WARNING LETTER
Walmart Inc.
MARCS-CMS 631755 —
October 28, 2022
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Doug McMillon
Recipient Title
CEO
Walmart Inc.
702 SW 8th Street
Bentonville
,
AR
72716-6299
United States
HWSCSAFETY@wal-mart.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
October 28, 2022
RE: 631755
Dear Mr. McMillon:
This letter concerns your firm’s distribution of the “Artri King Reforzado con Ortiga y Omega 3” product that violates the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). As discussed below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of this product, which is an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, this product is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a). You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
FDA purchased “Artri King Reforzado con Ortiga y Omega 3” through your website, www.walmart.com. The product, which is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), was introduced or delivered for introduction into interstate commerce by Walmart via your Walmart Fulfillment Services.
1
FDA confirmed through laboratory analyses that the “Artri King Reforzado con Ortiga y Omega 3” purchased on Walmart.com contained the active pharmaceutical ingredient (API) diclofenac, which is not listed on the product label.
2
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID).
3, 4
NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. The undeclared diclofenac ingredient in “Artri King Reforzado con Ortiga y Omega 3” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Unapproved New Drugs
“Artri King Reforzado con Ortiga y Omega 3” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Examples of claims observed on the labeling of “Artri King Reforzado con Ortiga y Omega 3” that establish the intended use of this product as a drug include, but may not be limited to, the following:
“PROPRIEDADES” (English translation:
PROPERTIES
)
“Altamente eficaz en la reconstruccion del cartílago.” (English translation:
Highly effective in restoring cartilage
.)
“Combate la artritis.” (English translation:
Fights arthritis
.)
“Detiene el avance de deterioro en articulaciones.” (English translation:
Stops the progress of joint deterioration
.)
“Antiinflamatorio y analgésico.” (English translation:
Anti-inflammatory and analgesic
.)
“Eficaz en problemas de articulaciones de lesiones deportivas.” (English translation:
Effective for joint problems due to sports injuries
.)
“Beneficia a personas que padecen de procesos degenerativos como artritis y osteoartritis.” (English translation:
Benefits people suffering from degenerative processes such as arthritis and osteoarthritis
.)
“Mejora la movilidad y normal funcionamiento de las articulaciones.” (English translation:
Improves mobility and normal functioning of joints
.)
“Artri King Reforzado con Ortiga y Omega 3” is not generally recognized as safe and effective for the above referenced uses and therefore is a “new drug” under section 201(p) of the FD&C 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 the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for “Artri King Reforzado con Ortiga y Omega 3.” Introduction or delivery of this product into interstate commerce without an approved application violates sections 301(d), 21 U.S.C. 331(d), and 505(a), 21 U.S.C. 355(a) of the FD&C Act.
In addition, “Artri King Reforzado con Ortiga y Omega 3” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article's labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for “Artri King Reforzado con Ortiga y Omega 3” does not declare that the products contain the drug ingredient diclofenac. As discussed earlier, diclofenac can lead to adverse cardiovascular events, such as heart attack and stroke, or serious gastrointestinal damage, including bleeding, ulceration, and fatal tears of the stomach and intestines, or liver toxicity including liver failure that can cause the need for a liver transplant or death. The failure to disclose this ingredient in the product’s labeling renders “Artri King Reforzado con Ortiga y Omega 3” misbranded under section 502(a) of the FD&C Act.
The introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. 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/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining 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 believe that the product you distribute is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within fifteen working days from the date of receipt of this letter.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
__________________________
1
Walmart distributes the product directly to individual U.S. consumers on behalf of third parties. The product discussed below was “fulfilled” by Walmart; your website states, “
Walmart Fulfillment Services (WFS) offers end-toend fulfillment services for third-party ecommerce sellers. With one of the world’s largest supply chains, we’re uniquely positioned to provide the scale, quality, cost, and efficiency you need to grow a successful business on Walmart.com. . . . 4. We store, pick, pack, and ship your orders 5. We handle customer care and returns (in store or home pickup
).” (see https://marketplace.walmart.com/walmart-fulfillment-services/).
2
U.S. Food & Drug Administration,
Public Notification: Artri Ajo King contains hidden drug ingredient
, (January 5, 2022),
https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-ajo-king-contains-hidden-drug-ingredient
; U.S. Food & Drug Administration (@FDA_Drug_Info), Twitter (March 4, 2022, 3:07PM) https://twitter.com/FDA_Drug_Info/status/1499838990631026689; U.S. Food & Drug Administration,
Consumer Alert: Artri Ajo King
, Facebook (March 4, 2022), https://www.facebook.com/FDA/posts/328441589313206; U.S. Food & Drug Administration,
Public Notification: Artri King contains hidden drug ingredient
, (April 20, 2022),
https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-king-contains-hidden-drug-ingredients
; U.S. Food & Drug Administration,
Public Notification: Ortiga Mas Ajo Rey contains hidden drug ingredient
, (April 20, 2022),
https://www.fda.gov/drugs/medication-health-fraud/public-notification-ortiga-mas-ajo-rey-contains-hidden-drug-ingredient
; U.S. Food & Drug Administration,
Public Notification: Ortiga Mas Ajo Rey - Extra Forte contains hidden drug ingredient
, (April 20, 2022),
https://www.fda.gov/drugs/medication-health-fraud/public-notification-ortiga-mas-ajorey-extra-forte-contains-hidden-drug-ingredients
; U.S. Food & Drug Administration,
FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients
, (April 20, 2022),
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-artri-and-ortiga-products-which-may-contain-hidden-drug
.
3
Please be advised that under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. § 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act, unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Voltaren (containing diclofenac sodium as the active ingredient) as a new drug on July 28, 1988. Prior to that date, diclofenac had not been marketed as a food or dietary supplement. Given that diclofenac was not marketed as a dietary supplement or as a food before Voltaren was approved, a product marketed as a dietary supplement that contains diclofenac is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act. Furthermore, a product marketed as a dietary supplement that is intended for the treatment of arthritis is also a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
4
We also note that the labeling of the product appears to violate Walmart’s policies prohibiting dietary supplements with disease claims from being listed on Walmart Marketplace: https://gecrm.my.salesforce.com/sfc/p/61000000ZKTc/a/4M000000LnEm/YFluE07nRPxGwEBEosayC29sEDWdKBGNLikZxfiLL8c.
Content current as of:
11/01/2022
Regulated Product(s)
Drugs