Inspections, Compliance, Enforcement, and Criminal Investigations

Years to Your Health, Inc. 8/15/17

 

  

Black HHS-Blue FDA Logo

 

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
  • “Arthritis” 
Tumor
  • “Tumor” 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Infection
  • “A healthy lymphatic system plays a major role in helping the body defend itself against various infections. Black Walnut Hulls, Cayenne, Echinacea Angustifolia Root, Goldenseal Root, and Nettle Leaf assist in fighting infection...” 
Food Poisoning / Poultice
  • “Food Poisoning”
  • “Taken internally, this blend of herbs will absorb toxins from putrefied foods, treat bacteria in the stomach…Many skin irritations such as boils…abscesses, insect bites and wounds can be treated with a poultice of [ingredients]. In addition, applying the remedy externally to the affected area can help enlarged glands, burns, arthritis and joint pain.” 
Ulcer / Wound
  • “Cayenne, Comfrey Root, Echinacea Angustifolia Root, Goldenseal Root and Myrrh Gum relieve and heal internal and external ulcers and wounds.” 
Asthma/Hay Fever
  • “Asthma”
  • “By using a blend of Black Cohosh Root, Blessed Thistle Herb, Cayenne, Catnip Herb, Comfrey Root, Mullein Leaf, Pleurisy Root and Skullcap Herb, relief from seasonal allergies and upper respiratory symptoms is provided.”
Energy Pick-Up
  • “Gotu Kola is valued for its curative properties in the treatment of…depression.” 
Blood Pressure
  • “Blood Pressure”
  • “For regulating blood pressure…” 
Pain Relief
  • “Ingredients that include Blessed Thistle Herb, Blue Violet Leaf, Scullcap Herb, Valerian Root, Blue Vervain Herb, Wild Lettuce Leaf, Hops Flowers, Passion Flower Leaf and White Willow Bark…ease various cases of pain.”
Cold & Flu
  • “Bayberry Root Bark, Cayenne, Cloves, Comfrey Root, Fenugreek Seed, Echinacea Angustifolia Root, Ginger Root, Goldenseal Root, Thyme Leaf and White Willow Bark are used to relieve fevers, infections, mucus build-up, and respiratory complaints.”
Chest & Lungs
  • “A blend of Comfrey Root, Fenugreek Seed, Marshmallow Root, Mullein Leaf, Slippery Elm Bark, Thyme Leaf and Yerba Santa Leaf treats respiratory symptoms. This formula is good for bronchitis, pneumonia, asthma and emphysema.”
Memory & Mental Alertness
  • “This formula also provides relief for…depression.”
Eyes
  • “A mixture of Bayberry Root Bark, Cayenne, Chamomile Flowers, Eyebright Herb, Fennel Seed, Ginkgo Biloba Leaf, Goldenseal Root, Greasewood, Red Raspberry Leaf and Blue Vervain Herb heals symptoms associated with cataracts, conjunctivitis and lesions...” 
Diabetes & Pancreas
  • “Diabetes”
  • “The body needs insulin to regulate blood sugar. If the pancreas produces too much or too little insulin, problems such as diabetes occur. By using Blueberry Leaf, Cayenne, Dandelion Root, Ginger Root, Goldenseal Root, Juniper Berry, Licorice Root, Myrrh Gum, Red Raspberry Leaf and Saw Palmetto Berry, the pancreas is assisted in reverting to its natural function.”
Sinus & Hay Fever
  • “Hay Fever”
  • “Bee Pollen, Blue Cohosh Root, Cayenne, Goldenseal Root, Hyssop, Mullein Leaf and Saw Palmetto Berry are decongestant and furnish relief from allergies with their natural antihistamine qualities.” 
Arthritis
  • “To reduce or eliminate rheumatic and arthritic conditions, the body needs to be cleansed from calcium deposits that are built up in the blood stream. Using Alfalfa Leaf, Buckthorn Bark, Comfrey Root, Devil's Claw Root, Greasewood, Licorice Root, Sassafras Root Bark, Slippery Elm Bark, Wild Yam Root, Yarrow Flowers and Yucca Root can reduce swelling and inflammation. This formula also removes toxins and bacteria from the body.” 
Drug Withdrawal
  • “A formula of Black Cohosh Root, Cayenne, Ginger Root, Goldenseal Root, Greasewood, Hops Flowers, Licorice Root, Sage Leaf, Scullcap Herb and Valerian Root can detoxify the body and aid in withdrawal from drug or substance dependence.”
Tumor
  •  “Parsley Leaf, Beet Root, Black Walnut Hulls, Blue Violet Leaf, Echinacea Angustifolia Root, Greasewood, Plantain Leaf, Pau d'Arco, Red Clover Leaf, Red Raspberry Leaf, Slippery Elm Bark and Yellow Dock Root are purported to reduce tumor growth.” 
Anemia & Iron
  • “[I]ron deficiency…”
Calcium & Minerals
  • “These are important to the healing process for broken bones…” 
Parasites
  • “The combination of Cloves, Black Walnut Hulls, Greasewood, Motherwort Herb, Pumpkin Seed, White Oak Bark, Wood Betony Herb and Wormwood can help alleviate internal parasites” 
Hypoglycemia
  • “Hypoglycemia”
  • “Hypoglycemia is the result of imbalanced functions in the adrenal glands and the pancreas. Cayenne, Cedar berry, Dandelion Root, Eleuthero Root, Ginger Root, Gotu Kola, Hawthorn berry, Juniper Berry, Lobelia, Mullein leaf, and Sarsaparilla Root assist the body in stabilizing blood sugar levels. While blood sugar problems can be helped with this formula, it is also important to concentrate on a nutritious diet to ensure a complete recovery…”
Tissue & Bone Rejuvenation
  • “Black Walnut Hulls, Comfrey Root, Gravel Root, Lobelia, Marshmallow Root, Mullein Leaf, Scullcap Herb, White Oak Bark and Wormwood also aid in healing tendons and torn ligaments.”
Colitis
  • “Colitis”
  • “Making dietary changes and using a mixture of Comfrey Root, Ginger Root, Lobelia, Marshmallow Root, Slippery Elm Bark and Wild Yam Root can reduce inflammation and pain from colitis.”
Congestion
  • “Congestion”
  • “A formula of Pleurisy Root, Hyssop Leaf, Blue Vervain Herb, Yerba Santa Leaf, Fenugreek Seed, Ginger Root, Peppermint Leaf, Eleuthero Root, Red Raspberry Leaf, Horehound, Horseradish Root and Chamomile Flowers soothes the mucous membranes and removes mucus build-up due to upper and lower respiratory conditions.” 
Kidney Stones
  • “Kidney Stones”
  • “The experience of kidney stones can be quite painful. Agrimony, Hydrangea Root, Marshmallow Root, Stone Root, Gravel Root, Lobelia and Ginger Root can dissolve and remove accumulations of minerals in the kidneys and urinary tract.” 
Seizure Relief
  • “Seizure”
  • “Mistletoe Leaf, Lobelia, Black Walnut Hulls, Blue Vervain Herb, Cayenne, Scullcap Herb, Eleuthero Root, Wild Lettuce Leaf, Black Cohosh Root and Hyssop Leaf have been found to aid those that are plagued with seizures.” 
Varicose Veins/Hemorrhoids
  • “Varicose Veins/Hemorrhoids”
  • “Varicose veins are enlarged, swollen veins (usually in the legs) that are primarily due to poor venous circulation. This also includes hemorrhoids. Bayberry Root Bark, Butcher's Broom, Cayenne, Goldenseal Root, Rosehips, White Oak Bark and Witch Hazel Leaf & Bark improve circulation and provide an astringent effect that improves these conditions.”
Lymphatic System
  • “By stimulating the removal of metabolic waste from the circulatory fluids, a combination of Black Walnut Hulls, Echincea Angustifolia Root, Goldenseal Root, Myrrh Gum, Pau d'Arco, Licorice Root, Comfrey Root and Rosehips helps relieve swollen…lymph glands.”
Gout
  • “Gout”
  • “Birch Bark, Burdock Root, Hyssop Leaf, Juniper Berry, Hydrangea Root and Devil's Claw Root can reduce swelling and calcification around joints by clearing toxicity. This formula is a valuable aid in dealing with gout.”
Stop Smoking Aid
  • “Stop Smoking Aid”
  • “Lobelia, Catnip, Horehound, Marshmallow Root, Mullein Leaf, Passion Flower Herb and Slippery Elm Bark are historically considered to be aids in reducing the desire for nicotine…”
Flu Guard Blend
  • “Flu Guard Blend”
  • “No need to be scared of getting the Flu with this formula containing Boneset Leaf, Catnip Leaf, Chamomile Flowers, Echinacea Purpurea Root, Garlic, Ginger Root, Goldenseal Root, Grindelia Herb, Slippery Elm Bark, Blue Vervain Leaf, Yarrow Flowers and Yerba Santa Leaf. It is designed to ward off viruses, keeping your immune system healthy enough to protect itself. Works best in combination with the Fight Back Flu Tea, they will speed recovery of the Flu virus and Flu-like symptoms.” 
Healthy Cholesterol
  • “Healthy Cholesterol”
  • “This formula containing Artichoke Leaf, Cayenne, Chickweed Leaf, Eleuthero Root, Fenugreek Seeds, Ginger Root, Gymnema Leaf, Hawthorn Berry, Shiitake Mushrooms, Parsley Leaf and Suma Root is an herbal solution to having healthy cholesterol levels.”
Herpes/Virus Support
  • “Herpes/Virus”
  • “This blend, comprised of Ashwagandha Root, Burdock Root, Fennel Seeds, Fenugreek Seeds, Hydrangea Root and Licorice Root, is designed to…reduce inflammation, and therefore ease the symptoms of Herpes viruses. This formula accomplishes this through its antimicrobial properties…”
Adrenal/Thyroid
  • “The herbs in this blend have been carefully selected for their effectiveness in healing…the Adrenals and the Thyroid.
  • “[A]bility to handle pain…” 
Eczema/Great Skin
  • “Eczema” 
Inflammation
  • “Inflammation”
  • “This 4 herb mixture will help reduce general inflammation in the body from the usual arthritis to the digestive tract…” 
Anti-Fungal
  • “Anti-Fungal”
  • “Olive Leaf, Garlic Bulb, Neem Leaf, Taheebo Bark and Oregano Leaf are all great herbs to help treat any internal fungal infections, like candida, by boosting the body's defences against funguses.”
Bronchitis Blend Tea
  • “Bronchitis”
  • “This tea is extremely effective for chronic lung complaints.” 
Candida/Yeast Infection Tea
  • “Candida/Yeast Infection Tea”
  • “Candida yeast sufferers take heart. This herbal tea has purifying, immune boosting, astringent, anti-inflammatory, pain soothing and fungus fighting properties...” 
Cataract Tea
  • “Cataract Tea”
  • “Cataracts are white, cloudy blemishes on the normally transparent lens of the eye which progressivley blur the vision. The herbs in this tea promote circulation and help to protect the small capilary vessels of the eye. Its nutritive, anti-oxidant and anti-inflammatory properties help to alleviate toxic and free-radical elements from damaging the tissues of the eyes...” 
Cold Care / Congest Ease Tea
  • “Cold Care / Congest Ease Tea”
  • “Sinus sufferers will benefit from this tea as well as those with a miserable, aching cold. Good for excess mucus…” 
Fat Flush / LDL Flush Tea
  • “LDL”
  • “This tea is a blend of seventeen herbs specifically formulated to help the body flush away fat while at the same time providing nutrients and vitality, boosting the metabolism, detoxifying and helping to control cholesterol, especially LDL (Low Density Lipid), and also helping to balance blood sugar…” 
Feminini Tea / Female Tea
  • “Every woman's answer to painful periods...” 
Fight Back Flu Tea
  • “Fight Back Flu Tea”
  • “This tea provides an effective means of fighting off and relieving the symptoms of flu. It combines herbs which are anti-biotic, anti-inflammatory and fever reducing, pain relieving, decongestant and expectorant, and antispasmodic or cough supressing.” 
Gluco Tea
  • “This blend of herbs for diabetes is helpful in balancing blood sugar levels and is safe to use two hours apart from other diabetes medications.” 
Gout Tea
  • “Gout Tea”
  • “This blend of twelve anti-inflammatory, diuretic and pain relieving herbs helps to rid the body of harmful deposits and calcification around joints and can also help reduce the swelling and pain associated with such deposits...” 
Headache Tea
  • “Headache Tea”
  • “It is helpful for migraine and relaxes muscles associated with tension  headaches…” 
Hemorrhoid Tea
  • “Hemorrhoid Tea”
  • “This tea blend is specially formulated to help heal the swollen and ruptured vessels that cause hemorrhoids...” 
Kidney / Bladder Tea / K/B Tea
  • “[P]reventing infections…”
Memory & Emotional Uplift Tea
  • “Great for depression…”
Mother’s Friend Tea
  • “[R]elieves pain...”
Root Beer Tea/Arthritis Tea
  • “Arthritis Tea”
  • “This tea is an anti-inflammatory for arthritis...” 
Smoking Blend Tea
  • “[M]any of the herbs…have antimicrobial characteristics.”
Sore Throat Tea / STH Tea
  • “Sore Throat Tea”
  • “You're one cup away from soothing that sore throat. An effective blend of roots and barks goes to work immediately to clear up scratchy, dry and infected throat problems.” 
Tumor Tea
  • “Tumor”
  • “For the reduction of tumor growth...”
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:
  • 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.
 
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
 

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