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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dragon Herbs 8/15/12

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax  (949) 608-4415 

 

 
WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
August 15, 2012
W/L 35-12
Ron Teeguarden
Dragon Herbs
315 Wilshire Blvd.
Santa Monica, CA 90401
 
Dear Mr. Teeguarden:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.dragonherbs.com in July 2012 and your Dragon Herbs 2nd Edition Catalog and has determined that your products, “CardioPro 2000,” “Cordyceps,” “Duanwood Reishi,” “Gynostemma,” “Ginseng and Astragalus Combination,” “Dang Gui and Gelatin,” “Sweet Relief,” “Remove Stagnation,” “Bupleurum and Dragon Bone,” “Amolo Tea,” “Activated Minor Bupleurum,” “Standardized Scute,” “Salacia,” “Shou Wu Formulations,” “Ant Essence Capsules,” “Ten Complete Supertonic,” “Super Adaptogen,” “Endocrine Health,” “Supreme Protector,” and “Super Pill” 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)(B)]. The therapeutic claims on your website 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 FDA’s regulations through links on FDA’s home page at http://www.fda.gov. 
 
Examples of some of the claims observed on your website on the following product pages include:  
                          
  • “Activated Minor Bupleurum”

“[H]as been demonstrated conclusively to have excellent anti-viral functions in humans with no side effects.”

  • “Standardized Scute”

“Researchers in Scotland report that Baicalin, an extract of the Chinese herb Scutelleria Baicalensis (Huang Qin) [which is a primary constituent of Scute], restores the effectiveness of traditional antibiotics in countering a deadly type of antibiotic-resistant bacterial infection known as MRSA.”

“[T]he antibiotics ampicillin, amoxicillin, benzylpenicillin, methicillin and cefotoxamine can be used effectively to treat MRSA, when combined with Baicalin.”

“Scute has a long history of use in Traditional Oriental Medicine herbal formulas for clearing infections.”

“The Chinese herb Huang Qin has been used in traditional Chinese medicine to treat a wide range of infectious diseases. In this study we have examined the antibacterial action of baicalin, a flavone isolated form the herb. … From the study it was concluded that baicalin has the potential to restore the effectiveness of beta-lactam antibiotics against MRSA….”

  •  “Salacia”

“[H]as been used extensively in Ayurvedic medicine to regulate sugar imbalance…”

“Salacia helps normalize blood sugar and insulin levels…”

“The result is … lower blood glucose and insulin levels

“Traditional Function: Regulate sugar balance”

“Who can use it? Those who desire to regulate blood sugar balance.”

In addition, FDA picked up your Ron Teeguarden’s 2nd Edition Catalog, which is also found on your www.dragonherbs.com website, and other promotional materials for your products at the 2012 Natural Products Expo West trade show that was held on March 8-11, 2012 at the Anaheim Convention Center.
 
Examples of some of the claims observed in your Dragon Herbs 2nd Edition Catalog, which the FDA reviewed in print and online, include the following:
 
  • “CardioPro 2000,” p.29.

“[C]an help lower LDL (‘bad cholesterol’)”

  • “Cordyceps,” p.31
o   “Researchers in Japan and China have isolated a number of polysaccharides in Cordyceps …. and at least one, CO-1, has been shown to have strong anti-tumor activity.”
o   “Cordyceps has been shown to help regulate blood pressure…”
  • “Duanwood Reishi,” p.32
o   “Chemical constituents [of Reishi] known as polysaccharides play an important role in attacking cancerous cells.”
o   “It helps lower LDL (the “bad” cholesterol)”
o   “It has been found to prevent and treat…angina and shortness of breath associated with coronary artery disease.”
o   “[I]t is commonly prescribed by MD’s in Japan for chronic bronchitis…hyperlipidemia…disorders associated with senility.”
  • “Gynostemma,” p.33

“It [Gymnostemma] is an … anti-inflammatory … agent. It also has been found to be anti-ulcer, … anti-hyperlipidemic, cholesterol regulating, anti-obesity…and anti-arthritic.” 

  • “Ginseng and Astragalus Combination,” p.35

“[H]elps to restore immune function in those who have…developed chronic disease.”

  • “Dang Gui and Gelatin,” p.37

“The formula …  prevents bleeding. It is called a ‘hemostatic.’ It breaks up blockages of blood ….”

“The formula can be used by women prone to miscarriage and habitual abortion.”

  • “Sweet Relief,” p.39

“Helps regulate sugar balance by reducing the impact of sugar consumed in the diet. … Who can use this formula – Those who experience a sugar imbalance.”

  • “Remove Stagnation,” p.39

“Helps eliminate blockages and stagnation, especially in the abdomen and legs. … Who can use this formula – People with poor blood circulation in the abdomen and legs.”

  • “Bupleurum and Dragon Bone,” p.43

“[W]idely used in the withdrawal from the addiction to smoking, drinking and to a large variety of addictive drugs by both lessening the cravings for the drug and by reducing the common withdrawal symptoms.”

  • “Amolo Tea,” p.47

“Recent clinical studies conducted in China and elsewhere have demonstrated that continued administration of Amolo by humans … corrects light hypertension, … and reduces blood sugar levels in diabetic people.”

“In China, it is commonly used to relieve diarrhea… Note: Diarrhea can be the symptom of a serious condition.”

In addition, in your product catalog under the heading “Lifestyle Programs”:
 
  • “HIV,” p.58

“The fact that there is a viral infection, the fact that there is increased risk, the fact that the body is in a constant state of attrition, the fact that the HIV-positive individual is taking potent chemical drugs, the fact that life is already innately stressful, it is imperative that the immuno-compromised individual realize that it is not enough to eliminate the virus and other microbes if health is to be restored. Powerful immune-boosting formulas should be included in the program.”

The “powerful immune-boosting formulas” you recommend under the “HIV Lifestyle Program” include: “Shou Wu Formulations,” “Ant Essence Capsules,” “Ginseng and Astragalus [Combination],” “Ten Complete Supertonic,” “Super Adaptogen,” “Endocrine Health,” “Supreme Protector,” and “Super Pill.”
 
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 marketed in the U.S. 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 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 purpose. Thus, your products are misbranded within the meaning of 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 section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen days, please explain the reason for the delay and state the date by which the corrections will be completed.
 
Your response should be sent to:
 
Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
If you have any questions about the content of this letter, please contact Mei-Chen (Jessica) Mu, Compliance Officer, at 949-608-4477.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:       Ingeborg Small
            Branch Chief
            Food and Drug Branch
            California Department of Public Health
            1500 Capitol Avenue - MS 7602
            P.O. Box 997413
            Sacramento, California 95899-7435