• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Wellness Resources, Inc. 27-Dec-05

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

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612)758-7132
FAX: (612) 334-4142



December 27, 2005

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 06 – 16

Byron J. Richards
President
Wellness Resources, Inc.
7155 Amundson Avenue
Edina, Minnesota 55439

Dear Mr. Richards:

The Food and Drug Administration (FDA) inspected your firm located at 7155 Amundson Avenue, Edina, Minnesota, on May 18-19 and June 7, 2005. During the inspection our investigator collected labeling for your products, including product labels, literature available to customers on your premises and literature included in product shipments. In addition, we reviewed your website at the Internet address http://www.wellnessresources.com. Our review of the labeling collected during the inspection and provided on your website identified the following violations of the Federal Food, Drug, and Cosmetic Act (the Act):

Dietary Supplements Without Iron Statement:

Your products Blood Builder and Super Mini-Multi Children's MultiVitarnin are misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act [21 U .S.C . 343(a)(1) and 21 U.S.C. 321(n)] because the labels for these products, which contain added iron, fail to bear the following warning statement as required by Title 21, Code of Federal Regulations 101.17(e) [21 CFR 101.17(e)]:

"WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."

Dietary Supplements Without Psyllium Husk Statement:

Your product Fiber Helper™ is misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act [21 U.S.C. 343(a)(1) and 21 U.S.C. 321(n)]. Your labeling for this product, which contains psyllium seed husk, bears a health claim on the association between soluble fiber from psyllium seed husk and reduced risk of coronary heart disease. However, the label for this product fails to bear a label statement, as required by 21 CFR 101.17(f), informing consumers that the appropriate use of such foods requires consumption with adequate amounts of fluids, alerting them of potential consequences of failing to follow usage recommendations, and informing persons with swallowing difficulties to avoid consumption of the product.

Disease Claims:

Under section 201(g) (1) (B) of the Act [21 U.S.C. 321(g) (1) (B) ), articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. Claims that appear on your product labels, in product literature that you distribute to customers, and on your website at http://www.wellnessresources.com promote some of your products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)) . The claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Examples of disease claims observed in your products' labeling, including your website, product labels, and product literature include:

Black Currant Oil

From your website:

  • "Helps reduce inflammation and pain."

  • "High potency anti-inflammatory oil, may help reduce pain of any type, especially ongoing/chronic pain"

  •  "Proven in several clinical trials to reduce the pain and symptoms of rheumatoid arthritis"

From the label:

  • "It is a safe and effective natural anti-inflammatory. It has been proven to reduce joint pain . . ."

 

From literature:

  • "Helps regulate inflammation and reduce arthritic pain. Also helps lower blood pressure.”

  • "Proven in clinical trails to reduce the pain of rheumatoid arthritis."

 

CALCIUM-AEP

From your website:

  • "Excellent product for low back pain, hip pain (sciatica), jaw pain (TMJ), or any dental pain/problem"

  • "Strengthens a weakened nervous system; especially helpful for problems of nerve exhaustion such as depression or fibromyalgia."

  • "Helps nerves handle pain better so that healing can occur more readily, generally helps reduce any type of pain, including chronic or acute pain"

 

From literature:

  • [Under the heading Depression] "Heals inflamed nerve tissue . . ."

  • [Under the heading Healing and Repair] "Reduces pain to speed healing."

  • [Under the heading Neuropathy] "Heals the myelin sheathing of nerves . . ."

  • [Under the heading Pain Reduction] "The best single product for low back pain, sciatica, hip pain, jaw pain and dental pain."

 

Tri – Cal

From your website :

  • "Helps . . . lower cholesterol by enhancing the formation and flow of bile. . ."

 

Cardio Helper

From your website :

  • "Helps lower high blood pressure"

  • "Helps stabilize irregular heart beats .. ."

  • “It can be used with or without any cardiovascular medication (except digoxin/digitalis - as it has an opposite effect; i.e., digoxin may cause arrhythmias whereas Hawthorne gets rid of them)."

 

From literature:

  • "[L]owers BP."

 

From the label:

  • "It may also help reduce blood pressure by improving electrolyte status and lymphatic function."

 

Chondroitin Plus

From your website:

  • "Helps prevent migraine headaches"

  • "We also add high potency feverfew, a proven herb for arthritic pain and migraine headache prevention."

 

From literature:

  • "Reduces arthritic pain."

  • "Helps prevent headaches."

  • " [Under the heading Headaches] "Contains a high level of feverfew that can prevent headaches ."

  • " [Under the heading Healing and Repair] "[R]educes pain."

 

Super CLA

From your website:

  • "Reduces hypoglycemia, helps prevent diabetes"

  • "CLA has been known about since the 1940s, but nutritional interest began when researchers at the University of Wisconsin were looking for compounds in cooked meat that could cause cancer. Much to their delight, they stumbled onto a compound in cooked meat that could possibly prevent cancer . .. . [T]hey were able to determine that this compound was CLA."  

  • "Recent research has shown that CLA can help prevent hypoglycemia by helping to correct insulin sensitivity (making it so that blood sugar can enter cells correctly) . . .The scientists were so excited about the ability of CLA to fix impaired glucose tolerance that they concluded `CLA may prove to be an important therapy for the prevention and treatment of diabetes."

 

From literature:

  • [Under the heading Cancer Risk Reduction and Support] "Higher amounts of CLA in breast tissue may reduce breast cancer risk."

 

Colloidal Silver

From literature:

  • "[Under the heading T=mune System Protection] "A po:.verful natural and non-toxic germicidal and anti-viral product."

 

Daily Balancer™

From your website:

  • "Prevents and possibly reverses mutagenic cell changes"

  • "Helps fibromyalgia and chronic fatigue syndrome"

From literature:

  • [Under the heading Cancer Risk Reduction and Support] "Reduces liver inflammation and protects the liver from damage."

  •  [Under the heading Detoxification and Liver Support] "[H]elps headaches and toxic fatigue."

  •  [Under the heading Fibromyalgia] "Clears headaches . . ."

 

Daily Protector

From your website:

  • "Helps prevent macular degeneration . . ."

 

From literature:

  • "Protects eyes, skin, reproductive organs, and all cells from mutagenic free radical damage."

  • "High amounts of lycopene, proven to reduce prostate-cancer risk."

  •  "Contains synergistic carotenes, flavonoids, and cofactors that make up for a lacking diet-all of which reduce male cancer risk."

 

Daily Super E

From your website:

  • "Most effective natural compound known for lowering high cholesterol . . "

  • "Has demonstrated a reversal of plaque build-up in arteries in individuals with significant health problems."

  • "Highly effective for preventing platelet aggregation, more effective than aspirin."

 

From literature:

  • [Under the heading Cancer Risk Reduction and Support] “Tocotrienols that have been shown to reduce breast cancer risk."

Fiber Plus

From your website:

  • "Helps lower cholesterol . . ."

  • "Helps prevent hypoglycemia . . ."

  • "Helps reduce colon cancer risk"

 

Gluco Plus

From your website:

  • "Prevents hypoglycemia"

  • "Lowers triglycerides and LDL cholesterol .. ."

  • "Excellent nutritional support for anyone who is diabetic or had pre-diabetic metabolic problems"

  • "[H]elps prevent glaucoma"

 

From literature:

  • [Under the heading Sugar Cravings/ Regulating Blood Sugar] "[H]elps reduce high blood sugar levels."

 

Immune Plus

From your website:

  • "Helps clear body aches associated with illness, allergy, or fibromyalgia"

  • "Has natural 'vaccine like' properties . . ."

  • "Very effective at preventing and helping to clear ear infections"

  • "Helps bring down a fever (use high doses)"

 

From literature:

  • [Under the heading Allergies and Congestion] "Clears congestion and mucous, preventing the lymph system from getting overloaded."

  • [Under the heading Cancer Risk Reduction and Support] "[E]xcellent for reducing breast pain."

  • [Under the heading Immune System Protection] "Helps prevent germs from `sticking,' enhances germ surveillance."

 

Leptinal™ - The Lentin Helper™

From your website:

  • "Helps lower blood pressure and lower LDL cholesterol"

 

From literature:

  • [Under the heading Arthritis] "Anti-inflammatory formula."

  • [Under the heading Cancer Risk Reduction and Support] "Reduces inflammation signals linked to obesity that increase cancer risk."

 

MONOLAURIN

From the label:

  • "[T]his product is a specially prepared monoglyceride that has been scientifically demonstrated to have a wide range of antiviral, antibacterial, and antifungal activity."

RelaxaMag (formerly called Tri Mag)

From your website:

  • "Helps lower blood pressure by relaxing the vascular system . . ."

  • "Helps stop or prevent tension headaches . . ."

 

From literature:

  • [Under the heading Cholesterol] "Unique magnesium to help lower cholesterol and prevent plague."

  •  

From your label (for Tri-Mag):

  • "[H]elps lower blood pressure and supports a more stable heart rhythm."

 

Oregano oil

From your website:

  • "A Powerful Anti-Fungal"

  • "An AL Purpose Anti-Bacterial"

  • "Capsules may be opened and applied topically to any skin problem /infection."

 

From literature:

 

  • [Under the heading Acne] "Kills bacteria and yeast. . ."

  • [Under the heading Allergies and Congestion] "Helps clear sinus infection and congestion ."

  • [Under the heading Candida] "Strong anti-fungal oil; fights sinus infections."

  • [Under the heading Immune System Protection] "Powerful broad spectrum antiseptic.

  • [Under the heading Lymphatic Congestion] "[H]elps clear infection from lymph."

Pantethine

From your website:

  • "Reduces LDL cholesterol and triglycerides, . . .and protects against hardening of the arteries"

  • "Protects against the formation of cataracts"

 

Performa Plus™

From your website:

  • "Helps lower blood pressure."

 

From the label:

  • "The nutrients in Performa Plus™ are designed to restore natural balance in the production of nitric oxide (NO) . . . . Enhancing NO formation is beneficial for . . . helping to reduce blood pressure if it is high."

 

Preventor Plus™

From your website:

  • "Helps correct hormone imbalances for women and men that otherwise increase cancer risk."

 

  • "Improves cellular health to help all cells have more resistance to mutation and DNA damage ."

  • "Directly interferes with the cellular reproduction of cancer cells as well as directly inducing the death of cancer cells."

From the label:

  • "Preventor Plus contains nutrients that help prevent the improper metabolism of estrogen and testosterone. Improper metabolism of sex hormones can increase the risk for developing hormone related cancer."

 

From literature:

  • [Under the heading Cancer Risk Reduction and Support] "Reduces hormone imbalance that initiates and/or perpetuates problems."

 

Super CoQ10

From your website:

  • "Numerous cardiovascular studies have shown that Q10 can help high blood pressure, congestive heart failure, cardiomyopathy, angina, irregular heart beat, and mitral valve prolapse."

 

Quercetin
From your website:

  • "Helps asthma"

  • "Reduces breast cancer risk and helps prevent a reoccurrence of breast cancer"

 

From literature:

  • [Under the heading "Allergies and Congestion] "Very effective antihistamine and anti-allergen."

  •  [Under the heading Cancer Risk Reduction and Support] "More effective than Tomoxifen [sic] at binding to EBS type II receptors in breast tissue."

 

Repair Plus

From your  website:

  • "[H]elps reduce cholesterol"

  • "[H]elps asthma . . ."

  • "[H)as anti-mutagenic properties"

 

From literature:

  • [Under the heading Arthritis] "Powerful nutritional anti-inflammatory that speeds healing and reduces pain."

 

  • [Under the heading Healing and Repair) "Powerful anti-inflammatory that reduces swelling and pain and speeds healing."

Saw Palmetto

From your website:

  • "Reduces Enlarged Prostate (BPH)"

  • "Prevents Prostate Enlargement"

Stress Helper™

From your website:

  • "Lowers elevated LDL cholesterol . . ."

 

Super EFA

From your website:

  • "Reduces plaquing of arteries"

  • "[H]elps reduce high blood pressure"

 

  • "[H]elps keep blood cells from inappropriately sticking together"

Super Immune Booster

From your website:

  • "Use for prevention, especially during the bug season or when around ill individuals."

From the label:

  • "Individuals with weak immunity can use it preventatively (sic) during the bug season or an a regular basis to help overcome chronic low grade issues."

 

From literature:

  • [Under the head', Blood Pressure] "Olive leaf extract lowers BP"

  • [Under the heading Candida] "Clears intestinal tract yeast."

  • [Under the heading Sleep: Restorative Sleep] "[R]educes blood pressure."

 

Tea Tree Oil

From literature: "Topical antiseptic oil”

From the label:

  • "Antiseptic"

  • "Pharmaceutical grade Tea Tree Oil containing 40% Terpinen-4-ol, the highest concentration of active antiseptic ingredient . . . ."

  • "Use topically for minor cuts/scrapes, nail fungus, insect bites, stings, and minor burns."

Thyroid Helper™

From your website:

"Lowers LDL cholesterol . . ."

Structure /Function Claims:

Under section 201(g)(1)(C) of the Act [21 U.S.C. 321 (g)(1)(C)], articles (other than food, including dietary supplements] intended to affect the structure or any function of the body of man are drugs. Claims that appear on your product labeling, including literature that you distribute to customers, promote some of your products for conditions that cause the products to be drugs under section 201(g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(C)]. The claims establish that the products are drugs because they are intended to affect the structure or function of the body. Examples Of structure/ function claims found in literature for your topical products include:

Femme Balance Moisture Treatment Crème

[Under the heading "Balance Female Hormones"]

  • "Weight Loss Tip #14-Imbalances in female hormones lead to stuck issues regarding weight loss if not managed properly."

  • "Controls hot flashes and other menstrual symptoms."

  • "Helps build new bone and prevent bone loss."

  • "The most effective form of estrogen for protecting the brain, helps memory." -

  • "Helps bladder incontinence."

  • "Helps vaginal dryness and atrophy."

  • "Femme Balance contains natural estriol and progesterone for female hormone balance and support."

 

[Under the heading "Steps to Effectively Build Bone and Prevent Bone Loss!"]

  • "femme balance . . . . Estriol, . . . has been shown to enhance bone density in older women."

 

Pro Femme Natural Body Cream for Women

[Under the heading `Balance Female Hormones"]

  • "Weight Loss Tip ' # 14-Imbalances in female hormones lead to stuck issues regarding weight loss if not managed properly."

  • "Controls hot flashes and other menstrual symptoms."

  • "Helps build new' bone and prevent bone loss ."

  • "Hormonal support for improving HDL cholesterol."

  • "Helps symptoms associated with PMS, especially headaches, depression, irritability, mood swings, fluid retention, or bloating."

  • "Helps problems of estrogen dominance: breast swelling and tenderness, fibrocystic breasts, uterine fibroids, endometriosis, or heavy menstruation."

 

The disease claims and structure/ function claims on your product labeling cause your products to be drugs, as defined in sections 201(g)(1)(B) and 201(g)(1)(C) of the Act [21 U.S.C. §321(g)(1)(B) and (C)]. Because the products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p)) of the Act [21 U.S.C. 321(p)]. Under section 505(a) of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA) [21 U.S.C. 355(a)].

Furthermore, the labeling for a number of your products [Black Currant Oil, Calcium- AEP, Tri-Cal, Cardio-Helper, Super CLA, Colloidal Silver, Daily Balancer™, Daily Super E, Fiber Plus, Gluco Plus, Immune Plus, Leptinal™, Monolaurin, RelaxaMag (formerly Tri-Mag), Oregano Oil, Pantethine, Performa Plus™, Preventor Plus™, Super CoQ 10, Quercetin, Repair Plus, Saw Palmetto, Stress Helper™, Super EFA, Super Immune Booster, Thyroid Helper™, and Pro Femme Natural Body Cream for Women] indicates that they 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. These products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] in that the labeling does not bear adequate directions for use.

Other Labeling Deviations:

Your products Activator Plus and Repair Plus are misbranded within the meaning of sections 403(i)(1) and 403 (s)(2) (B) of the Act [21 U.S.C. 343(1)(1) and 343(s)(2)(B)] because the labels fail to identify the product with the term "dietary supplement" (or an appropriate alternative) as part of the statement of identity on the principal display panel, as specified in 21 CFR 101.3(d) and 21 CFR 101.3(g).

We request that you take prompt action to correct these violations. Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct these violations, including any steps taken with violative products currently in the marketplace, and an explanation of each step taken to ensure that violations do not recur. Also include copies of any available documentation demonstrating that your corrections have been made. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Failure to immediately cease distribution of your violative products could result in enforcement action by FDA without further notice. The Act provides for the seizure of illegal products and injunctions against the manufacturers and/or distributors of violative products.

In addition to the violations described above, FDA has the following comments concerning the labeling of your products.

The following statements are made on the labels for your products Fiber Plus and Fiber Helper™: "Wellness Resources Fiber Plus [Fiber Helper] does not contain: . . . oats . . ." However, the nutrition labeling (Supplement Facts) for your products Fiber Plus and Fiber Plus declares that they contain oat fiber (Avena sativa) and Oat bran concentrate (standardized to contain 54% oat beta glucan), respectively.

If you intend to market your products as dietary supplements (for example, Oregano Oil), please be aware that you must meet the statutory requirements found in section 201(ff) of the Act [21 U.S.C. 321(f). In particular, section 201(ff)(2) of the Act requires that dietary supplements be in a form that is intended for ingestion (e.g., tablet, capsule, liquid form  etc.). Your website includes directions of use for topical application of Oregano Oil.

This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility, as president, to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You can find the Act and FDA's regulations through links on FDA's Internet website at http://www.fda.gov.

Your reply should be directed to Compliance Officer Brian D. Garthwaite, Ph.D., at the address indicated oil the letterhead.

Sincerely,
/s/
W. Charles Becoat
Director
Minneapolis District