Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579558.htm
Timestamp: 2019-04-24 01:54:11+00:00

Document:
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.
“The herbs in this blend have been carefully selected for their effectiveness in healing…the Adrenals and the Thyroid.
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.
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)].
Your Arthritis and Tumor product labels declare the ingredient Greasewood as opposed to the Latin binomial or the standardized common name “white sage” as noted in the reference Herbs of Commerce.
Your Bone Rejuvenation product label declares the ingredient Gravel Root as opposed to the Latin binomial or the standardized common name “trailing arbutus” as noted in the reference Herbs of Commerce.
Your Tumor product label declares the ingredient Taheebo as opposed to the Latin binomial or the standardized common name “pau d’arco” as noted in the Herbs of Commerce; also, this product does not declare the Latin binomial or the standardized common name for Blue Violet.
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.
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.
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)].
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.

References: § 321
 § 343
 § 343
 § 321
 § 352
 § 331
 §343
 §343
 § 343
 §343
 § 343
 § 343
 § 374
 § 331