WARNING LETTER
Phoenix Nutritionals, Inc.
MARCS-CMS 613909 —
July 01, 2021
Delivery Method:
Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Mr. Kaleo Steven Whiting
Recipient Title
President
Phoenix Nutritionals, Inc.
4727 Terrace Drive
San Diego
,
CA
92116-2515
United States
Issuing Office:
Office of Human and Animal Food Operations-West Division 5
United States
WARNING LETTER
July 1, 2021
WL # 613909
Dear Mr. Whiting:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://phoenixvitamins.com in June 2021, and has determined that you take orders there for your products High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support. We also reviewed your website https://healthyinformation.com and your social media website https://facebook.com/phoenixnutritionalsinc/, where you direct consumers to your website https://phoenixvitamins.com to purchase your products. In addition, we observed that the product Best Immune Support is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
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in people. The claims on your websites establish that the products High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support 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 website claims that provide evidence that your products are intended for use as drugs include:
1) High Vitality FULL SPECTRUM Liquid Multi-Vitamin and High Vitality Caps (collectively, the “High Vitality products”)
On your website https://healthyinformation.com:
From your “Special Report” titled, “Antioxidants & Free Radical Damage,” which includes “SHOP NOW” buttons that link to the High Vitality Full Spectrum Liquid Multi-Vitamin and the High Vitality Caps product pages of your website https://phoenixvitamins.com:
- “…Vitamin A [an ingredient in your High Vitality products] is vital in all disorders of both chronic and acute intestinal inflammations. There is some evidence that Vitamin A exercises anti-cancer effects as well. This would be especially true for those areas where mucous membrane tissue may be found. One study involving over 300 people who underwent surgery for Lung Cancer, found that the group who took very high amounts of Vitamin A had far fewer new tumors than people who did not use the vitamin.”
- “Other specific sites within the body, which are protected by Vitamin C [an ingredient in your High Vitality products] include the Pancreas, the Lungs and the Prostate Gland, preventing cross linkage of these tissues. This greatly reduces the risk of Cancer in these sites.”
- “Further, Vitamin E [an ingredient in your High Vitality products] actually helps to lower overall Cholesterol and Triglycerides in the bloodstream. Vitamin E is a natural blood thinner and helps to prevent fats, naturally occurring in the blood, from sticking together. Other areas where Vitamin E performs antioxidant and healing effects include some forms of Cancer, Neurological disorders, Lung diseases...”
- “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.”
- “Zinc [an ingredient in your High Vitality products] is also vital to Diabetics, especially the Type I, Juvenile Onset, because Zinc is a primary constituent of the hormone Insulin, and since they produce very little Insulin, Zinc can frequently enhance this production.”
- “…Lycopene [an ingredient in your High Vitality Full Spectrum Liquid Multi-Vitamin] is ten times more powerful in protecting against Cancer!”
- “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.”
- “Studies conducted in Italy have shown that Bilberry [an ingredient in your High Vitality products] can improve circulation to the eyes thereby mitigating such conditions as diabetes-caused glaucoma, day blindness, nearsightedness, and cataract formation.”
- “Bilberry [an ingredient in your High Vitality products] is also very useful in such conditions as leg swelling, varicose veins…. Lastly, Bilberry helps diminish inflammation, a helpful effect in such conditions as Arthritis and other inflammatory disorders…it is very good for wound healing. Wounds heal faster and with less infection.”
- “ Some of the specific benefits, which may be derived from grape seed extract [an ingredient in your High Vitality products], include…*Assists in the prevention of Histamine formation, an important factor for allergy sufferers. * Grape Seed extract protects us against radiation from all sources…”
- “Some of the specific areas where Co-Q10 [an ingredient in your High Vitality products] has proven helpful include in chronic conditions such as Heart Disease, Diabetes, High Blood Pressure, Obesity and even Cancer.”
- “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!”
- “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.”
- “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.”
- “Among the many direct benefits of ALA [an ingredient in your High Vitality Full Spectrum Liquid Multi-Vitamin], one of the most important is its ability to protect the body against the ravages of excess insulin as found in all Hyperinsulinemia conditions, which include most Obesity, …Hypoglycemia and of course, Type II Diabetes.”
- “ALA [an ingredient in your High Vitality Full Spectrum Liquid Multi-Vitamin] can help to reduce and regulate Cholesterol levels, exercising a lowering effect on Cholesterol by as much as 40 percent.”
- “Other important functions of ALA [an ingredient in your High Vitality Full Spectrum Liquid Multi-Vitamin] include protecting the body against specific types of Cancers ...”
- “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.”
From your “Special Report” titled, “Preventing & Reversing Heart Disease”:
- “CoQ10 [an ingredient in your High Vitality products] actually reduces angina . . .”
2) Best Cholesterol Support
On the Best Cholesterol Support product page of your website https://phoenixvitamins.com:
- “Regardless of your viewpoint on the subject, it is generally agreed that excess cholesterol in the blood is not a healthy situation. Cholesterol lowering foods really make very little impact on your overall cholesterol levels. Our Best Cholesterol Support is one of the most complete supplements, providing all the known factors that can help support lower cholesterol.”
- “The body can effectively use these cholesterol lowering supplements to regulate cholesterol…”
- “Lower cholesterol naturally and avoid the many side effects possible with statin drugs.”
3) Blood Sugar Support
On the Blood Sugar Support product page of your website https://phoenixvitamins.com:
- “Blood Sugar Support Aggressive Support for Obesity”
- “… Helps to stabilize Blood Sugar, Key to Stabilizing Blood Sugars controlling Insulin Levels…”
On your Facebook Page at https://facebook.com/phoenixnutritionalsinc/, from a Facebook post, dated 9/23/2020:
- “Blood Sugar Support Aggressive Obesity Support for Obesity”
- “…helps stabilize blood sugar key to stabilize blood sugars to control insulin levels…”
- “…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. . . . [hyperlink to the Blood Sugar Support product page of your website https://phoenixvitamins.com].”
On your website https://healthyinformation.com:
From your “Special Report” titled, “Managing Diabetes & Hypoglycemia,” which includes a “SHOP NOW” button that links to the Blood Sugar Support product page of your website https://phoenixvitamins.com:
- “In addition to Chromium, the mineral Vanadium [ingredients in your Blood Sugar Support product] . . . have been shown to be very helpful in assisting the body in the regulation of glucose and insulin. Following are the ratios of these nutrients which we have used with tremendous success at The Institute. 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. Further, you will not have to suffer the numerous and debilitating side effects which arise from excess insulin in the blood. Components of a Comprehensive Glucose/Insulin Regulating Formula: Chromium . . . Vanadium . . . Alpha Lipoic Acid . . . Cinnamon . . . Bitter Melon . . . Gymnma [sic] Sylvestre . . . [ingredients in your Blood Sugar Support product]”
From your blog post from 6/15/2020, titled “Best Supplement to Stabilize Blood Sugar”:
- “Excess silent inflammation inside the body has been linked to not only type II diabetes but heart disease and arthritis as well. In fact, most chronic degenerative diseases can find their origin in excess uncontrolled inflammation. Nutrients such as chromium, vanadium, aspartic acid, and cinnamon extract, to name a few have shown promise in … modulating insulin production, thereby reducing the potential harm from insulin’s pro-inflammatory nature. We have used our specialized blood sugar formula with tremendous success with thousands of clients over the years.” [the phrases “Nutrients such as chromium, vanadium, aspartic acid, and cinnamon extract” and “blood sugar formula” link to the Blood Sugar Support product page of your website https://phoenixvitamins.com.]
Your website https://healthyinformation.com also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Blood Sugar Support for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
- “‘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 . . .”
4) Maximum Stress Support
On the Maximum Stress Support product page of your website https://phoenixvitamins.com:
- “While B-complex vitamins are at the heart of this formula, there are also several other supportive co-factors included, making this one of the best anxiety support supplements available.”
- “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.”
On your website https://healthyinformation.com, from your “Special Report” titled, “Managing Stress Naturally,” which includes a “SHOP NOW” button that links to the Maximum Stress Support product page of your website https://phoenixvitamins.com:
- “Nutrients for Stress Support Vitamin C . . . Vitamin B-1 . . . Vitamin B-2 . . . Vitamin B-6 . . . Vitamin B-1 [sic] . . . Pantothenic Acid . . . Calcium . . . Magnesium . . . and Valerian Root Extract [ingredients in your Maximum Stress Support product]... if you suffer from anxiety, you should double the above doses. You can stay at that level of supplementation for four to eight weeks if needed. Additional nutrient support for anxiety or severe prolonged stress follows... Each of the formulas and protocols detailed in this Special Report are available exclusively from Phoenix Nutritionals…”
5) Complete Joint Support
On the Complete Joint Support product page of your website https://phoenixvitamins.com:
- “Provides the nutrients for Rebuilding Cartilage.… Arthritis occurs when cartilage tissue, the soft spongy substance within joints, wears down faster than it can be replaced.”
On your website https://healthyinformation.com:
From your “Special Report” titled, “Preventing & Reversing Arthritis,” which includes a “SHOP NOW” button that links to the Complete Joint Support product page of your website https://phoenixvitamins.com:
- “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!”
- “Methyl-Sulfonyl-Methane (MSM) [an ingredient in your Complete Joint Support product]… MSM is an important adjunct to an overall Arthritis support program due to the fact that it relieves both pain and inflammation.”
- “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.”
6) Natural Anti-Inflammatory Support
On the Natural Anti-Inflammatory Support product page of your website https://phoenixvitamins.com:
- Your product name: “…Anti-Inflammatory Support”
- “…Nutritional Support for Aches, Pains, Joint Discomfort, and Sports Injury caused by Inflammation. The Best Anti-Inflammatory Supplement…”
- “We now know that conditions such as diabetes, heart disease, Alzheimer’s, and even obesity are all linked to what is called silent inflammation…. By using supplements, we can help the body.”
- Your Supplement Facts label says the product contains “A Proprietary Blend of InflamEZe”
- “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.”
On your website https://healthyinformation.com:
From your “Special Report” titled, “Preventing & Reversing Arthritis,” which includes a “SHOP NOW” button that links to the Natural Anti-Inflammatory Support product page of your website https://phoenixvitamins.com:
- “Boswellia Extract [an ingredient in your Natural Anti-Inflammatory Support product] Boswellia, the botanical name for a small family of trees, has been used for ages in the treatment of aches and pains.... Boswellic acid extracts have demonstrated anti-arthritic effects in a variety of animal models.”
Your website https://healthyinformation.com also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your Natural Anti-Inflammatory Support for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
- “‘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...”
7) Best Immune Support
From the Best Immune Support product page of your website https://phoenixvitamins.com:
- “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.”
- “If you get more than one cold or the flu annually, it may be a sign that you are in need of immune boosters. Vitamins to boost your immune system can be found in The Institute’s Targeted formula called Best Immune Support. Best Immune Support provides all the known immune booster supplements for protecting the immune system naturally.”
From your blog post from 9/28/2020, titled “Immune Support During Reopening,” at: https://healthyinformation.com/immune-support-during-reopening/:
- “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.” [The phrases “full-spectrum multivitamin mineral supplement” and “targeted broad spectrum immune support” link to the Best Immune Support product page of your website https://phoenixvitamins.com. Below this claim is an audio file titled, “Your Immunity During These Times of Corona Virus.”]
On your Facebook Page at https://facebook.com/phoenixnutritionalsinc/, from a Facebook post, dated 11/5/2020:
- “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. We have just received a fresh supply of this powerful formula and it’s ready for immediate shipment. Order online at: https://phoenixvitamins.com/product/best-immune-support/”
Your High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, 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 High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support products 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, High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support products 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Sergio Chavez, Director Compliance Branch, 19701 Fairchild, Irvine, CA 92612. Refer to Unique Identification Number CMS # 613909 when replying. If you have any questions regarding this letter, please contact Sara J. Dent Acosta, Compliance Officer, at sara.dent@fda.hhs.gov or (619) 941-3767.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations-West Division 5
cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435
___________________________________
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There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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.
Content current as of:
07/13/2021
Regulated Product(s)
Drugs
Food & Beverages