WARNING LETTER

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

February 5, 2019

Nutrition Coalition Inc

Kolleen A Sunde

2420 20th Ave S

Moorhead, MN 56560

RE: 566090

Dear Ms. Sunde:        

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.nutritioncoalition.com and www.willardswater.com in October 2018 and has determined that you take orders there for your products Alpha-Lipoid Acid, Colostrum Alpha Whey III (Liquid), Colloidal Silver, CoQ10, Curcumin, Echinacea Root, Liva-Vite, L-Carnitine, Milk Thistle, Selenium, Ultimate Willard’s Water Lotion with Goat’s Milk, Vinpocetine, Vitamin B Complex, Vitamin C, Vitamin D3, Vitamin E, and Willard’s Water. The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  

Examples of some of the claims observed on your websites that provide evidence your products are intended for use as drugs include the following:

On the “Colloidal Silver – 8oz.” product webpage:

• “optimal bactericidal and viricidal activity”

On the “Echinacea Root – 60 Capsules” product webpage:

• “This herb was valued by the Native Americans and frontiersmen as a remedy for snake bites and infections from wounds.”

On the “Liva-Vite -- 120 Tablets” product webpage: 

• “Milk thistle has been used for over 2,000 years for the treatment of liver and gallbladder disorders including hepatitis cirrhosis, jaundice and to protect against liver poisons including those from snakebite, mushroom poisoning, and alcohol.” [Milk thistle extract is an ingredient in Liva-Vite.]
• “[Beet Root] … has been shown to protect against both alcoholic and non-alcoholic fatty liver disease and to actually reduce fatty liver …”
• “Black radish has been shown in animals to protect against poisoning from carbon tetrachloride and acetaminophen.”
• “Uva Ursi … ‘useful for inflammatory disorders of the efferent urinary tract’ and … it is an effective antimicrobial agent against numerous bacteria and the yeast, ‘Candida albicans’.”
• “taurine can protect against alcohol and carbon tetrachloride induced liver damage”

On your September 2010 “Possibilities” newsletter titled, “Most People Deficient in This ‘Master’ Antioxidant”:

• “[According to Dr. Mark Hyman, MD, an integrative medicine practitioner,] nearly all of his seriously ill patients are glutathione deficient, including those with chronic fatigue syndrome, heart disease, autoimmune diseases, diabetes, Alzheimer’s and Parkinson’s. . . . Dr. Hyman suggests a combination of supplements that improve the body’s glutathione-producing ability[, including] … Alpha lipoic acid … milk thistle … Vitamins B-6, B-12, and folate … Vitamins C and E … Selenium”
• “Vitamin D Could Reduce Mold Allergies”
• Support for Vitamin D’s Colorectal Cancer Prevention Abilities (reduced risk by 40%)”
• “Now, do you know which nutrient has been linked to preventing a variety of health problems including Cancers, Heart problems … Alzheimer’s …? It may fight off degenerative brain diseases like Alzheimer’s … ‘this nutrient’ is CoenzymeQ10 or ‘CoQ10’”

On your April 2012 “Possibilities” newsletter titled, “Avoiding Alzheimer’s … Possibilities Involving Two Nutrients Plus Eleven Other Tips”

• “There has been quite a lot of research indicating that Vitamin D is helpful in fighting Alzheimer’s Disease … and also quite a lot of research to say that Curcumin … also helps fight off that horrible disease.”
• “Prior studies have found that it [curcumin] may help inhibit the accumulation of the components of the tangles and plaques that are linked to Alzheimer’s disease in the brains of Alzheimer’s patients, as well as breaking up already-existing plaques. Researchers concluded Curcumin … [i]s more effective at inhibiting the forming of protein fragments than many other potential Alzheimer’s treatments[, and that] Alzheimer’s symptoms caused by inflammation and oxidation are easy by curcumin’s powerful antioxidant and anti-inflammatory properties”
• “They also think Vitamin D may, like Curcumin, impact Alzheimer’s positively partly due to its anti-inflammatory … abilities.”
• “[P]eople who consume diets rich in B-12 may reduce their risk of Alzheimer’s in later years.”
• “Alpha Whey III Liquid Colostrum … [people] don’t ever seem to get colds any more. Many others also say they haven’t had the flu since they started using Alpha Whey III routinely.”
• “Colostrum … people say it’s been of benefit to them … from stomach ulcers to … arthritis” 

On your April 2013 “Possibilities” newsletter titled, “FIGHTING AGING, PARKINSON’S, ALZHEIMER’S & MORE?”

• “L-Carnitine is also said to help fight cognitive decline.”
• “Vinpocetine … is very popular in Eastern Europe as a treatment for cognitive decline and is under study to help with Parkinson’s and Alzheimer’s.  . . . [I]t also shows great promise as an anti-inflammatory agent.”
• “Choline is now being used to treat Alzheimer’s” [Choline is an ingredient in your Liva-Vite]
• “Willard’s Water is also known for reducing inflammation .. one of the most common user reports we get is from arthritis sufferers telling us how much improvement they’ve seen in their stiff and swollen joints”
• “Vitamin B1 (thiamine): has been used to help with the symptoms of Alzheimer’s Disease.”
• “Vitamin B2 (riboflavin): has been used for the preventative treatment of migraines.”
• “Vitamin B5 (Pantothenic Acid): has been used to reduce levels of cholesterol in mice.”
• “Vitamin B7 (Biotin): has shown promise in helping regulate blood sugar in diabetics, particularly in reducing fast-ing glucose levels”
• “Vitamin B12: another vitamin that has shown promise in preventing cognitive decline, but interestingly, is also used to treat cyanide poisoning.”
• “Vitamin C: is itself an antihistamine … this should reduce allergic reactions”

On your Sept/Oct 2013 “Possibilities” newsletter titled, “What Benefits Pre-Diabetics, Cancer, Alzheimer’s, Psoriasis, Kidneys, Viral & Bacterial Infections, Plus It’s An Antioxidant, An Anti-Arthritic and Has Anti-Inflammatory Properties?” [bold font in original]

• “A recent study published in Diabetes Care (the official Journal of the American Diabetes Association) examined treating pre-diabetic patients with Curcumin . . . could help prevent pre-diabetics from developing actual Type 2 Diabetes. . . . [N]ot one of the patients given Curcumin extract (250 mg three times a day) developed Type 2 Diabetes in the course of the study” (bold font in original)
• “Curcumin is also said to have possible benefits for a myriad of other conditions such as: Cancer (several forms of it), Alzheimer’s Disease, Psoriasis, Kidney Disorders, [and] Protection from Viral & Bacterial Infections”
• “WW’s (Willard’s Water) other characteristics … include: … Having Anti-Inflammatory properties and reducing swelling … Helping the healing of various skin problems (… psoriasis … “

On your Sept/Oct 2014 “Possibilities” newsletter titled, “Raises Dementia or Alzheimer’s Risk 53% - 125%” [bold font in original]

• “those who were moderately deficient in this nutrient, had a 53% increased risk of developing any kind of dementia, and those participants who were severely deficient had their risk of developing any kind of dementia increase by 125%. Results for the impact of this nutrient on the development of Alzheimer’s disease were similar. People with moderate deficiencies had an increased risk of 69% of developing Alzheimer’s, and those with a severe deficiency had their risk of developing Alzheimer’s increase by 122%. What’s the nutrient? … Vitamin D.”
• “Vitamin D ... may also … possibly reduce Breast Cancer risk by 90%[,] possibly Double the chance of surviving breast cancer[,] decrease risk of ALL cancers by 77% at just moderate levels of Vitamin D[,] lower LDL Cholesterol[,] help prevent Autism . . ..” (bold font in original)
• “Vitamin D has also been found to: reduce the risk of preterm birth by Half, as well as to lower the risk of having a low birth weight baby and lower the risks of having a C-section.”
• “This product has been said to help people get over or avoid colds, the flu, and nearly any bacterial or viral infection … We’re talking about Colloidal Silver.”
• “‘Silver solutions are applied to new-born babies’ eyes to prevent common eye infections after birth … (silver) fights germs with much less fear of developing anti-biotic resistance … silver was effective against over 600 disease organisms, including viral infections.”
• “Ultimate Willard’s Water Lotion with Goat’s Milk … anti-inflammatory properties: GOAT’S MILK REDUCES SKIN INFLAMMATION … anti-bacterial properties that delay the growth of microbial organisms”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Alpha-Lipoid Acid, Colostrum Alpha Whey III (Liquid), CoQ10, Curcumin, Liva-Vite, Milk Thistle, Selenium, Vinpocetine, Vitamin B Complex, Vitamin D3, and Vitamin E are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Alpha-Lipoid Acid, Colostrum Alpha Whey III (Liquid), Colloidal Silver, CoQ10, Curcumin, Echinacea Root, Liva-Vite, Milk Thistle, Selenium, Vinpocetine, Vitamin B Complex, Vitamin D3, and Vitamin E fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease (e.g., your Colloidal Silver) is regarded as a “new drug” within the meaning of section 201(p) of the Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. § 352].

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.

Sincerely,

/S/

William A. Correll Jr.

Director

Office of Compliance

Center for Food Safety and Applied Nutrition