WARNING LETTER

Smarter Nutrition, Inc. MARCS-CMS 610024 — December 28, 2020

Delivery Method:: United Parcel Service
Product:: Drugs
Food & Beverages

Recipient:: Recipient Name

Daqing Goa; Recipient Title

President; Smarter Nutrition, Inc.; 17870 Newhope St. Suite 104-480
Fountain Valley, CA 92708
United States

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

WARNING LETTER

December 28, 2020

WL 610024

Dear Mr. Goa:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://smarternutrition.com in December 2020 and has determined that you take orders there for the products Smarter Curcumin, Smarter Ubiquinol, and Smarter Vitamin D3. We have also reviewed your social media website at https://www.facebook.com/smarternutrition1, which directs consumers to your website https://smarternutrition.com to purchase your products. In addition, we observed that your Smarter Vitamin D3 product is intended to mitigate, prevent, treat, or cure COVID-19¹ in people. The claims on your website and social media 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 diagnosis, 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 claims observed on your website https://smarternutrition.com establish the intended use of your products as drugs include:

On your product webpage for Smarter Curcumin:
• “Curcumin Helps to Fight Free Radical Damage and Inflammation in the Body!”
• “Curcumin not only helps to enhance the responses of certain antibodies and cells within the immune system but may also help downregulate the expression of certain proinflammatory substances.”
• “Neurons are especially susceptible to inflammation and the release of inflammatory compounds in the body can be neurotoxic. Curcumin may help protect those precious brain cells.”

In the video on the product webpage for Smarter Curcumin:
• “[M]aybe even fight cancer”
• “How to Choose the Right Turmeric For Your Aching Joints!”
• “Maximizing Curcumin’s Inflammation and Pain-fighting Benefits”
• “The raw spice turmeric, which curcumin comes from . . . remains a staple for addressing inflammation, joint issues, and as a cure all for a multitude of health concerns.”
• “Curcumin taken correctly has been clinically shown to knock out unhealthy inflammation in the body. It does this specifically by reducing two key inflammation promoting enzymes in the body.”
• “And there’s [sic] even more curcumin health benefits, including . . . stabilizing your blood sugar. . . .”

On your product webpage for Smarter Ubiquinol:
• “Targets free radicals that can damage ovaries and contribute to infertility”

Additional claims observed on your blog site https://smarternutrition.com/blogs/news include:

On the blog post “When the Joints Wear Down: Dealing with Osteoarthritis” posted November 15, 2019, which includes a link to the product page for Smarter Curcumin, and the embedded video:
• “You can also take some natural things to help reduce inflammation, such as Smarter Curcumin . . ..”
• [As part of a discussion involving products including Smarter Curcumin] “These are natural products that you can use to reduce inflammation and help support your joints without getting into you the synthetic medications and their associated side effects.”

On the blog post “Spine Health and Inflammation” posted July 8, 2019, which includes a link to the product page for Smarter Curcumin:
• “Natural Supplements: Consider using a natural supplement such as curcumin to help with the inflammation. Curcumin has been shown in studies and clinical trials to promote a healthy response to inflammation in the body, making it a great supplement to help with both acute and chronic inflammation, so long as it’s combined with the right support ingredients.”

On the blog post “Top 5 Clean Supplements for Reducing Inflammation” posted on March 18, 2019, which includes a link to the product page for Smarter Curcumin:
• “Part of the inflammation-fighting effect of curcumin comes from its ability to inhibit key enzymes in the body known to promote inflammation.”
• “Black seed oil [an ingredient in Smarter Curcumin] . . . inflammation fighter”
• “Ginger root [an ingredient in Smarter Curcumin] contains chemicals that help reduce inflammation. It also . . . reduces nausea. Researchers believe the chemicals in ginger work in both the stomach and intestines and in the brain and nervous system to tame the flames of inflammation.”

On the blog post “Minimizing the Mental and Physical Impact of Covid-19” posted March 24, 2020, which includes a link to the product page for Smarter Vitamin D:
• “And while there isn’t a vaccine or a cure for the COVID-19 virus, there are plenty of steps you could, and should, be taking to strengthen your immune system. . . . In fact, recent research shows us that supplementing with vitamin D on a regular basis could help your body fight off a respiratory illness—and not by just a little. Get this: in one study, older adults who supplemented with increased amounts of vitamin D on a regular basis had 40% less respiratory infections than those who took a regular, standard dose. The study also concluded that supplementing with vitamin D showed an overall protective effect against acute respiratory tract infections.”
• “[I]f you want an overall stronger immune system and if you want to help decrease your risk of respiratory infection, then supplement with a high-quality source of vitamin D. The ‘high quality’ part is where it gets tricky. . . . Smarter Vitamin D checks all these boxes . . .”

You posted a video to your Facebook page on March 24, 2020, with an accompanying caption that says, “On today’s live show Dr. Nancy Lin, holistic nutritionist talks more COVID-19, this time focusing on what to do to be least impacted by the virus – which means building stronger immune health now! . . . Watch today’s show and take back control!” and links to the above blog post “Minimizing the Mental and Physical Impact of Covid-19.” The video says:
• [Starting with 11:03 remaining] “In fact, recent research shows us that supplementing with Vitamin D on a regular basis could help your body fight off a respiratory illness and not by a little. . . . Older adults who supplemented with increased amounts of vitamin D on a regular basis . . . have 40% less respiratory infections than those who took a regular standard dose. It also concluded that supplementing with vitamin D showed an overall protective, a protective effect of Vitamin D supplementation against acute respiratory tract infections. Those are big. Those are big statistics. What more do you really need to know, right? Especially with what we are going through right now. Vitamin D, are you telling me I can boost my whole body immune system with this, and my respiratory? Great. Tell me where, where do I get it? If you want an overall stronger immune system and if you want to help decrease your risk of respiratory infection, then supplementing with a high quality—that’s key though—high quality source of vitamin D is imperative. Imperative. But the high quality part, what I just touched about is where it gets a little tricky. . . . Let me show you the only Vitamin D supplement that I use and the only one that I recommend to my clients. [Holds up computer screen showing Smarter Vitamin D3] . . . This is Smarter Nutrition’s Vitamin D Plus K2. . .”

Your Smarter Curcumin, Smarter Ubiquinol, and Smarter Vitamin D3 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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 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 product Smarter Curcumin and Smarter Vitamin D3 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 product safely for its intended purposes. Accordingly, Smarter Curcumin and Smarter Vitamin D3 fail to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug 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 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your written response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612

Refer to Unique Identification Number 610024 when replying.

If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at elodie.tong-lin@fda.hhs.gov.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5

_______________________________

1 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, the President declared 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 product for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.