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WARNING LETTER

Young Health Products MARCS-CMS 525423 —

Recipient:
Recipient Name
Deanna K. Naylor
Young Health Products

4845 Keller Springs Road
Addison, TX 75001
United States

Issuing Office:
Dallas District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations West Division 3
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204

 
 

 

January 24, 2018
 
CMS # 525423
 
WARNING LETTER
 
UPS OVERNIGHT
 
Deanna K. Naylor, Co-Owner
Young Health Products LLC
4845 Keller Springs Road
Addison, Texas 75001
 
Dear Ms. Naylor:     
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.younghealth.com in November 2017 and again in January 2018, and has determined that you take orders there for your Lugol’s Solution 2%, Liquid Vitamin D3, Probimune, Flax Seed & Omega 3-6-9 Fish Oil, Balance Drops, Whey Protein, and Fruit of the Spirit. The claims on your website, including the new customer booklet available through your website (“The Young Health Revolution”), establish that these products are drugs under Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of these products for 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 claims and testimonials that provide evidence your products are intended for use as drugs include:
 
Lugol’s Solution 2%
  • “Helps synthesize thyroid hormones”
  • “Activates hormone receptors”
  • “Can decrease insulin need for diabetic” 
Liquid Vitamin D3
  • “Helps regulate blood pressure”
  • “Relieves body aches & pains by reducing muscle spasms”
Probimune
  • “Reduce GI Inflammation”
  • “Reduce Allergic Responses”
  • “Repair Damaged Intestines”
  • “Balance Blood Pressure” 
Flax Seed & Omega 3-6-9 Fish Oil
  • “… Cod liver oil [an ingredient in your Flax Seed & Omega 3-6-9 Fish Oil] is a great source of vitamins A and D and also has Omega fatty acids like EPA and DHA that can help nourish the body when attacked by conditions like cardiovascular disease, cancer, diabetes, neurological illnesses like Alzheimer’s & autism, arthritis, and asthma.” (“The Young Health Revolution,” page 7)
  • “The Omega 3-6-9 blend is a very anti-inflammatory (a great weapon against aches and pain) …” (“The Young Health Revolution,” page 13)
Balance Drops
  • “[Balance Drops] help the body maintain the acid/base balance in blood and other tissues. If acid levels rise even a little, the body must rob alkaline minerals from the bones (osteoporosis)…” (“The Young Health Revolution,” page 7)
Young Health Whey Protein, Young Health Flax Seed & Omega 3-6-9 Fish Oil, Young Health Balance Drops, and Fruit of the Spirit (ingredients in your Young Health Shake)
  • “Traditional treatment of diabetes, high blood pressure, inflammatory conditions, and other chronic diseases, involves prescription medications…When your cellular foundation is healthier, the entire body is healthier… [Y]ou can take steps to keep your cells in the best condition with the Young Health Shake.” (“The Young Health Revolution,” page 1)
  • “This shake is very anti-inflammatory …” (“The Young Health Revolution,” page 6)
  • “I have struggled with osteoarthritis for years and The Young Health Shake made a big difference in my flexibility, and pain over time as I took the Health Shake.” (“The Young Health Revolution,” page 9, testimonial from Steve)
  • “Since being diagnosed with Type 2 diabetes, my blood sugar’s been high and at age 62, neuropathy began to set in. I began to lose feeling in my feet and it moved up my legs and they say that’s the first sign that Diabetes [sic] is totally out of control. A friend told me about Dr. Young….got me off my prescription, suggested some lifestyle changes and put me on The Young Health Shake and in 6 weeks my blood sugar is back to normal, my neuropathy has all but disappeared, and my vision has improved.” (“The Young Health Revolution,” page 9, testimonial from Bill)
  • “The Young Health Shake is beneficial for people of all health levels. We have also achieved positive results with the following conditions: Arthritis, Asthma, Autoimmune Disorder, Cardiovascular Disease, Chronic Fatigue, Crohn’s Disease, COPD, Depression, Heart Failure, Hypertension, Irritable Bowel Syndrome, Psoriasis, Neuropathy, Fibromyalgia, and Ulcerative Colitis.” (“The Young Health Revolution,” page 13) 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 new drugs 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 Balance Drops, Whey Protein, Flax Seed & Omega 3-6-9 Fish Oil, Fruit of the Spirit, and Lugol’s Solution 2% 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, Balance Drops, Whey Protein, Flax Seed & Omega 3-6-9 Fish Oil, Fruit of the Spirit, and Lugol’s Solution 2%, fail to bear adequate directions for their intended use and, therefore, these 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)].
 
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 ensure your establishment is in compliance with all requirements of federal law, including FDA regulations. 
 
You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction or seizure. 
 
You should notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documents. If you cannot complete all corrective actions before you respond, state the reason for your delay and the time within which you will correct the remaining deficiencies. 
 
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Bumpas at 214-253-5336.
 


 
Sincerely,
/S/                                                           
Edmundo Garcia, Jr.
Program Division Director
District Director
Human & Animal Food Operations, WD3
              
 
CC:     
Jeremy Meyer, Co-Owner
Young Health Products
4845 Keller Springs Road
Addison, Texas 75001
 
Dr. John Young, Medical Director and Co-Owner
Young Health Products
7241 Bryan Dairy Road
Largo, Florida 33777
           
Peter Ristorcelli, Financial Director, Co-Owner
Young Health Products
1212 66th Street North
St. Petersburg, Florida 33710
 
Mr. Greg Wilburn
TX Department State Health Services
Inspection Unit Manager
Food and Drug Inspections Branch
1100 West 49th Street
 Austin, Texas 78756

 

 
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