Inspections, Compliance, Enforcement, and Criminal Investigations

Calcomp Nutrition Llc 9/24/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
14-PHI-22
 
Delivered Via United Parcel Service
 
 
September 24, 2014
 
CalComp Nutrition, Inc.
Attn: John A. Simco, President
2021 Clay Pike #1
Irwin, PA 15642
 
Dear Mr. Simco:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at www.calcompnutrition.com and has determined that your products “Herbal Vigor Quick Fix” (“Herbal Vigor”) and “Arize” are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502, 503, and 301(a) of the FD&C Act [21 U.S.C. §§ 352, 353, and 331(a)], as detailed below.
 
“Herbal Vigor” and “Arize” are marketed as dietary supplements. FDA confirmed through laboratory analysis that “Herbal Vigor” contains undeclared tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor and the active pharmaceutical ingredient in Cialis, an FDA-approved drug for the treatment of erectile dysfunction (ED). According to Section 201(ff)(3)(B) [21 U.S.C. § 321(ff)(3)(B)], dietary supplements 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 such drug. FDA approved Cialis as a new drug on November 21, 2003. Tadalafil was not marketed as a dietary supplement or as food before this date. As such, “Herbal Vigor” is not considered a dietary supplement. Laboratory analysis further confirmed that your “Arize” contains undeclared sulfoaildenafil, a phosphodiesterase type-5 (PDE-5) inhibitor and analog of sildenafil, the active pharmaceutical ingredient in Viagra, another FDA approved drug used to treat ED.
 
Labeling claims for “Herbal Vigor” and “Arize” include, but are not limited to, the following: 
 
“Herbal Vigor”
 
  • “Designed To Stimulate Blood Flow.”
  • “Herbal Vigor Quick Fix will give you the confidence you need to perform every time.”
  • “[J]ust take 1 pill 30 minutes prior to sexual activity.”
 
“Arize”
 
  • “Works In Minutes And Lasts For Up to 4 Days.”
  • “AriZe works within 10 - 30 minutes for a majority of the individuals.”
  • “[Y]ou will be more-than-ready for any possible sexual encounters that might come your way... for some, even if you are currently impotent!”
  • “When we first conceptualized AriZe, we wanted a product that will not only help to channel maximum blood flow to the penis, it must also enhance the libido simultaneously.”
 
These statements make clear that “Herbal Vigor” and “Arize” 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 affect the structure or function of the human body. With respect to “Arize,” under section 201(g)(1) of the FD&C Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the FD&C Act [21 U.S.C. § 343(r)(6)], or the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. However, the structure/function claims quoted above for “Arize” do not describe the effects of nutrients or dietary ingredients in the product. Rather, the claims are made for the product as a whole and relate to its sulfoaildenafil content. Since sulfoaildenafil is not a nutrient or dietary ingredient, as defined in section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)], but a synthetic active pharmaceutical ingredient, claims about improvement of sexual function do not conform to section 403(r)(6) of the FD&C Act [21 U.S.C. § 343(r)(6)]. Accordingly, “Arize” is a drug within the meaning of section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)].
 
“Herbal Vigor” and “Arize” are also new drugs under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because these 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. No approved application is in effect for these products. Therefore, the distribution or sale of “Herbal Vigor” and “Arize” violates these provisions of the FD&C Act.
 
“Herbal Vigor” and “Arize” are prescription drugs as defined by 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 effects, the methods of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. “Herbal Vigor” and “Arize” are prescription drugs because they contain PDE-5 inhibitors; all PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer them.
 
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 be used safely only 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 there is no FDA-approved application for “Herbal Vigor” and “Arize,” their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
 
“Herbal Vigor” and “Arize” are also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] in that the products’ labeling lacks adequate warnings for the protection of users. There is a potential for adverse events associated with these products, particularly since someone who takes them would be unaware of the presence of tadalafil and sulfoaildenafil in your “Herbal Vigor” and “Arize” products respectively. The undeclared ingredients may interact with nitrates found in some prescription drugs, such.as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
 
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.” “Herbal Vigor” and “Arize” are misbranded under section 502(a) of the FD&C Act because their labeling make false and misleading statements regarding safety and fail to reveal material facts with respect to consequences that may result from the use of these products. Tadalafil and sulfoaildenafil, contained in your “Herbal Vigor” and “Arize” may pose serious health risks to consumers, which are only compounded by the fact that these ingredients are not declared on the product’s label.
 
Accordingly, the introduction or delivery for introduction into interstate commerce of the misbranded products mentioned above violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not meant to be an all-inclusive list of violations in connection with your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the FD&C Act and its implementing regulations. In particular, it is your responsibility under the FD&C Act to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law and regulations. We also advise you to review your website, your products, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the FD&C Act . In particular, we note that there appear to be numerous products marketed as dietary supplements and offered for sale on your website that have been the subject of an FDA public notification because laboratory analyses conducted by FDA revealed the presence of potentially harmful hidden ingredients.[1]
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The FD&C Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products under sections 304 and 302 of the FD&C Act [21 U.S.C. §§ 334 and 332].
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Additionally, if another firm manufactures these products identified within this letter, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name and address of your supplier in addition to the manufacturer information. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
 
Your response should be sent to Richard C. Cherry, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Mr. Cherry can be reached at 215-717-3075 or Richard.Cherry@FDA.HHS.GOV
 
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District
 
cc:       
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Acting Director


[1] 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.
 

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