| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human Services
WARNING LETTER
11-PHI-1
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 1, 2010
Connie M. Geddes, President/Owner
Vitality Products Company, Inc.
1005 Pinnacle Way
Greensburg, PA 15601
Dear Ms. Geddes:
The Food and Drug Administration (FDA) conducted inspections at your firm located at 1005 Pinnacle Way, Greensburg, PA, from April 13, 2010 through April 14, 2010 and from June 30, 2010 through July 7, 2010. Over the course of these inspections, our investigators collected documentary samples, "labeling, and promotional literature associated with your products. In addition, we reviewed your website at the Internet address www.vitalityproducts.com in October, 2010. Our review of the information collected during the inspection and on your website indicates serious 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 website at http://www.fda.gov.
Unapproved New Drugs:
Based on claims that appear on the product labels, in the product literature you distribute with product shipments, and claims made on your internet website at http://www.vitalityproducts.com, we have determined that your "Arthritis Nutritional Support with Glucosamine Sulphate (90 and 180 Capsules)," "Oral Chelation with EDTA (180 Capsules)," "Natural Relaxation Magnesium Glycinate (180 Capsules)," "Highest Potency Acidophilus (100 and 180 Capsules), "Prostate Nutritional Support (100 and 200 Capsules)," "Stabilized Rice Bran (16 oz)," and "Collinsonia Root (125 Capsules)" 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 on your product labels, in your product literature, and on your internet website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. Examples of the disease claims on your product labels, in your product literature, and on your internet website include:
1. Arthritis Nutritional Support with Glucosamine Sulphate (90 and 180 Capsules):
The statement of identity on the product bottle labels:
• "Arthritis"
Vitality website: www.vitalityproducts.com:
• "Arthritis Formula from VITALITY PRODUCTS CO. INC. contains all-natural dietary supplements developed for the support of arthritis and joint pain."
•"Arthritis Formula from Vitality Products Co. Inc. contains a multitude of very high quality ingredients including Glucosamine Sulphate, Vitamin D, B6, B5, Niacinamide, Potassium, Magnesium plus many more herbs that may help to support arthritis conditions."
2. Oral Chelation with EDTA (180 Capsules):
Product Insert:
• "Supports the Removal of Plaque...[w]hen plaque builds up in blood vessels, blood flow (carrying oxygen and nutrients) is restricted.. .If there is excessive plaque buildup and the vessels become partially or completely blocked, not enough blood can reach the body's tissues. Hardening of the arteries is not localized or segmental disease. It does not affect only one part of the body at a time. If coronary arteries are clogged with plaque, its [sic] possible arteries and veins in other area may be in a similar state."
• "MALIC ACID, included in our dietary supplement. .. [i]n particular, malic acid's involvement in the Krebs cycle means.. .it a beneficial support for sufferers of fibromyalgia (which involves muscle pain, joint tenderness and poor energy levels) and Chronic Fatigue Syndrome (CFS), which produces similar symptoms."
3. Natural Relaxation Magnesium Glycinate (180 Capsules):
Product Insert:
• "Magnesium deficiencies have been tied to symptoms of allergies, asthma, attention deficit disorder, anxiety, depression, heart disease... "
• "HIGH BLOOD PRESSURE: Large studies have linked magnesium deficiency to high blood pressure. 'Some researchers say that, as a nation, we could cut our rate of heart disease by one-half if we took more magnesium, says City Island, N.Y.-based Carolyn Dean, MD, ND, author of 'The Miracle of Magnesium'. 'Magnesium is the body's natural calcium channel blocker. It balances out the excess calcium that is associated with the heart going into muscle spasm, which equals a heart attack."
• "With all the research linking low magnesium intake with high cardiovascular risks, this low-cost mineral would appear to be a simple way to counter today's heart attack and stroke epidemic."
• "I believe that the cure for depression is often extremely simple and quick using magnesium rather than drugs for many people."
• "DIABETES: Data from the Nurses' Health Study and the Harvard School of Public Health back up Dean's claims. Higher intake of magnesium may reduce the risk of developing type 2 diabetes."
4. Highest Potency Acidophilus (100 and 180 Capsules):
Product Insert:
• "Many things can deplete good bacteria: ... antibiotics, disease, viruses .... When these factors come into play, bad bacteria can multiply and take over, possibly leading to a variety of intestinal problems, candida albicans, urinary tract infections and yeast infections. Acidophilus and supportive probiotics may help to restore balance."
• "Lactobacillus Acidophilus has anti-fungal properties."
5. Prostate Nutritional Support (100 and 200 Capsules):
Product Insert:
• "This dietary supplement contains a high concentration of beta sitosterol. ..Beta-Sitosterol Benefits Documented: ...published scientific studies that prove beta-sitosterol is an extremely effective, natural treatment for an enlarged prostate."
• Beta-Sitosterol References: www.swedish.org 4. Wilt TJ, MacDonald R, Ishani A. Beta-sitosterol for the treatment of benign prostatic hyperplasia:"
6. Stabilized Rice Bran (16oz):
Product Insert:
• "Doctors & Scientists recommend an increase in fiber for disease prevention and treatment of the following: Heart Disease, Constipation, Cancer (especially of the colon), Hemorrhoids, Diverticulosis, Varicose Veins, Obesity and Diabetes... Stabilized Rice Bran contains healthy fiber ... "
7. Collinsonia Root (125 Capsules):
Product bottle label:
• "Has been very helpful in relieving cases of enlarged blood vessels such as hemorrhoids and varicose veins."
Additionally, these products are not generally recognized as safe and effective for the above referenced uses and, therefore, they 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)]. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your "Oral Chelation with EDTA (180 Capsules)," "Natural Relaxation Magnesium Glycinate (180 Capsules)," "Highest Potency Acidophilus (100 and 180 Capsules)," "Prostate Nutritional Support (100 and 200 Capsules)," "Stabilized Rice Bran (16 oz)," and "Collinsonia Root (125 Capsules)" products are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fails to bear adequate directions for use.
Misbranded Dietary Supplements:
Even if your "Arthritis Nutritional Support with Glucosamine Sulphate (90 and 180 Capsules)," "Oral Chelation with EDTA (180 Capsules)," "Natural Relaxation Magnesium Glycinate (180 Capsules)," "Highest Potency Acidophilus (100 and 180 Capsules)," "Prostate Nutritional Support (100 and 200 Capsules)," "Stabilized Rice Bran (16 oz)," and "Collinsonia Root (125 Capsules)" products were not unapproved new and misbranded drugs, they would still be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] in that the labeling for these products does not comply with the food labeling requirements in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). In addition, your "Liver Health Complex (90 Capsules)," "Thyroid Complex (60 and 120 Capsules)", "MSM Methylsulfonylmethane Antioxidant Formula (120 Capsules)," "Blood Pressure Formula (120 Capsules)," "IP-6 and Inositol Rapid Release (120 Capsules)," and "Betaine HCL with Pepsin (100 and 250 Capsules)" products are also misbranded dietary supplements under section 403 of the Act, in that the labeling for these products does not comply with the food labeling requirements in 21 CFR Part 101.
Your products are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information on the labeling for your products does not comply with 21 CFR 101.36. Examples of the deviations from the requirements of 21 CFR 101.36 include:
• Your "Arthritis Nutritional Support with Glucosamine Sulphate (90 Capsules)" did not present nutrition information in a panel titled "Supplement Facts," as is required under 21 CFR 101.36(e)(1).
• The labels for your "Arthritis Nutritional Support with Glucosamine Sulphate (90 and 180 Capsules)," "Liver Health Complex (90 Capsules)," "Oral Chelation with EDTA (180 Capsules)," "Thyroid Complex (60 and 120 Capsules)," "Highest Potency Acidophilus (100 and 180 Capsules)," "MSM Methylsulfonylmethane Antioxidant Formula (120 Capsules)," "Prostate Nutritional Support (100 and 200 Capsules)," and "Blood Pressure Formula (120 Capsules)" products do not separate each dietary ingredient listed from the dietary ingredient listed above and beneath it by a hairline rule centered between the lines of text, as required by 21 CFR 101.36(e)(5).
• The "Supplement Facts" panels on your "Arthritis Nutritional Support with Glucosamine Sulphate (90 and 180 Capsules)," "IP-6 and Inositol Rapid Release (120 Capsules)," "Liver Health Complex (90 Capsules)," "Oral Chelation with EDTA (180 Capsules)," "Thyroid Complex (60 and 120 Capsules)," "MSM Methylsulfonylmethane Antioxidant Formula (120 Capsules)," and "Prostate Nutritional Support (100 and 200 Capsules)" product labels are not formatted in accordance with 21 CFR 101.36(b)(3)(i) because they do not separate dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) and dietary ingredients for which RDIs and DRVs have not been established with a heavy bar as required by 21 CFR 101.36(e)(6).
• The "Supplement Facts" panels for your "IP-6 and Inositol Rapid Release (120 Capsules)," "Oral Chelation with EDTA (180 Capsules)," "Thyroid Complex (60 and 120 Capsules)," "MSM Methylsulfonylmethane Antioxidant Formula (120 Capsules)," and "Prostate Nutritional Support (100 and 200 Capsules)" products are not formatted in accordance with 21 CFR 101.36(b)(2)(i) because they do not list the Reference Daily Intake (RDI) or a Daily Reference Value (DRV) for any of the dietary ingredients used in your products that are listed in 101.9(c).
• Your "Arthritis Nutritional Support with Glucosamine Sulphate" product labels fail to list the subheadings "Serving Size" and "Servings Per Container," as required by 21 CFR 101.36(b)(1)(i) and (ii).
• Your "Betaine HCL with Pepsin," "Stabilized Rice Bran," and "Collinsonia Root" products completely fail to bear nutrition information, which is required under 21 CFR 101.36, and are not exempt from this requirement
Further, many of your firm's products 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, as required by 21 CFR 101.4. For example, your "Thyroid Complex (60 and 120 Capsule)" and "Oral Chelation with EDTA (180 Capsules)" contain rice flour, but rice flour is not listed as an ingredient. In addition, your "Arthritis Nutritional Support with Glucosamine Sulphate (90 and 180 Capsules)," "Oral Chelation with EDTA (180 Capsules)," "Natural Relaxation Magnesium Glycinate (180 Capsules)," "Betaine HCL with Pepsin (100 and 250 Capsules)," "Thyroid Complex (60 and 120 Capsules)," "Highest Potency Acidophilus (100 and 180 Capsules)," "MSM Methylsulfonylmethane Antioxidant Formula (120 Capsules)," "Prostate Nutritional Support (100 and 200 Capsules)," and "Collinsonia Root (125 Capsules)" products are contained in a capsule, but the capsule ingredients (e.g., gelatin) are not listed.
Further, your "Stabilized Rice Bran" product is misbranded under section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to bear the net quantity of contents in accordance with 21 CFR 101.105. The term "net weight" should be used when stating the net quantity of contents in term of weight [21 CFR 101.105(j)(3)]. Additionally, the net weight for your 16 oz. Rice Bran product should be declared in the metric system (e.g., grams, kilograms) [21 CFR 101.105(j)(1); 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)].
We acknowledge the response that you provided to our investigators at the close of the July 7, 2010 inspection, and the corrections promised therein. Your response notes that you have implemented the use of sticker labels to declare your products as dietary supplements, and the correct address of your facility. You also informed our investigators that you are revising all of your labeling, which will take you at least one year. This amount of time appears to be excessive to make these corrections. Please include documentation in your response which shows completion of labeling corrections, or a revised date in which you anticipate making these label corrections.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
Sincerely,
/s/
Kirk Sooter
District Director
Philadelphia District
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director
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