Inspections, Compliance, Enforcement, and Criminal Investigations
Priority One Nutritional Supplements, Inc. 05-Apr-05
Department of Health and Human Services
Public Health Service
April 5, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-18
Danielle S. Baumgart, President
Priority One Nutritional Supplements, Inc.
7157 Guide Meridian, Suite 10
Lynden, Washington 98264
Dear Ms. Baumgart:
The Food and Drug Administration (FDA) inspected your firm located at 7157 Guide Meridian, Suite 10, Lynden, Washington, on January 4-6 and 18-21, 2005. During the inspection our investigator collected labels and the product reference guide that accompanies some of your sold product. In addition, we reviewed your website at the Internet address www.priorityonevitamins.com. Our review of the information collected during the inspection and your website found 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 www.fda.gov.
Dietary Supplements with 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. Based on claims that appear in the labeling for your products, including on your website and in the product reference guide that accompanies some product shipments, we have determined that a number of your products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B). The therapeutic claims on your website and in your promotional materials 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 on your website and in your product catalog include:
"May Be Helpful For . . . Reducing tumors . . ."
"May Be Helpful For . . . Diabetes . . . High blood pressure"
"Benefits . . . Immuno Plus `m can help to prevent or stop common immune problems . . . . Strong immunity is very important to prevent the development of cancer and other autoimmune [product reference guide states "immune"] diseases."
"May Be Helpful For . . . Arthritis ; Gout; Varicose veins; day blindness; diabetic retinopathy; cataracts; glaucoma; Preventing strokes . . ."
"May Be Helpful For . . . Alzheimer's disease."
Caprylic Plus TW™
"Description . . . An antifungal . . . preferred by thousands of physicians over the prescription drug Nystatin for the control of candida albicans ."
"May Be Helpful For . . . Cancer Prevention . . . Bursitis . . . Osteoarthritis . . ."
"May Be Helpful For . . . Reducing cholesterol and triglycerides . . . Preventing heart disease and atherosclerosis . . ."
"May Be Helpful For . . . Prostate Cancer . . ."
Heart Guard Plus™
"May Be Helpful For . . . Atherosclerosis . . . Angina . . . Hypertension . . . Mitral Valve Prolapse Emphysema . . . High blood pressure . . . Blood clots"
Anti-Stress™B and C w/Adrenal
"May Be Helpful For . . . diabetes, candidiasis . . . cancer; depression . . . manic episodes . . . paranoia . . ."
"May Be Helpful For . . . Diabetes . . . Hypoglycemia"
"May Be Helpful For . . . Psychiatric disorders . . . depression; anxiety . . . substance abuse; bulimia; seasonal affective disorder ; childhood hyperactivity; and schizophrenia . . . . Neurological conditions including Parkinson's disease, tardive dyskinesia, akathisia, dystonia, Huntington's disease, myoclonus, Tourette's syndrome, and multiple sclerosis. Also . . . dementia . . . Migraine . . . Fibromyalgia pain . . . ."
Your product reference guide also includes a "Diagnostic Index" listing numerous conditions which include diseases such as AIDS, Alzheimer's disease and diabetes . Underneath the name of a particular disease are a list specific products, implying that the products are intended to treat, cure, mitigate, or prevent the disease(s) under which they are listed . Your website also lists conditions with direct links between your products and particular diseases, implying that those products are intended to treat, cure, mitigate or prevent the disease(s) they are linked to.
Because your products are not generally recognized as safe and effective for the above referenced conditions, your products are also new drugs under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. 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.
Misbranded Dietary Supplement Products
Based on your products' label, which contain a "Supplement Facts" panel, it appears that you intend to market your products as dietary supplements . Even if your product labeling did not include claims that cause them to be drugs, many of your products would be misbranded dietary supplements for the reasons set forth below.
Unsubstantiated Structure/Function Claim
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 catalog contain the following structure/function claim for Carb Blocker R™
"The main ingredient white kidney bean extract has been shown to help reduce the uptake of carbohydrates in the diet."
We have reviewed this claim and have concluded that it is not supported by competent and reliable scientific evidence. Because this claim lacks substantiation, it is false or misleading, and causes your product to be misbranded under 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
The products listed above 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 products with the term "dietary supplement" (or an appropriate alternative authorized by regulation) as part of the statement of identity, on the principal display panel, as specified in 21 CFR 101.3(d) and (g).
Numerous products fail to present nutrition information required by section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in a Supplement Facts panel in the format required under 21 CFR 101.36. For instance, 5-Hydroxy-Tryptophan 50 mg, Absorb B™, Flavonoid Plus", and Vana-Trace" 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).
This letter is not: intended to be an all inclusive review of your products. 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.
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 assure that violations do not recur. Your reply should be sent to the Food and Drug Administration, Attention: Lisa Althar, Compliance Officer, 22201 23rd Drive Southeast, Bothell, Washington 98021-4421.
Charles M. Breen