Inspections, Compliance, Enforcement, and Criminal Investigations

Esteem Products LTD 12/7/16

 

  

Black HHS-Blue FDA Logo

 

 

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

 

December 7, 2016
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 17-05
 
John W. Sheaffer, CEO
Esteem Products Ltd
P.O. Box 1678
Duvall, Washington 98109
 
WARNING LETTER
 
Dear Mr. Sheaffer:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.esteemproducts.com in December 2016 and has determined that you take orders there for the products Cardio Life, Total Man, Total Woman, Senior Total Man, Senior Total Woman, and Total Teen. The claims on your website establish that the products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Cardio Life:
  • “Cardio Life contains nutrients known to … lower cholesterol …”
  • “It is not a quick fix, but rather an alternative, in many ways, to heavy prescription drug usage.”
  • “GTF CHROMIUM (Chromate) … lowering cholesterol levels.”
  • “HAWTHORNE (berries) … Helps lower blood pressure …”
  • “L-CARNITINE … reduces risk of heart disease by preventing fatty build-up.”
  • “L-PROLINE … Heals cartilage …”
  • “NIACIN ... Lowers cholesterol …”
  • “COBALAMIN ... prevents nerve damage.”
  • “OMEGA 3 (fish oil) … Lowers levels of cholesterol and triglycerides.”
  • “SIBERIAN GINSENG (50X … Shown to aid in resisting hypertension and angina.”
  • “GARLIC … Helps lower blood pressure and cholesterol levels.”
  • “OAT BRAN … Helps … reduce cholesterol levels.”
  • “BETA SITOSTEROL … Help to lower cholesterol.”
  • “STIGMASTEROL/CAMPESTEROL … Help to lower cholesterol.”
  • “RUSCUS ACULEATUS (butcher's broom) … Treats circulatory disorders.”
Total Man:
  • “FENUGREEK … lowers cholesterol …”
  • “BEE POLLEN … Effective for combating … depression, cancer and colon disorders.”
  • “GARLIC … a natural antibiotic.”
  • “SARSAPARILLA … It's used for impotence …”
  • “PLANTAIN LEAF … helpful with prostatitis …”
  • “SIBERIAN GINSENG … Used for impotence …”
  • “ECHINACEA … Used for … infections and has antibiotic, antiviral, and anti-inflammatory properties.”
Total Woman:
  • “[P]romotes … cholesterol …”
  • “DANDELION ROOT … Helps relieve cramps … and breast tumors.  May aid in the prevention of breast cancer ...”
  • “GARLIC … A natural antibiotic … Protects from yeast infections …”   
  • “ECHINACEA … Used for infections.  Has antibiotic, antiviral, and anti-inflammatory properties.”
Senior Total Man:
  • “Ginkgo Biloba … Improves … depression …”
  • “Pygium Africanum … Effective in reducing prostate enlargement.”
  • “Garlic Bulb … A natural antibiotic.”
  • “Gotu Kola Decreases … depression …”
  • “Bee Pollen Combats … depression, cancer and colon disorders.”
  • “Fenugreek seed … Helps lower cholesterol, good for lung disorders, asthma …”
  • “MSM (Methyl Sulfone) … Heals injuries, relieves pain/inflammation …”
  • “Parsley root … Good for prostate disorders … halitosis and high blood pressure ...”
  • “Ginger root … arthritis/muscle pain ...”
  • “Devil’s Claw root … Relieves pain and reduces inflammation.” 
Senior Total Woman:
  • “MSM (Methyl Sulfone) … Heals injuries, relieves pain/inflammation …”
  • “Ginkgo Biloba … Improves … depression … ”
  • “Oat Straw … Antidepressant …”
  • “Black Cohosh (4x1) pwd ext Relieves … circulatory disorders, pain and arthritis …”
  • “Garlic Bulb … A natural antibiotic.”
  • “Bee Pollen Combats … depression, cancer and colon disorders.” 
  • “Muira Puama (4x1) pwd ext Beneficial in treating impotence, nervous system disorders and depression.”
  • “White Willow Bark Relieves pain and inflammation from headaches, backaches and joints.”
  • “Cramp Bark Relieves … pain ...”
  • “Meadowsweet Root Reduces inflammation.”
  • “Devil’s Claw Root Relieves pain and reduces inflammation.”
Total Teen:
  • “TOTAL Teen addresses: - ADD/ADHD … depression … Regulates blood sugar levels …”
  • “With Total Teen, look for marked improvement in … attention disorders (ADD, ADHD) …”
  • “FLAX SEED … Helps … children with learning disabilities such as ADD, ADHD and behavior problems.”
  • “ALFALFA LEAF … Good for anemia, ulcers …”
  • “ST. JOHN’S WORT … Has been found to relieve mild to moderate depression …” 
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. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s).  “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products Cardio Life, Total Man, Senior Total Man, Senior Total Woman, and Total Teen are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Cardio Life, Total Man, Senior Total Man, Senior Total Woman, and Total Teen fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
This letter is not intended to be an all-inclusive list of the 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 ensure that your firm complies with the Act and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations and implement lasting corrective action of these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations, or other similar violations, from occurring again. You should include documentation of corrective actions you have taken to date. If your firm’s planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
 
Your reply 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 17-05 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Patricia Pinkerton by telephone at 425-302-0428. 
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
cc: 
Amy M. Brailsford, President
Esteem Products Ltd
P.O. Box 1678
Duvall, Washington 98019
 
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
 
Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue NW
Washington, D.C. 20580
 

 

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