Inspections, Compliance, Enforcement, and Criminal Investigations
MotherSOY(R), Inc. 24-Oct-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
October 24, 2006
Dr. Carl K. Barniak
424 S . Kentucky Ave
Evansville, IN 47714
Dear Dr. Barniak:
In conjunction with an inspection of your firm on June 26-29, 2006, the Food and Drug Administration (FDA) reviewed your firm's website www.mothersoy.com, as it appeared on July 11, 2006. Our review of your MotherSOY® Essential IsoFlavones and Essential Protein products found serious. violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of these products . You can find the Act and implementing regulations through links on FDA's internet home page at www.fda.gov.
Under the Act, articles intended for use in the-diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [section 201(g)(1)(B) of the Act, 21 U.S.C. 321 (g)(1)(B)] . Based on the claims that appear on your website for your MotherSOY® Essential IsoFlavones and Essential Protein products, we have determined that these products are drugs under section 201(g)(1)(B). The therapeutic claims on your website established 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 disease claims observed on your website for these products include the following:
Under headine "The Doctors Agree"
"MotherSOY® "Essential IsoFlavones" is high in isoflavones and is ideal for a balanced approach to nutrition and health maintenance, which includes lowering
risks for cancer . . . ."
"MotherSOY® protein lowers cholesterol. Populations that eat the most soy protein have the least heart disease."
Under heading "What Doctors and Medical Professionals are saying about MotherSOY® Protein"
"We have seen consistently exceptional results with a wide variety of health problems including, but not limited to reduction in LDL cholesterol, hypertension, . . . chronic fatigue syndrome . . . ."
"[W]ith the added benefits of lowering the risk of cardiovascular disease. . . ."
"Many patients with chronic lower back or neck pain have low serum albumin. When MotherSOY®'s protein is added to their diet, their pain has diminished
and their serum albumin levels have increased."
Under headinig "Personal Success Stories"
"I developed two blockages of over 70% in major heart arteries . . Rather than having a bypass operation, I tried to radically change my diet. I have been using the MotherSOY® "Essential Protein" in a blender each morning and the blockage has been significantly reduced to the point that I no longer have any angina pains."
Other objectionable claims include the following: prevention of obesity, diabetes, heart disease, liver and kidney failure, and cancer.
This list of claims is not intended to be all-inclusive, but represents the types of claims found on your product labeling.
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 USC 321(p)]. Under section 505 of the Act [21 USC 355], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new drug on the basis of scient'rfic data submitted by a drug sponsor to demonstrate that the drug is safe and effective. These drugs are also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that their labeling does not bear adequate directions for use.
Other Labeling Deviations
Even if your MotherSOY® Essential IsoFlavones and Essential Protein products did not contain disease claims in their labeling that cause them to be drugs, they would still be misbranded as foods under section 403(q) of the Act [21 USC 343(q)] because the nutrition label does not provide all of the information required by 21 CFR 101.9(c) and is not provided in one of the formats required by 21 CFR 101.9(d) or (f).
For example, the labels fail to declare trans fat [21 CFR 101.9(c)(2)(ii)], fail to be set off in a box by use of hairlines [21 CFR 101.9 (d)(1)(i)], and fail to declare the percent Daily Values of the nutrients [21 CFR 101 .9(c)] including nutrients for which nutrient content claims are being made.
Additionally, your MotherSOY® Essential IsoFlavones and Essential Protein products would be misbranded as foods under section 403(r)(1)(A) for making unauthorized nutrient content claims . Your MotherSOY® Essential IsoFlavones products claim to be "Very High in . . .soy isoflavones." FDA has authorized nutrient content claims for "high" and "good source," but there are no authorized claims for "very high." In addition, authorized nutrient content claims are limited to substances that have a Reference Daily Intake (RDI) or Daily Reference Value (DRV), and there is no RDI or DRV for isoflavones [21 CFR 101.54] . Also, your Essential Protein products bear the claim "Extremely High Potassium," but there is no authorized claim for "Extremely High."
Furthermore, your MotherSOY® Essential IsoFlavones and Essential Protein products would be misbranded as foods under section 403(r)(1)(B) for making an unauthorized health claim on your website. In particular, your website makes the following unauthorized health claim:
"Twenty-five (25) grams of soy protein a day, as a part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."
The claim is unauthorized because it fails to meet all of the requirements of 21 CFR 101.82(c)(2)(G). Specifically, the claim must specify the contribution one serving of the product makes to the specified daily dietary intake level.
The above violations are not intended to be an all-inclusive list of deficiencies 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. You must immediately correct these violations . If you do not immediately correct them, you may be subject to enforcecaent action without further notice : The Act provides for the seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 U.S.C. 332 and 334] . Additionally, we note that your website makes the following claim:
"Foods containing at least 350 mg of potassium and less than 140 mg of sodium may reduce the risk of high blood pressure and stroke:"
This claim is a derivation of a health claim authorized by the Act [under section 403(r)(3)(C)] for potassium/ hypertension and stroke. Under the provisions of the Act, when a health claim based on an authoritative statement is used, it must appear exactly as stated in the notification that proposed the claim, i.e., "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke."
Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will take to correct these violations, including the steps taken to assure that similar violations do not recur.
Your reply should be directed to Paige E. Wilson, Compliance Officer at the above address.
Joann M. Givens
Detroit District Office