Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Central Region
Minneapolis District

 

212 3rd Ave S
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

December 27, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Byron J. Richards, President
Wellness Resources, Inc.
7155 Amundson Ave
Edina, MN 55439

Ref. No. MIN-06-16

Dear Mr Richards:

The Food and Drug Administration (FDA) inspected your firm located at 7155 Amundson Ave, Edina, MN, 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 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 USC 343(a)(1) and 21 USC 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 USC 343(a)(1) and 21 USC 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 USC 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 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 USC 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:

Structure/Function Claims:

Under section 201(g)(1)(C) of the Act [21 USC 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 USC 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:

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 USC 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 USC 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 USC 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 USC 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 USC 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 USC 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 www.fda.gov.

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

Sincerely,
/s/
W. Charles Becoat
District Director

This page was posted on March 28, 2006.

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