Inspections, Compliance, Enforcement, and Criminal Investigations

Dixie Health Inc 8/30/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Atlanta District Office
60 8th St., NE
Atlanta, GA 30309 

 

August 30, 2013
 
 
 
VIA UPS OVERNIGHT DELIVERY
 
 
Ole C. Krarup, President/CEO
Dixie Health, Inc.
2161 New Market Parkway
Suite 222
Marietta, GA 30067-8768
 
WARNING LETTER
(13-ATL-22)
 
Dear Mr. Krarup,
 
This is to advise you that the Food and Drug Administration reviewed your websites at the Internet addresses www.dixiehealth.net and www.tidesoflife.com in July 2013, and the promotional materials distributed with your products, and has determined that you solicit and/or take orders there for the products you market as dietary supplements, Rx Erect, Vaso-Prophin Rx, Dermal K, and High-Q 501, as well as for the topical products, Beta Yam 900, Dermal E, Dermal K, Vasoderm, Dermal DHEA, Dermal-XL, which the websites and promotional materials promote for conditions that cause the products to be 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)].  Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.
 
The following products, which you market as dietary supplements, are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites and promotional materials for these products establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
 
Dermal-K Pills:
 
  • “Relief from varicose veins”
  • “Taking Dermal KT each day will help to alleviate the discomfort of tired, aching swollen legs. Dermal KT is the safe, natural and effective alternative to costly and invasive leg vein procedures that only a physician can perform.”
  • “Using the Dermal KT phytotherapy system will … treat the unsightly, uncomfortable condition of varicose veins.” 
 Rx Erect:
  • “Rx-Erect provides long term benefits to those suffering from any type of sexual dysfunction”
  • “Horny Goat Weed [an ingredient in the product] lowers blood pressure …
o    Properties include: [A]nti-asthmatic, anti-viral, anti-bacterial, anti-inflammatory …”
 
Vaso-Prophin Rx:
  • “An over-the counter neutraceutical caplet to aid in the treatment of Erectile Dysfunction.”
High-Q 501:
  • “This unique natural formula contains:
o   Wild Yam Extract- An anti-inflammatory, anti-spasmodic, blood purifier and diaphoretic.”
 
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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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, these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for their intended uses. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
TOPICAL PRODUCTS
 
In addition, your websites promote your topical products for conditions that cause the products  to be drugs under section 201(g)(1)(B) and/or (C) of the Act [21 U.S.C. § 321(g)(1)(B) and/or (C)]. The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are promoted to affect the structure or function of the body. 
 
Examples of some of the claims that provide evidence that your topical products are intended for use as drugs include:
  
Beta Yam-900:
  • “PMS & Menopause Relief & Osteoporosis Protection”
  • “Contains BOTH 900 mg. USP progesterone as well as 1995 mg. Dermasterone”
  • “SOME OF PROGESTERONE’S MANY ROLES:
o   Natural Anti-depressant …
o   Normalizes Blood Sugar Levels …
o   Alleviates Hormone Related Migraine Headaches …
o   Normalizes Blood Clotting …
o   Helps Prevent Breast Cancer
o   Helps Prevent Endometrial Cancer …”
 
Vasoderm:
  • “Vasoderm is a topically applied male enhancement gel that dramatically increases penile blood flow, which increases strength and duration of erections by increasing Nitric Oxide.”
  • “Nitric Oxide passes directly into adjacent smooth muscles, such as those found in the penis, causing them to relax… reducing blood pressure and increasing blood supply to the penis. Nitric Oxide acts as an essential chemical trigger producing erections. Viagra ® also increases the level of Nitric Oxide but can have side effects.”
 Dermal C:
  •  “Dermal- C is the most advanced Vitamin C topical … protection against UV photo aging. 
Dermal E: 
  • “This cream will aid psoriasis and eczema treatment, and in scar and acne removal”
Dermal K:
  • “Heal Spider Veins, Bruises, Burns and Scars, Eczema and Psoriasis”
  • “See spider veins disappear … Dermal-K is also great for healing bruised, sunburned or damaged skin and fading scars.”
  • “Helps with healing of bruises, sunburns or damaged skin and fading scars. It can also aid in the treatment of exzema and psoriasis.”
  • “It is most widely known for its ability to heal spider veins and make them disappear.”
Dermal XL:
  • “Contains … testosterone precursors, this … transactive energizing lubricant provides long acting benefits previously obtainable only through prescription drugs.”
  • “It also contains … Boron, which is so important for the production … testosterone in the body, as well as D.H.E.A., which binds to the same receptor sites as Testosterone.”
  • “[C]ontains the Chinese herb Schizandra Chinesis which … has the following actions: antibacterial, antidepressant, antifatigue, aphrodisiac, improves endurance, mental performance, physical performance, urogenital tonic and uterine stimulant…helpful for night sweats. Herbalists currently use another herb in this formula, Smilax, for frigidity, hormone balance and boosting energy.”
Miracle Thigh Cream:
  • “Clematis Extract [an ingredient in the product]-Acts as a decongestant and has a dynamic effect on blood. Stimulates circulation and reduces water retention.”
  • “Bladderwrack Extract [an ingredient in the product]- High in iodine that helps to act as a natural diuretic, stimulates the thyroid gland, removes accumulation of fat, decongestant, stimulant”
  • “Horsetail Extract [an ingredient in the product]-  … produces new elastin and collagen fibers …”
Estrogyn Gel:
  • “Calms hot flashes and night sweats and restores normal sleep patterns for most women.”
  • “Has a stabilizing effect on the entire endocrine system.”
  • “Exhibits dh-testosterone blocking qualities which reduce masculinization such as facial hair growth.”
Breastique:
  • “Breastique will safely and effectively help enhance women’s breast size by increasing the amount of cells in the mammary glands.”
  • “Breastique is an improvement on current breast enhancement products and procedures…using herbs that are known to balance hormones, promote breast size and firmness, Breastique is a natural alternative to harmful drugs and surgery. From 1 to 3 cup size increases have been reported over 9 months usage! Many also report a decrease in PMS, bloating, nervous tension and other hormone related problems.”
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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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.
 
The above violations are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA.   You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
 
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at Resident Post, 4600 Goer Drive, Charleston, SC 29406. If you have questions, please contact Mrs. King at (843)746-2990 or write her at the noted address. 
 
 
Sincerely,
/S/ 
John R. Gridley
District Director
Atlanta District Office

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