Phoenix Nutritionals, Inc.
FDA issued a warning letter to Phoenix Nutritionals, Inc. (President Kaleo Steven Whiting) regarding eight dietary supplement products marketed on phoenixvitamins.com, healthyinformation.com, and Facebook. The agency found that disease-treatment claims on the websites — including claims related to cancer, diabetes, heart disease, arthritis, COVID-19, and other conditions — caused the products to be classified as unapproved new drugs under the FD&C Act. The products were also deemed misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (21)
Lower cholesterol naturally and avoid the many side effects possible with statin drugs.
Selenium [an ingredient in your High Vitality products] has anti-cancer factors as well. Studies have shown that proper dosages of Selenium can reduce Lung Cancer by as much as 46 percent, Esophageal Cancers by 67 percent, Colon Cancer by 62 percent and last yet most impressive, Prostate Cancer by 72 percent.
One study showed that when potential heart transplant patients were given sufficient Co-Q10 [an ingredient in your High Vitality products], they no longer needed the surgery!
Anti-anxiety and Anti-depressant Drugs ...We take Xanax and Wellbutrin as examples, to manage anxiety and depression…What we need to keep in mind of course is that Xanax, Wellbutrin, and other drugs in these categories provide their benefit not without side effects. In addition to the potential side effects, most of these drugs are highly habit forming and can be very difficult to stop. With our natural vitamins for stress formula there are no side effects whatsoever.
A new study has shown that the B complex vitamins may be able to reduce the severity of the effect of this virus on those who are at higher risk....By using a full-spectrum multivitamin mineral supplement, together with a targeted broad spectrum immune support formula, you can add an extra level of protection so that your body can better protect you.
…type II diabetes is almost always controllable and even preventable through…most importantly, key diabetes supplements. There are many potential complications of diabetes, including neuropathy, amputations, increased cardiovascular risks, kidney damage, elevated cholesterol, and heart attacks…. Because of these complications, seeking diabetes treatment and controlling blood sugar levels has become popular. Both diet and supplements are involved in discussing how to reverse diabetes. . . .
Turmeric [an ingredient in your Natural Anti-Inflammatory Support product] or the active agent it contains called Curcumin, has shown to be as powerful as over-the-counter pain killers so many are addicted to. The best anti-inflammatory supplement would certainly contain this ingredient.
…Lycopene [an ingredient in your High Vitality Full Spectrum Liquid Multi-Vitamin] is ten times more powerful in protecting against Cancer!
Blood Sugar Support Aggressive Support for Obesity
Immune support supplements are very important during outbreaks such as we are currently experiencing. We have developed a natural immune booster support formula, which we have been using for several years with excellent results.
Very recent studies over the last two years have indicated that Co-Q10 [an ingredient in your High Vitality products] can help slow the progression of Parkinson's disease.
Further, it helps reduce the auto-immune response, in Rheumatoid Arthritis, which causes the body to attack and destroy its own joints and connective tissues. In fact, CMO [an ingredient you claim is in your Complete Joint Support product] has demonstrated such an autoimmune suppression that it is now being used in other autoimmune disorders such as Lupus and Crohn's disease.
The next few months will be among the highest for cases of Covid-19 as the next wave of the virus spreads across the country. We can already see this taking place in Europe and in parts of the U.S. For this reason, we wanted to let you know that we are advising everyone to take our Immune Support Formula at least through the end of January.
Since Glucosamine Sulfate [an ingredient in your Complete Joint Support product] not only starts the production of the key elements of joint and cartilage integrity, but also protects the existing cartilage, it can actually help the body repair and replace lost cartilage, thereby reversing the disease process!
'I was shocked to find out from my doctor that my blood sugar was so high. He said that I was I [sic] the early stages of diabetes. I contacted your Center and with your diet recommendations and your wonderful Blood Sugar Support supplement, my blood sugar levels are in the normal range again.'... DIABETES SUPPORT AND CONTROL . . .
So powerful is Milk Thistle [an ingredient in your High Vitality products], which in one study it cut the death rate from Cirrhosis by a full 50 percent. Anyone suffering from any form of Hepatitis MUST consider Milk Thistle as part of their treatment and management program.
This formula, along with Full Spectrum Nutrition, has helped tens of thousands of people live a normal life, free from Hypoglycemia and Diabetes. Together with the proper diet as outlined earlier, it can ensure that you will not have to progress to further stages of these diseases.
CoQ10 [an ingredient in your High Vitality products] actually reduces angina . . .
'My arthritis has been getting slowly worse over the years. The stiffness and swelling of the joints in my knees and elbows was really getting bad. I started on your arthritis formulas 4 months ago and now I'm doing so much better. That Natural Anti-Inflammatory Support product you developed has helped to reduce the inflammation significantly.' REDUCE INFLAMMATION SIGNIFICANTLY...
Lutein [an ingredient in your High Vitality Full Spectrum Liquid Multi-Vitamin] was shown to almost completely prevent this Free Radical Activity from invading the cells of the Macula, thereby controlling and preventing Macular Degeneration.
Other types of cancer that may be prevented through the presence of Lycopene [an ingredient in your High Vitality Full Spectrum Liquid Multi-Vitamin] in adequate amounts include breast, lung and endometrial…. Other benefits from Lycopene include prevention of heart disease.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so.
We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
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