Inspections, Compliance, Enforcement, and Criminal Investigations
HUMAN SCIENCE FOUNDATION 8/18/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
August 18, 2014
Mr. Sean S. Lee, President/Owner
Human Science Foundation
13722 Harvard Pl
Gardena, CA 90249-2527
Dear Mr. Lee:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 13722 Harvard Pl, Gardena, CA 90249 from January 8 through 16, 2014. During the inspection, the FDA investigator collected samples of "Pro ArthMax" and "Super Arthgold" products. Based on our review, your "Pro ArthMax" and "Super Arthgold" products are unapproved drugs in violation of section 505(a) of the Federal Food, Drug and Cosmetic Act ("FD&C Act") [21 U.S.C. § 355(a)] and are misbranded in violation of sections 502 and 503(b)(1)(A) [21 U.S.C. §§ 352 and 353(b)(l)(A)] of the FD&C Act. The introduction or delivery for introduction into interstate commerce of these products would violate sections 301(d) and 301(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 331(a)].
FDA laboratory analyses confirmed the following undeclared ingredients in your distributed products:
• "Pro ArthMax" - Chlorzoxazone, Diclofenac, Indomethacin, Ibuprofen, Naproxen, and Nefopam.
• "Super Arthgold" - Chlorzoxazone, Diclofenac, and Indomethacin.
Chlorzoxazone is the active pharmaceutical ingredient (API) in the FDA-approved drug Parafon Forte® DSC, approved on August 15, 1958, and is a prescription drug used to relieve musculoskeletal pain. Diclofenac, indomethacin, ibuprofen, and naproxen are non-steroidal anti-inflammatory drugs (NSAIDs) and APIs found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions, including some arthritic conditions.1 Nefopam is a non-opioid analgesic and is not approved for use in the United States.
Your firm's "Pro ArthMax" and "Super Arthgold" products are labeled as dietary supplements. However, due to the presence of the aforementioned APIs that are in FDA-approved drugs, they cannot be dietary supplements under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)], because a dietary supplement cannot contain 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 prior to FDA approval of the article in a new drug. Given that neither chlorzoxazone, diclofenac, indomethacin, ibuprofen, nor naproxen were marketed as dietary supplements or as foods before FDA's approval of Parafon Forte® DSC, Voltaren®, Indocin®, Motrin®, and Naprosyn®, your "Pro ArthMax" and "Super Arthgold" products are excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the FD&C Act.
Your products "Pro ArthMax" and "Super Arthgold" are drugs, as defined by section 201 (g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)], because they are intended to diagnose, mitigate, prevent, treat, or cure disease conditions and/or affect the structure or function of the body. The "intended use" refers to the objective intent of the persons legally responsible for the labeling of drugs and the intent may be shown by the circumstances surrounding the distribution of the article [21 CPR § 201.128]. The intended use of a product may be established through, for example, product labels and labeling (including the name of a product), advertising materials (e.g., catalogs, brochures), or other circumstances surrounding the marketing and distribution of the product.
Claims documenting the intended use of your products include, but are not limited to, the following:
• "Promotes healthy joints & cartilage"
• "Better Performance ... Better Flexibility ... Better Mobility"
• "With Pro ArthMax, they could work better, move better, and feel better."
• "Super Arthgold is an 'All-Natural Source Formula' that has been known to help with arthritis, joint, and muscle-related aches and pains."
• "Super Arthgold may improve the blood circulation, which can help relieve soreness caused by lactic acid build-up in the muscle tissues. Better blood flow can also contribute to increased range of motion in the joints, which may help arthritis and joint pain."
Moreover, "Pro ArthMax" and "Super Arthgold" are new drugs, as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because the products are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your distribution of "Pro ArthMax" and "Super Arthgold" without approved applications violates these provisions of the FD&C Act.
Furthermore, "Pro ArthMax" and "Super Arthgold" are "prescription drugs" as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or other potentiality for harmful effect, or the methods of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs. For example, chlorzoxazone, the muscle relaxant found in both your products, which has been approved for marketing by FDA, is limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drug.
According to section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write "adequate directions for use" for prescription drugs. As such, the labeling of "Pro ArthMax" and "Super Arthgold" fails to bear adequate directions for their intended use. They are not exempt from the requirement that their labeling bear adequate directions for use under 21 CFR §§ 201.100(c)(2) and 201.115 because no FDA-approved applications are in effect. For these reasons, "Pro ArthMax" and "Super Arthgold" are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
Additionally, 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 label of "Pro ArthMax" does not declare that it contains chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and nefopam. Similarly, the label of "Super Arthgold" does not declare that it contains chlorzoxazone, diclofenac, and indomethacin. The undeclared drug ingredients found in these products may pose serious health risks because consumers with underlying medical issues may take them without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, the NSAIDs (i.e., diclofenac, indomethacin, ibuprofen, and naproxen) found in your products could lead to serious gastrointestional (GI) adverse events such as bleeding, ulceration, and fatal perforation of the stomach and intestines. Patients who are already taking medication that could cause bleeding may increase their risk for bleeding significantly by taking your products. Your products "Pro ArthMax" and "Super Arthgold" are misbranded under section 502(a) of the FD&C Act, because their labeling fails to reveal facts material with respect to consequences that may result from the use of these products. Your failure to disclose the presence of chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and nefopam also renders your products' labeling false and misleading under section 502(a) of the FD&C Act.
The undeclared drug ingredients in your products "Pro ArthMax" and "Super Arthgold," cause your products to also be misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], because their labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with these products, particularly since someone who takes them would be unaware of the presence of chlorzoxazone, diclofenac, indomethacin, ibuprofen, naproxen, and/or nefopam found in these above-mentioned products.
The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
The above is not intended to be an all-inclusive list of violations 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. In addition to the cited violations mentioned above, you have not provided a response to the Inspectional Observations (Form FDA 483) issued to you at the conclusion of the inspection. The observations noted in the Form FDA 483 reviews serious good manufacturing practice (GMP) deficiencies at your facility. It is your responsibility to assure your firm complies with all requirements of the federal law and FDA regulations.
FDA acknowledges that you initiated a voluntary nationwide recall of"Pro ArthMax" (all lots) on January 13, 2014. It is your responsibility to make certain that you do not market or distribute any product with potentially harmful and undeclared ingredient(s).
You should take prompt action to correct all 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. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your firm's response should be sent to: Acting Director, Compliance Branch, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612-2506. If you have any questions about the content of this letter, please contact: Dr. Raymond W. Brullo at (949) 608-2918.
Alonza E. Cruse, Director
Los Angeles District
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence
1 Diclofenac is the API in the FDA-approved drug Voltaren®, approved on July 28, 1988; indomethacin is the API in the FDA-approved drug Indocin®, approved on June 10, 1965; ibuprofen is the API in the FDA-approved drug Motrin®,approved on September 19, 1974; and naproxen is the API in the FDA-approved drug Naprosyn®, approved on March 11, 1976.