WARNING LETTER

World Nutrition, Inc. MARCS-CMS 610003 — October 27, 2020

Delivery Method:: VIA UPS
Product:: Drugs
Food & Beverages

Recipient:: Recipient Name

Ryuji Hirooka; Recipient Title

President and Director; World Nutrition, Inc.; 9449 N 90th Street Ste #116
Scottsdale, AZ 85258-5063
United States

Issuing Office:: Division of Human and Animal Food Operations West IV; United States

October 27, 2020

WARNING LETTER

Ref: CMS Case #610003

Dear Mr. Hirooka:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.worldnutrition.net in September 2020 and has determined that you take orders from your website for the following products: Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, Nättovīta™, Ketsumeisei™, Probiotic 10/50 by Vitälzȳm, Flexera™, and PuraCell™. 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 through links on FDA’s home page at www.fda.gov.

Examples of claims observed on your website that provide evidence of the intended use of your products as drugs include:

Vitälzȳm Extra Strength product page
• “[R]educe chronic inflammation, regulate an over-active or weakened immune system, remove excess fibrin and plaque that may have been building for years, and restore healthy blood flow.”
• “Bromelain [an ingredient in Vitälzȳm Extra Strength] – . . . has anti-inflammatory properties.”
• “Rutin [an ingredient in Vitälzȳm Extra Strength] – . . . function as anti-inflammatory, antihistaminic, and antiviral agents.”

Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula) product page
• “Serrapeptase, the primary systemic enzyme ingredient [in the product], is . . . known for its ability to control inflammation, regulate the immune system, remove excess plaque and fibrous tissues . . .”
• “Bromelain [an ingredient in Vitälzȳm Systemic and Digestive Formula] – . . . has anti-inflammatory properties.”
• “Rutin [an ingredient in Vitälzȳm Systemic and Digestive Formula] – . . . function as anti-inflammatory, antihistaminic, and antiviral agents.”

Vitälzȳm Cardio product page
• “Recent studies have shown the correlation between elevated vascular inflammation and heart disease. C-Reactive Protein levels are used as a marker for vascular inflammation. The enzymes in Vitalzym Cardio have been shown to reduce the levels of C-Reactive Protein.”
• “Reduces Fibrin in The Blood: The fibrinolytic enzymes in Vitalzym Cardio, particularly Nattokinase, have been shown to have the ability to digest excess fibrin (protein buildup) in the blood, allowing for improved blood viscosity. It may also help dissolve existing blood clots (thrombus) by dissolving the fibrin that binds platelets and red blood cells together.”
• “Nattokinase [an ingredient in Vitälzȳm Cardio] – helps support natural blood thinning to protect against blood-clotting ailments.”

Vitälzȳm Digest product page
• “Combat chronic inflammation”
• “Neutralize rogue proteins in the blood than can trigger a hyper-autoimmune response”
• “Break down excess fibrin that contributes to scar tissue and fibrosis”
• “Reduce build-up in the arteries thus improving blood flow and circulation”
• “Bromelain [an ingredient in Vitälzȳm Digest] . . . may be used as an anti-inflammatory . . .”

Vitälzȳm Xe product page
• “Studies show that Serrapeptase [an ingredient in Vitälzȳm Xe] induces fibrinolytic, anti-inflammatory and anti-edemic (preventing swelling and fluid retention) activity in a number of tissues. Its anti-inflammatory effects are widely believed superior to other proteolytic enzymes. Another primary benefit of Serrapeptase is the reduction of pain; particularly in the enzyme’s ability to block the release of pain-inducing amines from inflamed tissues. Physicians in Europe and Asia use Serrapeptase in treatment as an alternative to aspirin, ibuprofen, and other NSAIDS.”
• “Bromelain [an ingredient in Vitälzȳm Xe]: . . . has demonstrated anti-inflammatory properties.”
• “Rutin [an ingredient in Vitälzȳm Xe]: One of the many existing flavonoids.. . . some [flavonoids] function as anti-inflammatory, antihistaminic, and antiviral agents.”

Nättovīta™ product page
• “This proprietary blend combines the power of nattokinase with vitamin K2, CoQ10, and B vitamins necessary for managing inflammation . . ..”
• “Reduced vascular inflammation”

Ketsumeisei™ product pages
• “Originally created to combat the negative effects of blood sugar imbalances . . . shown to be effective in supporting . . . microcirculatory disorders within the body.”
• “May improve fatty liver condition”
• “Ketsumeisei . . . is a proprietary blend of premium Chinese herbs known for their support of healthy circulatory and metabolic functions related to the liver. Restoring liver function and systemic microcirculation helps support numerous processes throughout the body which may improve:
o Blood sugar control
o Fatty[] liver”
• “Dr. Xianen Wang began investigating viable diabetes treatments when he noticed that the disease was on the rise with increasing numbers of patients suffering and dying from complications. The development of insulin and medications did not lower the incidence. Because genetic and molecular therapies provide only local treatment for certain symptoms, Dr. Wang formulated Ketsumeisei, a proprietary herbal compound that has been widely used in China and Japan to treat diabetes for many years.”

Probiotic 10/50 by Vitälzȳm product pages
• “Lower Cholesterol Levels”
• “Regulate Diarrhea”
• “Inhibit Growth of Pathogenic Organisms”
• “Prevent Reproductive Tract Infection”
• “Salivarius (Ls-33) [an ingredient in Probiotic 10/50] - Improve allergic constitution by stimulating immune system, causing Th1 immune response to neutralize the Th2 immune response that [sic] caused by allergy.”
• “Casei (Lc-11) [an ingredient in Probiotic 10/50] - . . . may be effective in alleviation of gastrointestinal pathogenic bacterial diseases.”
• “Rhamnosus (Lr-32) [an ingredient in Probiotic 10/50] - . . . prevent and treat diarrhea; eliminate allergy and also has bacteriostatic function.”
• “Breve (Bb-03) [an ingredient in Probiotic 10/50] - . . . inhibit the growing of harmful bacteria like Escherichia coli.”
• “Longum (BI-05) [an ingredient in Probiotic 10/50] - . . . prevent growth of pathogenic organisms . . .”
• “Infantis (Bi-26) [an ingredient in Probiotic 10/50] - . . . prevent growth of pathogenic organisms…prevent and treat diarrhea…”
• “Chicory Root [an ingredient in Probiotic 10/50] - . . . cure abdomen pain . . .”
• “Jerusalem Artichoke [an ingredient in Probiotic 10/50] - . . . significantly lower the blood glucose . . .”
• “To learn more about Probiotic 10/50 and its benefits for GI health and immune function, please visit: ‘Leaky Gut and Autoimmune Disease’”

Flexera™ product pages
• “Flexera™ . . . may improve joint and connective tissue function in those that suffer from pain and discomfort . . .”
• “Glucosamine Sulfate [an ingredient in Flexera]: May help prevent cartilage degeneration and arthritis.”
• “Vitamin B Complex [an ingredient in Flexera]: Controls pain and restores joint mobility.”
• “To learn more about Flexera™ and its benefits, please visit: ‘Natural Solutions for Joint Pain and Inflammation’”

PuraCell™ product pages
• “Removing obstructions from the spleen, pancreas and other organs”
• “Reduced cholesterol levels”
• “Selenium [an ingredient in PuraCell] - . . . reduces mercury toxicity”

Vitalyzm Overview webpage
• “Vitälzym is recommended to help remove scar tissue and excess fibrin in the blood, modulate immune function, and fight viruses. The proteolytic systemic enzymes may also be useful to help: autoimmune disorders, multiple sclerosis, arthritis, traumatic injuries, . . . cancer, . . . metabolic syndrome.”

Product Comparison webpage
• “Amla [an ingredient in Vitälzȳm Extra Strength and Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula)] – [U]seful for stomach problems, anemia, hyperacidity and in gynecological problems and epistaxis.”
• “Bromelain [an ingredient in Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Digest, and Vitälzȳm Xe] – notable for its effectiveness in the reduction of inflammation and decreasing swelling.”
• “Papain [an ingredient in Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), and Vitälzȳm Xe] – [E]ffective in promoting wound healing after burn . . .”
• “Rutin (Rutosid) [an ingredient in Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, and Vitälzȳm Xe] – “[L]ower ‘bad’ cholesterol and reduce the incidence of heart disease in humans.

Professional Strength Products webpage (on which you refer customers to your pages for Vitälzȳm Xe and Nättovīta™)
• “Removal of excess fibrin”
• “Post-Surgery”
o “Surgery Recovery”
o “Scar tissue removal”

Systemic Enzyme Therapy webpage [systemic enzymes highlighted among ingredients on product pages for Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, and Vitälzȳm Xe]
• “Without enzymes, we are more susceptible to diseases . . ..”
• “Systemic enzymes . . . greatly reducing pain, inflammation, circulatory impairment, and any other condition resulting from a lack of enzyme activity.”
• “Systemic enzymes support the health and well-being of the body with their significant ability to [c]ombat chronic inflammation, neutralize rogue proteins in the blood that can trigger a hyper-autoimmune response[,] [b]reak down excess fibrin that contributes to scar tissue and fibrosis[, and] [r]educe build-up in the arteries thus improving blood flow and circulation.”
• “1) Reduce Pain and Inflammation”
o Enzymes have the ability to digest and destroy the protein-based defense shield of each and every pathogen, allergen, and rogue cell thereby leading to their ultimate elimination.[] Systemic enzymes break down these substances in the blood that would otherwise create inflammation and infection. This ability may benefit those experiencing chronic inflammation, and its related pain, due to surgery, . . . injuries, etc.”
o “Healthy tissues are vulnerable to chronic inflammation and injury caused by foreign tissue growth when enzymes are too low to regulate normal repair processes. This, in turn, may lead to scar tissue and adhesion formation in the surrounding structures. Pain is often the result of these conditions and may be the first sign of a problem such as injury, fibroids, or arthritis. Reducing inflammation with Systemic Enzyme Therapy may be a useful strategy for reducing pain by way of clearing inflammation and halting the inflammatory process.”
• “2) Regulate the Immune System”
o “A balanced and well-functioning immune system ensures protection from viable pathogens while protecting healthy tissues from auto-immune antibodies. Patients who suffer from pain as part of an auto-immune response may experience relief that other treatments have failed to address. The proteolytic activity of systemic enzymes may also provide protection against virus proliferation through their ability to neutralize the defense shield of the virus, thereby preventing the virus from attaching to healthy DNA. Systemic enzymes are non-toxic and without side effects, making them a great alternative to traditional pain medications.”
• “3) Remove Excess Fibrin”
o “A primary role of systemic enzymes is to dissolve and digest non-living tissue – scars, excess fibrin which may be found in fibrous cysts in the reproductive system, and blood clots . . .”
o “Systemic Enzyme Therapy . . . [b]reaks down the rogue or ‘extra-large’ proteins circulating in the blood that can lead to pain, inflammation, and infection”
o “After previous scar and other necrotic tissues have been eliminated, enzymes continue to keep the inflammatory response in balance so that further excess fibrin does not build up again.”
• “4) Restore Blood Flow”
o “[E]nzymes clear unhealthy build-up in the circulatory system (plaque) similar to the way they ‘eat up’ excess fibrin in other systems.”
o “Systemic enzymes also improve circulation by increasing the flexibility of red blood cells, defending against the accumulation of platelets, and preventing abnormal blood clotting.”
o “Stagnant, sticky blood also plays a role in the imbalances known as endometriosis, PCOS, . . . , ovarian cysts, and uterine fibroids.”

WORLDNUTRITION.NET - Articles
• The Role of Proteolytic Enzymes [which include protease, peptidase, bromelain, papain, and nattokinase, ingredients in Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, and Nättovīta™], in Treating and Preventing Vascular and Cardiovascular Conditions, May 20, 2020
o “Coronary heart disease is caused by a blockage or narrowing of the arteries that supply blood directly to the heart and can lead to a heart attack or angina. Angina is not strictly a heart condition itself but is discomfort or pain felt in the chest, jaw, stomach, neck, or arm as a result of a restricted supply of blood to the heart. A heart attack is the result of a complete blockage of blood supply to part of the heart, usually caused by a clot forming within one of the heart’s arteries. A heart attack usually causes irreparable damage to at least one part of the heart.”
o “Nattokinase targets the molecule’s fibrin, which is derived from fibrinogen, and whose role is to assist the clotting process by coagulating blood. Due to the aging process. . . chronic inflammation . . . blood flow problems and increased risk of clotting can occur. Nattokinase is the proteolytic enzyme best placed to ensure proper blood coagulation.”
o “Proteases - An enzyme preparation designed to treat vascular and cardiovascular conditions should contain appropriate levels of proteases to provide enzyme support.”

• Fighting Viruses with Proteolytic Enzymes [which include protease, peptidase, bromelain, papain, and nattokinase, ingredients in Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, and Nättovīta™], March 23, 2020
o “Viruses can enter the human body in different ways, but most commonly (and particularly regarding the Coronavirus) by tiny droplets entering the body through the eyes, nose, or mouth. . . . While most of the world is focused on the coronavirus right now, other well-known viruses include encephalitis, chickenpox, herpes, measles, and the stealth virus. . . . Virus cells have an outer layer made of a protein called the capsid . . . Fortunately, proteolytic enzymes can destroy this protective coating, making the virus easier to destroy.”
o “Fibrin plays a helpful role when it comes to viruses: bacteria and virus cells can hide beneath a healthy blood vessel’s outer fibrin layer – making it much harder for your body’s natural defense system to find and destroy these hiding virus cells. Proteolytic enzymes have the benefit of breaking down excess fibrin, giving virus cells nowhere to hide and making it much easier for your body’s defense system to kick in and destroy the virus.”
o “One of the best-known applications of proteolytic enzymes is to bolster the human body’s overall immune system. A strong immune system will not only help the body fight off existing viruses and infections, but it can also even prevent future outbreaks from occurring at all.”
o “Research and case studies show promising results for the use of proteolytic enzymes to fight viruses like the Coronavirus.”

• Autoimmune Disease and Nutrition, March 9, 2020
o “The following conditions are examples of some of the autoimmune diseases individuals manage every day:
Celiac disease
Inflammatory bowel diseases
Lupus (SLE)
Rheumatoid arthritis (RA)
Psoriasis”
o “Systemic enzymes [systemic enzymes highlighted among ingredients on product pages for Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, and Vitälzȳm Xe] are naturally occurring and promote overall health, throughout your entire body. While these occur naturally, bodies decrease production over time. Without this support, the body may have difficulty fighting infections, repairing tissue that is injured, and fighting off disease. Supplements may help.”

• Treating Multiple Sclerosis with Proteolytic Enzymes [which include protease, peptidase, bromelain, papain, and nattokinase, ingredients in Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, and Nättovīta™], February 4, 2020
o “With no known cure and primary characterization of the progressive worsening of symptoms, multiple sclerosis has proved to be one of the hardest diseases to treat. However, patients with MS can draw hope from generally underpublicized research and clinical trials that have shown remarkable improvement in symptoms associated with multiple sclerosis with the use of proteolytic enzymes.”
o “Most remarkably, scientists and physicians who have been administering proteolytic enzyme treatment to MS patients – often in controlled studies – have seen first-hand how proteolytic enzymes can not only halt the progression of the patient’s disease but alleviate or even dissipate certain symptoms altogether.”
o “The anti-inflammatory nature of proteolytic enzymes can affect all immune complexes, not just myelin. By reducing inflammation in internal organs, blood vessels, tendons, muscles, and the skin and eyes, MS patients can find relief from other symptomatic elements of the disease.”

• 5 Easy Ways to Regulate High Blood Pressure, December 18, 2019
o “If you suffer from high blood pressure, finding ways to regulate it is a must for your overall health and well-being.”
o “Add a systemic enzyme supplement to your daily wellness routine: From healing excess scar tissue to reducing inflammation, systemic enzyme supplements can provide the body with a variety of wellness benefits–including blood pressure regulation. These supplements, especially those that contain serrapeptase [an ingredient in Vitälzȳm Xe] as a key ingredient, work well for improving blood flow circulation. Systemic enzymes [systemic enzymes highlighted among ingredients on product pages for Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, and Vitälzȳm Xe] break down plaque and other debris that may be blocking the flow of blood. This makes circulation much easier on your body and takes some pressure off of the heart and arteries.

If you’re looking for an effective and affordable systemic enzyme supplement, learn more about World Nutrition’s Vitalyzm.”

WORLDNUTRITION.NET - Videos
• Nättovīta Overview by Dr. Donese Worden
o 00:26 – 00:41: “[The possible indications of nattokinase (an ingredient in Nättovīta)] are for . . . reduction in dementia, prevention of osteoporosis, strokes, heart disease, hypertension, and intestinal disorders.”
o 00:44 – 00:54: “Nattovita’s ingredients include vitamin E, a potent antioxidant that can mitigate damaged tissue, platelet aggregation . . ..”
o 01:25 – 01:43: “CoQ10 [an ingredient in Nättovīta] . . . now current studies looking into neurodegenerative diseases particularly Parkinson’s. It is also helpful in improving blood pressure and glycemic control.”
o 01:45-01:48. . .: “[Folic acid, an ingredient in Nättovīta] may help prevent folic acid deficiency anemias . . ..”
o 01:52 – 02:06: “Proteinase [an ingredient in Nättovīta]. . . may also help reduce symptoms of food allergies, rheumatoid arthritis, and other autoimmune diseases.”
o 02:119 – 02:18: “Bromelain and papain [ingredients in Nättovīta]. . . decrease pain and vascular inflammatory responses.”
o 03:15 – 03:27: “Many physicians . . . have seen nattokinase’s ability to lower blood pressure. In Japan it is utilized for childbirth due to its . . . antibacterial effects.”

• Vitälzȳm Liquid Gel Overview by Dr. Donese Worden
o 00:48 – 01:07: “When considering this product for your patients, consider using the liquid caps for inflammation, fibrosis . . . antiviral properties . . . decreasing pain and inflammation”
o 01:07 – 01:15: “Ingredients include bromelain, an enzyme found in pineapple that numerous studies have shown to have anti-inflammatory properties.”
o 01:43 – 01:54: “Other studies show potential to treat severe gastrointestinal disease and diabetes. Another interesting study shows rutin flavonoids [an ingredient in Vitälzȳm] inhibiting platelet aggregation.”
o 02:26 – 02:37: “One study in the Journal of Human and Experimental Toxicology showed serrapeptidase and nattokinase [ingredients in Vitälzȳm] intervention relieving Alzheimer’s disease pathophysiology in a rat model.”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

WORLDNUTRITION.NET – Testimonials
• Dorothy J.: “I’ve had Fibromyalgia for 17 years, all over my body . . .. After four days of taking Vitalzym, I have 75 percent less soreness, 50 percent less stiffness and MOST of my pain is gone. . . . I’m going to get my husband, who is diabetic and has had back surgery, on Vitalzym right away. . . .”
• Toni M.: “I had Fibromyalgia and was tired all the time. I was in constant pain. Vitalzym helped me with muscle aches . . .. Vitalzym also lowered my cholesterol level from 278 to 164.”
• V.F: “I take Vitalzym for uterine fibroids. . . . If you have heavy bleeding associated with fibroids DON’T suffer with it. The cramps dissipate, as does the heavy bleeding. . . .”

Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, Nättovīta™, Ketsumeisei™, Probiotic 10/50 by Vitälzȳm, Flexera™, and PuraCell™ 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 based on 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 Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, Nättovīta™, Ketsumeisei™, Probiotic 10/50 by Vitälzȳm, and PuraCell™ 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 these products safely for the intended purposes. Accordingly, Vitälzȳm Extra Strength, Vitälzȳm Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitälzȳm Cardio, Vitälzȳm Digest, Vitälzȳm Xe, Nättovīta™, Ketsumeisei™, Probiotic 10/50 by Vitälzȳm, and PuraCell™ fail to bear adequate directions for their intended uses 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 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 the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation, such as photographs, corrective actions taken to date, or other useful information that would assist us in evaluating your corrections. 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 corrections. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at (303) 236-3094 if you have any questions about this matter.

Sincerely,
/S/

Mark Harris
Acting Denver District Director &
Program Division Director
Office of Human and Animal Food Operations –
Division IV West