|Company:||Vitality Products Co., Inc.|
|Issuer:||Seattle District Office|
|Issued:||June 17, 2005||Closed:||
Department of Health and Human Services
Public Health Service
June 17, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-24
Lloyd W. Brooks, President
Vitality Products Co ., Inc .
6330 Tamoshan Drive Northwest
Olympia, Washington 98502-3454
Dear Mr. Brooks:
The Food and Drug Administration (FDA) inspected your firm located at 6330 Tamoshan Drive Northwest, Olympia, Washington, on March 3 and 8, 2005, and April 15, 2005. During the inspection, our investigator collected labeling for your products, including literature that is included in product shipments. In addition, we reviewed your website at the Internet address www.vitalityproducts.com . Our review of the labeling collected during the inspection and listed on your website identified numerous violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet web site at http://www.fda.gov.
Your products' labeling includes the following violations of the Act:
Dietary Supplements Without Iron Statement:
1. "CAL-MAG Zinc-Plus with AMINO ACID CHELATES" and "Two-A-Day Multi-Vitamin with Chelated Minerals" 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 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 with Disease Claims:
2. 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. Based on claims that appear in the product literature you distribute with product shipments, and claims made on your website at http//www.vitalityproducts.com , we have determined that some of your products are promoted 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 therapeutic claims 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 observed in your products' labeling, including your website and literature accompanying your products, include:
"Natural Relaxation Magnesium Citrate Powder"
From your literature : "Magnesium Citrate . . . helps avoid heart attacks, cures most heart attacks . . . lowers high blood pressure . . . magnesium reverses osteoporosis, depression, anxiety attacks . . . ."
"Eternal Youth Age Reversal Formula Human Growth Hormone Releaser"
From your literature and website: "Improvement in cholesterol profiles" and "Lowered blood pressure"
" Highest Potency Acidophilus"
From your website and product literature : "Acidophilus helps . . . fight cold sores and fever blisters . . . fight yeast infections (Candidiasis) ."
From your website: "[R]ecommended for helping cases of venous distention (hemorrhoids and varicose veins) ."
From your website : "Laboratory studies show garlic kills viruses, excellent for both high and low blood pressure, infection . . . ."
"Stabilized Rice Bran"
From your literature and website: "SRB . . . can promote positive benefits for many conditions including : Arthritis, diabetes, fibromyalgia, . . . high blood pressure/cholesterol, degenerative conditions, MS, . . . depression, . . . psoriasis ."
From your literature: "Some of the nutrients found in SRB [Stabilized Rice Bran] include: . . . IP6 (a strong antioxidant known to help prevent deposition of cholesterol in arteries and prevent formation of kidney stones)."
From your website: "Some of the nutrients found in the SRB [Stabilized Rice Bran] include: . . . IP6 (a strong antioxidant know [sic] to help formation of kidney stones)."
From your website: "Helps build white blood cells and improves resistance to infection."
Because these 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 of the Act (21 U.S.C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). These products are also 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.
Unsubstantiated Structure/Function Claims:
3. Under the Act, dietary supplements may be legally marketed with claims that they affect the structure or function of the body (structure/function claims) if certain requirements are met. Section 403(r)(6)(B) of the Act [21 U.S .C. 343(r)(6)(B)] requires the manufacturer of a dietary supplement containing a "structure/function" claim in the product's labeling to have substantiation that the claim is truthful and not misleading.
Your website and product literature for "Eternal Youth Age Reversal Formula Human Growth Hormone Releaser" contain the following structure/function claims for this product:
"8.8% increase in muscle mass without exercise
" 14.4% decrease in body fat without dieting
" Elimination of cellulite
"Improved sexual performance
" Increased memory
" Stronger immune system
" Hair re-growth
" Disappearance of wrinkles . .
" Stronger bones"
We have reviewed these claims and have concluded that they are not supported by reliable scientific evidence. Because the claims lack substantiation, they are false or misleading, and cause your products to be misbranded within the meaning of sections 403(a)(1) and 403(r)(6.)(B) of the Act [21 U.S .C. 343(a)(1) and 343(r)(6)(B)].
Other Labeling Deviations:
4 . "CAL-MAG Zinc-Plus with AMINO ACID CHELATES", "Complete Multi-Vitamins with Minerals", and "Fibromyalgia Formula Support" are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they contain ingredients that are not declared on the label. Each of the products is contained in a capsule, but the capsule ingredient (i.e., gelatin) is not listed as required by 21 CFR 101.4.
5. "CAL-MAG Zinc-Plus with AMINO ACID CHELATES", "Two-A-Day Muiti-Vitamin with Chelated Minerals", "Complete Multi-Vitamins with Minerals", "Fibromyalgia Formula Support", and "Natural Relaxation Magnesium Glycinate" are misbranded under sections 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. 343(i)(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 (g).
6. "CAL-MAG Zinc-Plus with AMINO ACID CHELATES" and "Two-A-Day Multi-Vitamin with Chelated Minerals" are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because they do not present nutrition information in a Supplement Facts panel in the format required under 21 CFR 141.36. For instance, they do not list the title "Supplement Facts" bolded and in a type size larger than all other print size in the nutritional label, and the Supplement Facts information is not enclosed in a box using hairlines and does not contain heavy bars where required, as specified in 21 CFR 101.36(e)(1), (2) and (6).
In addition, "CAL-MAG Zinc-Plus with AMINO ACID CHELATES" and "Two-A-Day Multi-Vitamin with Chelated Minerals" are further misbranded within the meaning of sections 403(q)(1)(A) and (B) of the Act because the product labels fail to list the subheadings "Serving Size" and "Servings Per Container," as required by 21 CFR 101 .9(b)(1) and 21 CFR 101.9(b)(8), respectively.
This letter is not intended to be an all inclusive review of your products and labeling . It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
We request that you take prompt action to correct these violations. 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, injunctions against the manufacturers and/or distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act.
For your information, if you intend to market your products as dietary supplements (for example, Mehylcobalamin Sublingual Vitamin B12 (1000mcg) with Folic Acid (Vitamin B9)), please be aware that you must meet the statutory requirements found in section 201(ff) of the Act [21 U.S.C 321(ff)]. In particular, section 201(ffj of the Act states that dietary supplements must be in a form (i .e., tablet, capsule, liquid form, etc .) that is ingested.
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 respect to violative products currently in the marketplace, and an explanation of each step taken to ensure that violations do not recur. Your reply should be sent to the Food and Drug Administration, Attention: Lisa Althar, Compliance Officer, 22201 23`d Drive SE, Bothell, Washington 98021-4421.
Charles M. Breen