis AROMUNE page:
 
  • “[O]ffers the effectiveness of common anti-infectious agents …”
  • “[A] potent synergy of anti-infectious essential oils...”
  • “Primary essential oils are strongly anti-infectious. They act aggressively on bacteria, fungus, virus and parasites.”
  • “Secondary essential oils are highly anti-infectious, and carry a broader spectrum on anti-microbial activity. They serve to support anti-infectious activity and add a strongly anti-viral component to the formula.”
  • “Tertiary essential oils … show[] broad anti-infectious and antiviral activity.”
 
Examples of some of the claims observed on your website http://www.aromune.com are as follows:  
 
  • “[Phybiosis] AROMUNE™ is a potent synergy of highly anti-infectious essential oils…”
  • “Essential oils have been scientifically tested and proven to be efficient in combating infection…”
  • “Given the slow but irreparable deterioration of the penicillin empire, it has turned out that essential oils are the more reliable solution after all…”
  • “[A]uthentic essential oils show… tremendous anti-infectious properties.”
  • “Primary essential oils are strongly anti-infectious. They act aggressively on bacteria, fungus, virus and parasites.”
  • “Secondary essential oils are highly anti-infectious, and carry a broader spectrum on anti-microbial activity. They serve to support anti-infectious activity and add a strongly anti-viral component to the formula.”
  • “Tertiary essential oils … show[] broad anti-infectious and antiviral activity.”
 
Phybiosis Presentation Catalog 2009:
 
Aromune, pages 6 -7:
 
  • “[O]ffers the effectiveness of common anti-infectious agents…”
  • “Given the slow but irreparable deterioration of the penicillin empire, it has turned out that essential oils are the more reliable solution after all…”
  • “[A]uthentic essential oils show… tremendous anti-infectious properties.”
  • “Primary essential oils are strongly anti-infectious. They act aggressively on bacteria, fungus, virus and parasites.”
  • “Secondary essential oils are highly anti-infectious, and carry a broader spectrum on anti-microbial activity. They serve to support anti-infectious activity and add a strongly antiviral component to the formula.”
  • “Tertiary essential oils … show[] broad anti-infectious and antiviral activity.”
 
KINAROME Product Brochure:
 
Oregano Oil:
 
  • “Extensive clinical research as well as anecdotal and historical evidence has proven Oregano Oil to have powerful morphine-like anti-inflammatory and antibiotic (antibacterial, antifungal, antiviral and anti-parasitic) effects without the side effects of pharmaceutical drugs. Moreover, it has been shown to be effective against even drug-resistant bacteria…”
  • “[I]t is effective for a wide range of infections including gums, sinus, respiratory, intestinal (traveler’s diarrhea), yeast, food poisoning and latent viruses.”
  • “Powerful broad-spectrum, anti-infectious agent.”
  • “Especially useful for traveler’s diarrhea, food poisioning, yeast, respiratory & sinus infections.”
 
PMS & Menopause Synergy:
 
  • “[C]linical studies reveal that phyto-estrogens, even at very low concentrations, are hormone regulating and, by occupying estrogen receptor sites, are effective in inhibiting breast tumors and display other anti-cancer mechanisms with no side effects.”
  • “Essential oils in the PMS synergy have… analgesic and antifungal effects.”
 
Your products Phybiosis Aromune, Kinarome Oregano Oil, and Kinarome PMS & Menopause Synergy are not generally recognized as safe and effective for the above referenced uses and, therefore, they are also new drugs under section 201 (p) of the Act [21 U.S. C. § 321 (p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S. C.§ 355(a)]. 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.
 
Furthermore, your products--- Phybiosis Aromune, Kinarome Oregano Oil, and Kinarome PMS & Menopause Synergy---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 layman can use these drugs safely for their intended uses. Thus, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
 
The above violations are not intended to be an all-inclusive list. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
 
In addition, if you market products as dietary supplements, you will need to comply with 21 CFR Part 111 Current Good Manufacturing Practices (CGMPs) regulations for dietary supplements. Please note that the therapeutic claims referenced above in this letter are drug claims, not suitable claims for dietary supplements.
 
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
Blake Bevill
Director Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
 
Sincerely,
/S/                                                            
Alonza E. Cruse
District Director
Los Angeles District
 
Cc:
 
California Department of Public Health
Food and Drug Branch
Ingeborg Small, Branch Chief
1500 Capitol Avenue, MS-7602
P.O. box 997435
Sacramento, CA 95899-7435