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

 
 

 

August 15, 2017
 
2017-DAL-WL-26
 
WARNING LETTER
 
UPS Overnight
 
Lonnie G. Redd, Owner
Years to Your Health
503 E. 2nd St.
Irving, TX 75060
 
Dear Ms. Redd,
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your company website at the internet address www.yearstoyourhealth.com in January and April of 2017 and has determined that you take orders there for the products discussed below. In addition, we have reviewed your product labels for your Arthritis, Tumor, Eyes, and Bone Rejuvenation products. The claims for products on your company website, and your Arthritis and Tumor product labels, establish that the listed 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. Additionally, we have determined that your Bone Rejuvenation product is misbranded under section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under 21 CFR part 101, and that, even if your Arthritis, Tumor, and Eyes products were not drugs under section 201(g)(1)(B) of the Act, they would be misbranded under section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under 21 CFR part 101.
 
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
 
Unapproved New and Misbranded Drugs
 
Examples of claims on your product labels that provide evidence that your products are intended for use as drugs include:
 
Arthritis
Tumor
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Infection
Food Poisoning / Poultice
Ulcer / Wound
Asthma/Hay Fever
Energy Pick-Up
Blood Pressure
Pain Relief
Cold & Flu
Chest & Lungs
Memory & Mental Alertness
Eyes
Diabetes & Pancreas
Sinus & Hay Fever
Arthritis
Drug Withdrawal
Tumor
Anemia & Iron
Calcium & Minerals
Parasites
Hypoglycemia
Tissue & Bone Rejuvenation
Colitis
Congestion
Kidney Stones
Seizure Relief
Varicose Veins/Hemorrhoids
Lymphatic System
Gout
Stop Smoking Aid
Flu Guard Blend
Healthy Cholesterol
Herpes/Virus Support
Adrenal/Thyroid
Eczema/Great Skin
Inflammation
Anti-Fungal
Bronchitis Blend Tea
Candida/Yeast Infection Tea
Cataract Tea
Cold Care / Congest Ease Tea
Fat Flush / LDL Flush Tea
Feminini Tea / Female Tea
Fight Back Flu Tea
Gluco Tea
Gout Tea
Headache Tea
Hemorrhoid Tea
Kidney / Bladder Tea / K/B Tea
Memory & Emotional Uplift Tea
Mother’s Friend Tea
Root Beer Tea/Arthritis Tea
Smoking Blend Tea
Sore Throat Tea / STH Tea
Tumor Tea
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 a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate 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.
 
Furthermore, your Ulcer / Wound, Energy Pick-Up, Chest & Lung, Eyes, Asthma/Hay Fever, Memory & Mental Alertness , Diabetes & Pancreas, Seizure Relief, Gluco Tea, Bronchitis Blend Tea, and Memory & Emotional Uplift Tea products 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 these products safely for their intended purposes.  Accordingly, your Ulcer / Wound, Energy Pick-Up, Chest & Lung, Eyes, Asthma/Hay Fever, Memory & Mental Alertness , Diabetes & Pancreas, Seizure Relief, Gluco Tea, Bronchitis Blend Tea, and Memory & Emotional Uplift Tea products fail to bear adequate directions for their intended use and, therefore,  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)].
 
Misbranded Dietary Supplements
 
Your Bone Rejuvenation product is misbranded under section 403 of the Act [21 U.S.C. § 343] in that the label does not comply with the labeling requirements in 21 CFR 101. Additionally, even if your Years to Your Health website, www.yearstoyourhealth.com, did not contain claims that cause your Eyes, Arthritis, and Tumor products to be unapproved new and misbranded drugs, these products would still be misbranded foods under section 403 of the Act [21 U.S.C. § 343] in that the labels for these products do not comply with the labeling requirements in 21 CFR 101, as follows:
 
1.    Your Arthritis, Bone Rejuvenation, and Tumor products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. For example:
2.    Your Eyes, Arthritis, Tumor, and Bone Rejuvenation products are misbranded within the meaning of sections 403(q)(1)(B) [21 U.S.C. §343(q)(1)(B)] and 403(q)(5)(F) [21 U.S.C. §343 (q)(5)(F)] because the label fails to declare the number of servings per container, as required by 21 CFR 101.36(b)(1)(ii).
 
3.    Your Eyes, Arthritis, Tumor, and Bone Rejuvenation products are misbranded within the meaning of sections 403(s)(2)(A)(ii)(I) [21 U.S.C. § 343 (s)(2)(A)(ii)(I)] and 403(q)(5)(F) [21 U.S.C. §343 (q)(5)(F)] of the Act in that the labels fail to include the quantitative amount by weight per serving size of all the dietary ingredients, as required by 21 CFR 101.36.
 
4.    Your Eyes, Arthritis, Tumor, and Bone Rejuvenation products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] because they fail to bear nutrition information (“Supplements Facts” label), as required by 21 CFR 101.36.
 
5.    Your Tumor product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Specifically, the ingredient greasewood does not identify the part of the plant the ingredient is derived from.
 
The violations cited in this letter are not intended to be an all-inclusive list 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 that all products marketed by your firm comply with the Act and its implementing regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction. 
 
We offer the following comments:
 
1.    The statement of identity of “Botanical Supplement” regarding your Eyes, Arthritis, Tumor, and Bone Rejuvenation products is not presented in bold type on the principal display panel and in a size reasonably related to the most prominent printed matter on such panel in accordance with 21 CFR 101.3(d).
 
2.    Your Eyes, Arthritis, Tumor, and Bone Rejuvenation product labels must position the net quantity of contents within the bottom 30 percent of the area of the principal display panel in accordance with 21 CFR 101.7. 
 
3.    You did not permit entry or inspection when an officer presented appropriate credentials and a written notice of inspection on January 23, 2017. You are reminded that failure to comply with the requirements of Section 704 [21 U.S.C § 374] of the Act is a prohibited act under Section 301(f) of the Act  [21 U.S.C. § 331(f)].
 
(b)(3)(A)
 
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 violations noted above. Your response should 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 within fifteen business days, please explain the reason for your delay and the date by which you will make the correction. 
 
Your written response should be sent to Chad J. Whitwell, 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 Mr. Whitwell at 214-253-5328.
 
Sincerely,
/S/                                                           
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
 
CC:     
Mr. Greg Wilburn
Inspection Unit Manager
Food and Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756

This page was posted on April 30, 2019.

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