WARNING LETTER
Nutritional Supplements Corporation Inc
MARCS-CMS 608903 —
August 25, 2020
Delivery Method:
Via Overnight Delivery
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Mr. A.T. Scott
Recipient Title
President
Nutritional Supplements Corporation Inc
3325 Crossings Court
Birmingham
,
AL
35242
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
August 25, 2020
RE: 608903
Dear Mr. Scott
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.nutritionalsupplementscorp.com in June 2020 and has determined that you market and take orders for the products Vitadone,” “Diabrex,” and “Viadevita” from the web links on your website that direct your customers to your Amazon product pages to purchase the aforementioned products. The claims on your website and Amazon product pages establish that the 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 for such uses 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 website, your product labels, and Amazon product pages that provide evidence that your products are intended for use as drugs include:
Vitadone
On the product page for “Vitadone” on www.nutritionalsupplementscorp.com:
“A nutritional supplement formulated especially for methadone patients.”
“With its aggressive formulation of vital nutrients and vitamins, Vitadone effectively addresses such real world issues as bowel irregularity related to the use of Methadone. Vitadone has no Iron and thus is also appropriate for people with Hepatitis C.”
“Special dosage: two tablets with breakfast and two tablets with lunch to relieve bowel irregularity.”
On your Amazon product page for “Vitadone”:
“Vitadone, Multivitamin for Methadone Patients | Fights Fatigue, Promotes Regularity, and Helps Reduce Sugar Cravings”
“ASSISTS OPIOID ADDICTION RECOVERY: Many opioids can cause addictions. Such as heroin, hydrocodone, codeine, oxycodone, and other narcotic pain killers. Such addictions can be accompanied by side effects such as bowel irregularity, severe cramping, loss of appetite, sugar cravings, sweating, and others. Vitadone is designed to “break the blood barrier” exposing body organs to the array of vitamins and minerals, thus, enhancing normal body functions and providing energy and stamina.”
“USE WITH METHADONE TREATMENTS: Vitadone is used by people who are on a methadone treatment program. Vitadone was created specifically for opiate addicted patients on methadone. It addresses side effects from the treatment of methadone like the regularity of bowel movements, sweating, sugar cravings, and fatigue.”
“OTHER USES FOR MEN & WOMEN: While Vitadone was formulated to specifically combat the effects of methadone treatment, that’s not its only use … Vitadone can also be used by people with Hepatitis C.”
“Vitadone is commonly used by people who are on a methadone treatment program. Vitadone was created specifically for opiate addicted patients on methadone. It addresses the negative side effects associated with methadone.”
Diabrex
On the product page for “Diabrex” on www.nutritionalsupplementscorp.com:
“Diabrex is a chelated nutritional supplement to assist everyone, including those with diabetes”
“In addition, such nutrients increase the health of a patient to which they are administered. Thus, the nutrient composition and any standard drug treatment act synergistically to increase the quality of life, and life expectancy of a patient. In a related aspect, the invention features a similar method for treatment of disorders caused by diabetes by administration of a composition as described above.”
Viadevita
On the product page for “Viadevita” on www.nutritionalsupplementscorp.com:
“For individuals with HIV/AIDS, good nutrition is essential to support overall health and strengthen the immune system. Viadevita is specially formulated to provide this vital nutritional support. In addition, this patented formula can help support the effectiveness of the antiviral and other drugs while its immune boosting nutrients help protect naturally from the toxic effects of the antiviral medications. This nutritional support, when combined with standard HIV/AIDS drug treatment, can improve the quality of life and maximize opportunity to extend life expectancy.”
“Viadevita is specially formulated to support the overall health and immune systems of individuals with HIV/AIDS … It can also support the effectiveness of antiviral drugs while simultaneously helping to protect naturally from the toxic effects of some medications.”
On your Amazon product page for “Viadevita”:
“WHAT IS HIV AND AIDS? HIV is a virus that attacks the immune system and can destroy it if left untreated. AIDS refers to a set of symptoms that occur in the final stages of an HIV infection. While there is now no known cure for HIV, proper nutritional support may help keep you healthier longer. Viadevita is a natural immune support formula that can promote a healthy immune system.”
“IMMUNE SYSTEM SUPPORT SUPPLEMENT: Autoimmune diseases like HIV and AIDS often leave people feeling sick and make them more susceptible to infections and diseases. Viadevita is designed to be an immune system booster. This cellular support supplement is ideal for men and women alike. Support your immune system health with Viadevita.”
Your website at www.nutritionalsupplementscorp.com also contains evidence of intended use in the form of personal testimonials recommending or describing the use of "Vitadone" for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
“I recently started taking methadone to combat and control a nasty addiction habit. The nurse at the clinic suggested I take Vitadone. What a huge difference! The sugar cravings have decreased. I am eating and sleeping better, but best of all the bowel regularity is coming back.”
“I have been on methadone for six horrible years. The side effects are just pathetic. I have a wife and three kids. I work six days a week. As soon as I get home I don’t want to do nothing besides go to bed. I am tired all day long and don’t want to go anywhere. I noticed a flier in my counselor’s office for Vitadone. I heard good things about it, and looked it up on line and bought a bottle. I got it 2 days later. I took it as prescribed , 3 a day, morning, lunch, and dinner. On Sunday I actually felt refreshed and awake and I was in a pretty good mood. I have not had so much energy since I was fifteen years old. I am writing to see if you would contact my clinic. They do not sell it. If they did it would help so many more people like it did me. It gave me back my life.”
“One of the most satisfying benefits is the relief of constipation. Thank you for introducing Vitadone.”
“I have been on methadone for one year. A few months ago I tried Vitadone and within a couple of weeks I noticed my constipation had eased considerably. Prior to taking Vitadone I would wake up at night with my sheets and clothes soaked with sweat. Since using Vitadone, I no longer have this problem! What a difference. I stand on my feet most all day with my job. Since using Vitadone my stamina has increased tremendously.”
“I am writing to let you know how much Vitadone has worked for me. It helps me with my side effects. It helps keep me from falling asleep, and also helps enhance the meds I’m on.”
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 CFR 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 “Vitadone,” “Diabrex,” and “Viadevita” 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, “Vitadone,” “Diabrex,” and “Viadevita” 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)].
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 legal 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 cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your response should be sent by email to Mr. Shawn Goldman at FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
09/08/2020
Regulated Product(s)
Dietary Supplements
Food & Beverages