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October 16, 2020

In reply, refer to CMS 610053
 

WARNING LETTER

Dear Mr. Gates:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.immusist.com in August and October 2020, and has determined that you take orders there for the products IMMUSIST Original and IMMUSIST Natural. The claims on your website 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.

An example of the website claims that provide evidence that your products are intended for use as drugs include the following:

• “IMMUSIST™ . . . was formulated by blending certain surfactants with characteristics such as Antivirals, Antifungals . . . and Antibacterials that can . . . reduce inflammation . . .”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of IMMUSIST Original and IMMUSIST Natural products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials on the Life Experiences webpage on www.immusist.com include:

Under the heading Acid Reflex [sic]/Heartburn:

• “Being diagnosed with acid reflex [sic], nights are the worse [sic] . . . With Immusist I’ve had less and less reflexes [sic] at night.”
• “Then I found Immusist; it calmed the acid and took my heartburn away without the bad side effects.”

Under the heading Cancer:

• “I was diagnosed with Ovarian Cancer and went through chemo and radiation which depleted my immune system and left me tired with sore joints and muscles. I started taking Immusist. Within days . . . my joints and muscles were not even sore.”
• “I have Breast Cancer and have under gone several chemo treatments. My immune system is weakened and I have gotten colds and mouth sores . . . I have not had a cold and I have been putting Immusist right on the mouth sores and they are clearing up. Immusist really works!”

Under the heading Diabetes:

• “Living with diabetes for several years, I would get open sores that take forever to heal . . . I started taking Immusist 3 times a day, plus I . . . started spraying my feet, leg and arm . . . After about two weeks the sores were all healed up! . . . I test my blood sugar several times a day, and the numbers started to lower and my insulin intake was much less. Not only did Immusist work but it was fast!”
• “A toe was removed due to my diabetes . . . if the rest of my foot didn’t start healing I might have to have it removed too . . . Immusist saved my foot. With Immusist my diabetes is more manageable now.”
• “I was hospitalized with onset diabetes, high blood pressure and a blood infection . . . I went from not having to take medication to a life changing 10 pills a day! . . . It’s been a few months now with Immusist and I am down to just 3 pills a day. My tests continue to show progress . . .”
• “Before taking Immusist I was on the verge of having to take insulin for diabetes. After taking Immusist . . . I did not have to take insulin. My cholesterol even dropped 50 points.”

Under the heading Feet:

• “I put a drop of Immusist on my ingrown toe nail and carefully rubbed it in. This helped to reduce the pain . . . After the cut nail was removed I was hit with severe pain. I put one more drop on the toe and let it seep right into the sore spot. Immediately my pain was reduced and infection didn’t set in, like so many times before. The next day I could walk with no pain . . .”
• “I stubbed my toe severely causing my toe nail to fall completely off. The pain was unbearable. I put a few drops of immusist right on it and the pain relief was amazing! I continued to put a few drops on daily . . . After about 4 or 5 days I was able to walk without pain. I never got an infection and the nail quickly grew back.”
• “I peeled off my shoes . . . to find huge blisters. Some of them had burst open and were seeping and very painful . . . I remembered reading Immusist was antibacterial so I put drops on all the blisters . . . My blisters healed in no time due to Immusist.”

Under the heading Lupus:

• “I have lupus and every day tasks are draining and painful to my body . . . A friend recommended Immusist and I started taking it . . . tasks that were painful before are not any more!”

Under the heading Migraines:

• “I now take Immusist daily and it has reduced the frequency and intensity of my migraines. Immusist really works and it does not have any side effects like other treatments I have taken in the past.”
• “I’m a migraine and headache sufferer . . . I started taking Immusist daily, in the beginning if I felt any pain coming on, I would take an extra dose right away, it really helped take the pain away and I didn’t have any adverse side effects.”
• “I have taken Immusist regularly and have found that it does not affect my asthma and it helps take my headaches away.”
• “I suffered with debilitating migraine headaches for the last 40 years. Guess what? I have not had a migraine headache since I have been on Immusist.”

Under the heading Mouth:

• “If you have ever had a cold sore . . . I usually have the sore for about three weeks but with Immusist it was like less than 2.”
• “My gums kept getting infected and . . . the report showed surface cancer. My mother suggested that I take Immusist . . . my gums had returned to normal with no complications or in need of further treatment.”

Under the heading Multiple Sclerosis:

• “The MS accelerated to the point that I could no longer work . . . As a RN I probably would not have tried Immusist, but I was desperate. Sure glad I did. I’m back to work full time with energy & no pain.”

Under the heading Psoriasis:

• “I have plaque psoriasis . . . I also have psoriasis arthritis . . . My doctor suggested I try Immusist . . . He explained . . . it would help with my inflamed joints and skin . . . I have now been taking IMMUSIST for a little over 2 months . . . My skin has almost cleared up . . . My arthritis is barely noticeable to me now.”
• “For years I have been battling psoriasis . . . I kept seeing more and more of people’s experiences with Immusist on the forum . . . The first time taking it was OMG this doesn’t taste very good! . . . From the forums I read about also putting it in a spray bottle and spraying it on my skin. You know that was the best advice I have ever gotten about psoriasis care! The pain redness and itchiness was incredibly reduced! My overall health started to improve along with my skin.”
• “[S]he recommend [sic] that I try Immusist on my psoriasis . . . When I sprayed Immusist on the skin . . . I have able to reduce the number of patches on my skin significantly. My fungal infection healed up within a few days.”

Under the heading Rheumatoid Arthritis:

• “Rheumatoid Arthritis was taking away my mobility, just getting out of bed was very painful . . . Immusist has made it possible to enjoy life more . . .”

The above noted website claims are supplemented by a metatag used to bring consumers to your website through Internet searches. The metatag is:

• “IMMUSIST Assists immune systems for . . . pain relief.”

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 IMMUSIST Original and IMMUSIST Natural 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, IMMUSIST Original and IMMUSIST Natural 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 statement 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 (15) 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 (15) 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 written reply should be sent to the Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021, to the attention of Tracy K. Li, Compliance Officer. If you have any questions, please contact Compliance Officer Li at (425) 302-0428.

Sincerely,
/S/

Miriam R. Burbach
District Director
Program Division Director