Inspections, Compliance, Enforcement, and Criminal Investigations

MS Bionic 5/3/17

 

  

Black HHS-Blue FDA Logo

 

Los Angeles District
19701 Fairchild, Irvine CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417

 
 

 

WARNING LETTER
WL#28-17
 
VIA United Parcel Service
 
May 3, 2017
 
Mr. Maxwell Kim
MS Bionic
447 E Gardena Blvd
Gardena, CA 90248-2913
 
Dear Mr. Kim,
 
The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 447 E Gardena Blvd in Gardena, CA on November 15, 2016 through December 5, 2016. Based on our inspection and review of your product labels, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
 
Unapproved New Drugs
 
FDA obtained a sample of your product, “Megajex.” As described below, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Act
[21 U.S.C. §§ 355(a) and 331(d)].
 
Specifically, FDA confirmed through laboratory analysis that a sample of your “Megajex” product contains the following undeclared active pharmaceutical ingredients:
 
 Product Name
Undeclared Active Pharmaceutical Ingredient(s)
Megajex
sildenafil; tadalafil
 
Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Viagra™, an FDA-approved prescription drug used to treat erectile dysfunction (ED). Tadalafil is also a PDE-5 inhibitor and is the active ingredient in Cialis™, another FDA-approved prescription drug used to treat ED.
 
Your “Megajex” product is marketed as a dietary supplement, with the product label identifying the product as an “Herbal Supplement.” However, under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement cannot contain an article that is approved as a new drug under section 505(a) of the Act [21 U.S.C. § 355(a)] unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug. FDA approved Viagra™ (containing sildenafil as the active ingredient) as a new drug on March 27, 1998. Given that sildenafil was not marketed as a dietary supplement or as a food before Viagra™ was approved, “Megajex,” which contains sildenafil, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FDCA [21 U.S.C. § 321(ff)(3)(B)(i)]. FDA approved Cialis™ (containing tadalafil as the active ingredient) as a new drug on November 21, 2003. Given that tadalafil was not marketed as a dietary supplement or as a food before Cialis™ was approved, “Megajex” which contains tadalafil, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FDCA on the basis of their tadalafil content as well.
 
Moreover, this product and your “Casanova Plus” product are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are intended to prevent, treat or cure disease conditions and/or affect the structure or function of the body. Labeling statements documenting the intended use of “Megajex” and “Casanova Plus” include, but are not limited to the following:
 
Megajex
  • “Increase Stamina”
Casanova Plus
  • “Free From Premature Ejaculation”
Your “Megajex” and “Casanova Plus” products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because these products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the 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 application approved by FDA under either section 505(b) or (j) of the FDCA [21 U.S.C. § 355(b) or (j)] is in effect for it. There is no FDA-approved application on file for “Megajex” or “Casanova Plus.” The distribution or sale of these products without an approved application violates these provisions of the Act.
 
Misbranded Drug
 
“Megajex” contains two PDE-5 inhibitors. All PDE-5 inhibitors that have been approved for marketing by FDA are limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drugs. Therefore, “Megajex” is prescription drug as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or potentiality for harmful effect, the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs.
 
As such, “Megajex”is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because its labeling fails to bear adequate directions for its intended uses. “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. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115]. Because no FDA-approved applications are in effect for your product, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
 
Under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. According to section 201(n) of the Act [21 U.S.C. § 321(n)], in determining whether the labeling or advertising “is misleading, there shall be taken into account (among other things) not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations . . ..” The labeling for your “Megajex” fails to declare that the product contains the PDE-5 inhibitors listed in the table above. The use of PDE-5 inhibitors can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE-5 inhibitors in your product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. The failure to disclose the presence of the PDE-5 inhibitors renders your product’s labeling false or misleading. Therefore, “Megajex” is misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)]. 
 
The undeclared PDE-5 inhibitors in “Megajex” also cause this product to be misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that the product’s labeling lacks adequate warnings for the protection of users.  As previously noted, there is potential for adverse events associated with the use of PDE-5 inhibitors. Consumers who use “Megajex” would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events. 
 
Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded drug product mentioned above violates section 301(a) of the FDCA [21 U.S.C. § 331(a)].
 
A full list of all tainted products discovered by FDA can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder.   
 
Adulterated Dietary Supplements
 
Our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products, including “Vitamin C 1000 MG,” “Glucosamine Sulfate,” and “Ginkgo Biloba” products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your “Casanova Plus” product did not have therapeutic claims which make it an unapproved new drug, “Casanova Plus” would be an adulterated dietary supplement under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below. 
 
The major deviations documented during the inspection include, but are not limited to, the following:
 
1.    You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you have not established identity, purity, strength, and composition specifications and limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement for each of the components you use to manufacture your finished dietary supplement products.
 
We note that once you have established component specifications, you must determine whether those specifications are met in accordance with 21 CFR 111.75. Before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing, and you must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).
 
2.    You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you have not established finished product specifications for any of the dietary supplement products you manufacture.
 
We note that once you have established finished product specifications for dietary supplement products you manufacture, you must determine whether the specifications have been met as required by 21 CFR 111.75(c). We also note that you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
 
3.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you did not have any written procedures for quality control operations for the dietary supplements you manufacture.
 
4.    Your failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, there are no MMRs for any of the dietary supplements manufactured by your firm. We note that a MMR for each unique formulation of a dietary supplement must include the information specified in 21 CFR 111.210.
 
5.    You failed to prepare a batch production record every time you manufactured a batch of dietary supplement products, as required by 21 CFR 111.255(a). Specifically, you did not prepare batch production records for any of the dietary supplement products you manufacture.
 
6.    You failed to follow written procedures for fulfilling the requirements for components of dietary supplements as required by 21 CFR 111.153. Specifically, during the inspection it was observed that you did not identify each lot of components received in a manner that allows the traceability of the lots from the supplier, the date received, the name of the component, the status of the component and the dietary supplement that you manufactured and distributed as required by 21 CFR 111.155(d)(1).
 
7.    You failed to establish and follow written procedures for manufacturing operations, as required by 21 CFR 111.353. Specifically, you failed to establish written procedures for manufacturing operations. We note that the requirements for manufacturing operations are specified in 21 CFR 111.355, 111.360, 111.365, and 111.370. Once you have established written procedures for your manufacturing operations, you must make and keep records of these written procedures, as required by 21 CFR 111.375.
 
8.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations.
 
9.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553.  Specifically, you have no written procedures for the review and investigation of product complaints, nor do you have records documenting the complaints you have received, your response, or any investigation which may have been performed. Once you establish the necessary written procedures, you must make and keep records for the review and investigation of product complaints, in accordance with 21 CFR 111.570.
 
Misbranding Dietary Supplements 
 
During our inspection, we reviewed the labeling of your dietary supplement products, including “Vitamin C 1000 MG,” “Glucosamine Sulfate,” and “Ginkgo Biloba” products and determined that these products are misbranded foods under section 403 of the Act (21 U.S.C. § 343) in that the labels for these products do not comply with the labeling requirements in 21 CFR 101. Additionally, even if your “Casanova Plus” product did not have therapeutic claims which make it an unapproved new drug, “Casanova Plus” would be misbranded under section 403 of the Act [21 U.S.C. § 343] for the reasons described below:
 
1.    Your Vitamin C 1000 MG, Glucosamine Sulfate, Ginko Biloba, and Casanova Plus products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
 
2.    Your Casanova Plus product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. §34(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b), 21 CFR 101.36(b)(1), and 21 CFR 101.12(b), Table 2. Specifically, the direction for use for the Casanova Plus product suggests adults take two (2) tablets twice daily but the serving size for the product lists one (1) tablet.
 
3.    Your Casanova Plus product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to include a statement of identity as a “dietary supplement,” as required by 21 CFR 101.3(g).
 
4.    Your Glucosamine Sulfate and Casanova Plus products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:    
                                                                                    
o   The Glucosamine Sulfate product label declares the dietary ingredient 2KCl, but this is not the common or usual name for the dietary ingredient.
o   The Casanova Plus product label declares the dietary ingredients, horny goat weed and tongkat ali. These are not standardized common names as noted in the reference Herbs of Commerce. Because the tongkat ali botanical ingredient does not appear in Herbs of Commerce, that dietary ingredient name must include the Latin binomial in accordance with 21 CFR 101.4(h)(2).
 
5.    Your Vitamin C, Glucosamine Sulfate, and Ginkgo Biloba products are misbranded within the meaning of 403(r)(2)(A) of the Act [21 U.S.C. § 343 (r)(2)(A)] because the label makes a claim stating the absence of a nutrient which is not in accordance with 21 CFR 101.13(e)(2). For example, your label claims “no sugar” and “sodium free” but does not indicate these dietary ingredients are not normally found in that type of product.
 
6.    Your Ginkgo Biloba and Casanova Plus products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
 
The issues and violation 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 as well as the occurrence of other violations. It is your responsibility to ensure that your firm, and any drug or dietary supplement product manufactured or distributed by you or your firm, comply with all requirements of federal law and FDA regulations.
 
We offer the additional comments:
 
1.    Your Casanova Plus product label bears the statement, “* Daily Value not established,” but the asterisk does not refer to any dietary ingredient. 
2.    The presentation of the nutrition information on the labeling of your Vitamin C, Glucosamine Sulfate, and Ginkgo Biloba products is not in accordance with 21 CFR 101.36. Specifically, the title, “Supplement Facts,” is required to be set in a type size larger than all other print size in the nutrition label and shall be set the full width of the nutrition label. The nutrition information shall be enclosed in a box by using hairlines. 
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are doing to correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
FDA acknowledges that you initiated a voluntary nationwide recall of all lots of “Mejajex” on November 29, 2016.
 
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B))For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Please send your reply to:
 
Daniel Solis, Director Import Operations Branch
U.S. Food & Drug Administration
One World Trade Center, Suite 300
Long Beach, CA 90831
 
If you have questions regarding this letter, please contact Deborah Park, Compliance Officer at (562) 256-9212. Include Special Identifier FEI #3010219465 on all correspondence.
 
Sincerely,
/S/ 
CDR Steven E. Porter Jr.
Los Angeles District Director
 
 
 
Cc:     
David M. Mazzera, Chief
Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413

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