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  5. Orphic Nutrition - 612470 - 04/13/2021
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WARNING LETTER

Orphic Nutrition MARCS-CMS 612470 —

Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Mr. Bryce Alderson/Ms. Melisa Vong
Orphic Nutrition

2443 Fillmore Street Suite # 380-7475
San Francisco, CA 94115-1814
United States

Issuing Office:
Office of Human and Animal Food Operations –West Division 5

United States

WARNING LETTER


WL 612470 

Dear Mr. Alderson and Ms. Vong:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at Internet address www.orphicnutrition.comand your Amazon storefront at https://www.amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln in March 2021 and has determined that you take orders on both websites for your Orphic Nutrition brand products Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, Omega 3 Fish Oil Softgels, and Turmeric Curcumin with Bioperin Capsules. The claims on your websites 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 website claims that provide evidence that your products are intended for use as drugs include:

Apple Cider Vinegar Capsules

On your website https://orphicnutrition.com/products/apple-cider-vinegar-capsules:
• “Improve Blood Sugar Control”
• “The acetic acid in apple cider vinegar helps lower high triglycerides and cholesterol levels. It can also decrease high blood pressure”
• “Removes unwanted bacteria and other harmful toxins from the body…”
• “The naturally founded [sic] probiotics in apple cider vinegar aid with constipation, gastroparesis…diarrhea, and leaky gut…”
• [From an image of your product label on your website] “Apple Cider Vinegar…is known for its…benefits including…high blood pressure… acne… common cold…”

On your webpage titled “HEALTH BENEFITSOF APPLE CIDER VINEGAR” (https://orphicnutrition.com/blogs/news/health-benefits-of-apple-cider-vinegar) where you also provide a hyperlink to the firm’s shop page for Orphic Nutrition Apple Cider Vinegar capsules:
• “The History of Apple Cider Vinegar

It also served as a mean of preventing infectious diseases.

. . . It was an obligatory preparation in an ancient Egyptian healer’s bag to treat infectious diseases . . .. Throughout history, apple cider vinegar remained popular for curing various diseases. Hippocrates advised taking it for coughs and colds. The Italian physician Tommaso del Garbo washed his hands, face, and mouth with vinegar during the plague in 1348 to prevent infection.”

• “And it [apple cider vinegar] hasa positive effect in the treatment of allergic diseases . . ..”
• Potassium, which you assert is present in Orphic Nutrition Apple Cider Vinegar: “saves from insomnia and headaches”
• “Helps With Stomach Acids…And Nausea…”
• “Acid reflux is characterized by the backflow of acid from the stomach into the esophagus, causing symptoms such as heartburn, belching, and nausea. It is often the result of low stomach acid levels. If that’s the case, then taking apple cider vinegar in capsules can help you eliminate unpleasant symptoms. It injects more acid into your digestive tract to prevent backflow.”
• “Apple Cider Vinegar has an active amount of Vitamin E. It is a powerful antioxidant that neutralizes free radicals’ negative effects on the body. Free radicals cause . . . immune system disorders, heart disease, cataracts, and cancer.”
• Potassium, which you assert is present in Orphic Nutrition Apple Cider Vinegar: “reduces blood pressure”
• “Maintain Diabetes Level: . . . Research shows that apple cider vinegar, taken in combination with the last meal of the day, reduced blood glucose levels the next morning. . . . Suppose you have diabetes in a family or are already a Type 2 diabetic. In that case, apple cider vinegar intake can have a real value in controlling blood sugar.”

Ashwagandha Capsules

On your website https://orphicnutrition.com/products/ashwagandha:
• “An Ancient Medical Herb Used To … Reduce Inflammation…”
• “[I]mproves…blood sugar levels…”
• “Reduces Inflammation Affects the function of Natural Killer cells which reduces the inflammation in various parts of the body.”
• “Targets the hormone cortisol which helps…normalize blood pressure”

On your webpage titled “WHY ASHWAGANDHA IS THE STRESS RELIEVER, [sic] YOU NEVER KNEW YOUNEEDED” on your website https://orphicnutrition.com/blogs/news/why-ashwagandha-is-the-stress-reliever-you-never-knew-you-neededwhere you display a photograph of Ashwagandha capsules and provide a hyperlink to the firm’s shop page for Ashwagandha capsules:
• “Ashwagandha is a popular herb of the 3000-years-old Ayurvedic medicine system, which uses herbs and other natural remedies for the treatment of various diseases.”
• “Ashwagandha helps reduce the symptoms of depression”
• “Ashwagandha reduces the blood glucose level in . . . diabetics. The key substance of Ashwagandha: Withaferin, improves the glucose uptake by the muscle cells and other anti-diabetic activity.”
• “Ashwagandha may have possible anti-cancer effects Withaferin, a compound found in Ashwagandha helps induce apoptosis (programmed cell death of cells) of the cancerous cells. It also interferes with the growth of cancerous cells in many ways and impedes their production. Ashwagandha promotes the formation of highly reactive species of oxygen that disrupts the cancerous cells from within.”
• “Antipsychotic drugs used to treat schizophrenia have an adverse effect that leads to the deposition of fat because of increased levels of sugar and fats in the blood. Using Ashwagandha helps in reducing elevated levels of fat and sugar in the blood, thus compensating the adverse effects of antipsychotic drugs.”
• “It [Ashwagandha] mitigates the harmful effects caused by brain disease or injury.”
• “Ashwagandha is used for its positive role in reducing inflammation, Attention deficit-hyperactivity disorder (ADHD), rheumatoid and osteoarthritis, liver problems, parkinsonism, tuberculosis, and other medication conditions.”
• “Ashwagandha also helps the body cope with anxiety, cancers, depression, arthritis, sleep disorder…”

Garcinia Cambogia Capsules
On your webpage titled “GARCINIA CAMBOGIA SUPPLEMENT – HEALTH BENEFITS” (https://orphicnutrition.com/blogs/news/garcinia-cambogia-supplement-health-benefits) where you display a photograph of the Garcinia Cambogia Capsules and provide a hyperlink to the firm’s shop page for Orphic Nutrition Garcinia Cambogia Capsules
• Under the subheader “Medicine”: “[L]ower bad cholesterol…”
• “A Folk Remedy For Cancer To prevent cancer,many people in Asia choose to use traditional medicine such as Garcinia Cambogia. . . . Garcinia Cambogia may be beneficial in cancer prevention due to its phytochemicals and antioxidants. . . . These phytochemicals and antioxidants help protect against . . . cancer cell growth.”
• “Helps To Fight Against Cholesterol Another extraordinary health benefit of Garcinia Cambogia fruit is that it helps lower bad cholesterol, leading to protection from stroke and other diseases. The Garcinia Cambogia fruit itself is devoid of cholesterol.”
• “[T]his [Garcinia Cambogia] fruit can . . . treat acne.”
• “Helps Prevent Fungal & Bacterial Infections The nutrients in Garcinia Cambogia fruit are believed to prevent fungal and bacterial infections in wounds. . . . Garcinia Cambogia contains xanthones, a chemical effective against the bacteria Tuberculosis.”

Premium Collagen Peptides Capsules
On your webpage titled “THE TYPES AND BENEFITSOF COLLAGENPEPTIDES: A COMPLETE GUIDE” (https://orphicnutrition.com/blogs/news/the-types-and-benefits-of-collagen-peptides-a-complete-guide), where you display a photograph of your Collagen Peptide and provide a hyperlink to the firm’s shop page for Orphic Nutrition Premium Collagen Peptides Capsules:
• “Joint Diseases . . . Destructive and inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, arthritis, etc.). . . . Degenerative and inflammatory changes in themusculoskeletal system. . . . Prevention of diseases of the spine and joints . . ..”
• “Bechterew’sDisease Collagen Peptides contain sulfur that significantly enhances the therapeutic effect. Sulfur strengthens the immune system and normalizes cellular activity, which reduces inflammatory processes that provoke swelling and impaired joint mobility.”
• “Sleep Disorders Glycine, which is part of the protein, has a mild sedative . . .effect.”

Elderberry Gummies
On your webpage titled “5 REASONS TO LOVE ELDERBERRY” (https://orphicnutrition.com/blogs/news/5-reasons-to-love-elderberry), where you display a photograph of your Elderberry Gummies and provide a hyperlink to the firm’s shop page for Orphic Nutrition Elderberry Gummies:
• “They [elderberries] can help reduce the severity of viral infections and shorten the duration if you get sick.”
• “It’s good to supplement with elderberry gummies ideally within 24 hours of getting initial symptoms of cold or flu.”
• “Protects against heart diseases . . . [E]lderberries can help improve heart health and reduce cardiovascular diseases. Elderberries are packed with healthy phytonutrients and soluble fiber which help reduce blood pressure and cholesterol.”
• “Because it [elderberry] also has antibacterial properties, it can also help fight acne.”
• “Elderberry provides an organic and natural way to prevent diseases . . .. Research is showing that it even has the potential to lower blood sugar and even fight cancer.”

Omega 3 Fish Oil Softgels
On your website https://orphicnutrition.com/collections/shop-all/products/burpless-lemon-flavored-omega-3-fish-oil-capsules:
• “Omega 3 has plague [sic] reducing effects in arteries and a decreased potential for blood clot formation. This reduces the risk of heart related issues.”
• “Omega 3…reduces inflammation.”
• “EPA Reduces…acne, improves wound healing, and treatment for skin conditions.”
• “DHA Helps resolve eye problems as well as reducing the risk of developing age-related macular degeneration.”

Turmeric Curcumin with Bioperin Capsules
On your website https://orphicnutrition.com/collections/shop-all/products/turmeric-curcumin-with-bioperine:
• “Natural Anti-Inflammatory Supplement Reduces Joint Discomfort, Soreness, & Stiffness…”
• “Anti-Inflammatory Naturally prevents and reduces inflammation in the joints…”
• “Improves the function of the endothelium which can help with heart related issues. Also is an antiplatelet agent which decreases the risk of blood clot formation.”
• “Increases levels of Brain-Derived Neurotrophic Factor which is a protein that…reduces the risk of brain related disorders.”
Furthermore, you operate an Amazon storefront under the name Orphic Nutrition. We reviewed your product listings for Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, and Turmeric Curcumin with Bioperin Capsules. The product descriptions on these listings provide evidence that these products are intended for use as drugs include the following:

On the Apple Cider Vinegar Capsules webpage, https://www.amazon.com/Strength-Capsules-Bloating-Non-Stimulating-Digestion/dp/B07B2BS1FK/ref%3Dsr_1_7?dchild=1&keywords=orphic%2Bnutrition&qid=1606890827&sr=8-7
• “Indications…lowers blood sugar and fights diabetes, lower cholesterol.”

On the Ashwagandha Capsuleswebpage, https://www.amazon.com/Ashwagandha-Anti-Anxiety-Supplements- Orphic- Nutrition/dp/B07NZ8Q3V9/ref=sr_1_9?dchild=1&keywords=orphic+n utrition&qid=1606893310&sr=8-9:
• “Anti-Anxiety Supplements…”
• “Ashwagandha is an ancient medicinal herb used to . . . reduce inflammation . . .. It helps prevent joint pain and inflammation . . ..”
• “Indications…Regulate blood sugar levels…lowers cholesterol”

On the Garcinia Cambogia Capsuleswebpage, https://www.amazon.com/Garcinia-Cambogia-Suppressant-Non- Stimulating- Metabolism/dp/B07B6KS2HK/ref=sr_1_5?dchild=1&keywords=orphi c+nutrition&qid=1606894064&sr=8-5:
• “Indications…Regulate blood sugar levels…lowers cholesterol”

On the Turmeric Curcumin with Bioperin Capsules webpage, https://www.amazon.com/Turmeric-Curcumin-Bioperine-Antioxidant-Inflammatory/dp/B07V2SBZBX/ref=sr_1_12?dchild=1&keywords=orphic+nutrition&qid=1606931163&sr=8-12:
• “THEY [your turmeric curcumin products] HELP PREVENT HEART DISEASE, ARTHRITIS…”
• “The curcuma longa root in our product may help to improve heart function with its anti-platelet agent.”
• “Anti-Inflammatory”

Your Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, Omega 3 Fish Oil Softgels, and Turmeric Curcumin with Bioperin Capsules 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)]. 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 Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, and Omega 3 Fish Oil Softgels 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, Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, and Omega 3 Fish Oil Softgels 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 mattermay 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 electronic written response to:
orahafwest5firmresponses@fda.hhs.gov

Hardcopy response can be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502

Refer to Unique Identification Number 612470 when replying.

If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at Kimberly.Lichter@fda.hhs.gov or (949) 608-2967.

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: Mr. Bryce Alderson
Ms. Melisa Vong
10478156 Canada Incorporated
Dba Orphic Nutrition
661 Mill Park Drive
Kitchener, ON N2P1V4

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