| Public Health Service Food and Drug Administration |
| 555 Winderley Pl., Ste. 200 Maitland, FL 32751 |
Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-10-23
June 4, 2010
Gustavo Bami
President/Owner
Atlas Operations, Inc.
325 Sw 15th Ave
Pompano Beach, FL 33069-3246
Dear Mr. Barni,
The United States Food and Drug Administration (FDA) conducted an inspection of your facility at the address referenced above from October 28,2009 through November 16, 2009. During the inspection, our FDA investigator also collected samples of your Aspire One ingredient and products that contained this ingredient including, but not limited to, Rock Hard Weekend, 72 Hours, Stamin It, Finally On Demand, Staminil, and Vierect. Laboratory analyses conducted by the FDA concluded that these products contain sulfoaildenafil, an analogue of sildenafil, the active pharmaceutical ingredient in Viagra, an FDA-approved drug used to treat erectile dysfunction (ED). The inspection revealed your firm is marketing unapproved drugs in violation of section 505(a) of the Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 355(a)) and misbranded drugs in violation of sections 502(f)(1) (21 U.S.C. § 352(f)(1)), 502(f)(2) (21 U.S.C. § 352(f)(2)) and 502(a) (21 U.S.C. § 352(a)). The inspection also revealed serious deficiencies from the current Good Manufacturing Practice (cGMP), 21 CFR Part 111 Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements which causes your products to be adulterated under Section 402(g)(1) (21 U.S.C. § 342(g)(1)) ofthe Act.
Unapproved, Misbranded, and Prescription Drugs
Your firm's products "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," "VIERECT," "On Cycle II Hardcore," "Sleep Quick Strips," "Sleep Once Again," "Sleep Ease," "Insomnix," "Musclextreme Pump Extreme," "Derma-Tropin," and "GH.X Growth Hormone Extreme" are marketed in violation of the Federal Food, Drug, and Cosmetic Act (the Act), as described below.
Sexual Enhancement and Body Building Products
Your firm's sexual enhancement or body building products "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," "VIERECT," and "On Cycle II Hardcore" are unapproved and misbranded drugs under the Act.
Your sexual enhancement and body building products are labeled with claims such as the following:
Rock Hard Weekend
• "The 72 Hour Sexual Performance Pill for Men"
72 HOURS
• "THE ULTIMATE MALE ENHANCEMENT FORMULA"
• "72 HOURS" superimposed on the male symbol "6"
STAMIN IT
• "Sexual Enhancer for Men" in close proximity to the male symbol "6"
Finally On DEMAND
• "May Help Maintain Normal Erectile Quality and Support Sexual Performance"
• "May Help Support Normal Arousal, and Support Stimulation and Stamina"
STAMINIL
• "INTENSE PLEASURE FORMULA"
• "Male Sexual Enhancement"
VIERECT
• "Power - Performance - Persistence"
• "ENHANCER FOR MEN"
On Cycle II Hardcore
• "On Cycle" and "If you are subject to performance enhancing drug testing, do not use this product unless cleared by your sanctioning body."
The statements above make clear that "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," "VIERECT," and "On Cycle II Hardcore" are intended to affect the structure or function of the human body. Accordingly, these products are drugs under 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)).
Your firm's "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT" sexual enhancement products are labeled as dietary supplements. However these products contain the " proprietary blend" "Aspire One," which your firm imports from (b)(4) Samples of "Aspire One" and the above mentioned sexual enhancement products were collected at your facility on October 28-29, 2009 and found to contain sulfoaildenafil, a phosphodiesterase type 5 (PDE5) inhibitor and an analogue of sildenafil. Sildenafil is the active pharmaceutical ingredient in Viagra, which is an FDA-approved prescription drug used to treat ED. Sulfoaildenafil is a synthetic active pharmaceutical ingredient and is not a dietary ingredient as defined in section 201(ff)(1) of the Act (21 U.S.C. § 321(ff)(1)).
The label of your bodybuilding product "On Cycle II Hardcore" states that the product is a dietary supplement, and states that the product contains the synthetic anabolic steroid 2a, 17a-dimethyl-etiocholan 3-one, 17b-ol. This synthetic anabolic steroid ingredient is not a dietary ingredient as defined in section 201(ff)(1) of the Act (21 U.S.C. § 321(ff)(1)).
Under section 201(g)(1) (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with section 403(r)(6) of the 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 claims quoted above for "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT" do not describe the effects of nutrients or dietary ingredients in the products. Rather, the claims for each product are made for the product as a whole and relate to the sulfoaildenafil content. Since sulfoaildenafil is not a nutrient or dietary ingredient but a synthetic active pharmaceutical ingredient, claims about improvement of sexual function do not conform to section 403(r)(6) of the Act (21 U.S.C. § 343(r)(6)). Accordingly, the claims for "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT" render them drugs within the meaning of section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)).
Similarly, the claim quoted above for your body building product "On Cycle II Hardcore" does not describe the effects of nutrients or dietary ingredients in the product. Rather, this claim is made for the product as a whole and relates to its synthetic anabolic steroid content. Because 2a, 17a-dimethyl-etiocholan 3-one, 17b-ol is not a nutrient or dietary ingredient but a synthetic anabolic steroid, claims about improvement of the structure or function of the body do not conform to section 403(r)(6) of the Act. Accordingly, the claim for your product "On Cycle II Hardcore" renders it a drug within the meaning of section 201(g)(1)(C) of the Act (21 U.S.C. § (g)(1)(C)).
Moreover, the above listed sexual enhancement and body building products are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(P)), because they 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 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 sale of "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," "VIERECT," and "On Cycle II Hardcore" without approved applications violates these provisions of the Act.
"ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," "VIERECT," and "On Cycle II Hardcore" are prescription drugs as defined in section 503(b)(1)(A) of the Act (21 U.S.C. § 353(b)(1)(A)), because, in light of their toxicity or other potentiality for harmful effect, the method 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 them. Indeed, all PDE 5 inhibitors and all anabolic steroids which have been approved for marketing by the 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.
According to section 502(f)(1) of the 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 C.F.R. § 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 requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 201.100(c)(2) and 201.115). Because there are no FDA approved applications for your firm's "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," "VIERECT," and "On Cycle II Hardcore," their labeling fails to bear adequate directions for their intended uses, causing them to be 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 these misbranded products violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Additionally, 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. Section 201(n) of the Act (21 U.S.C. § 321(n)) provides that, in determining whether a drug'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 labels of "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT" do not declare that the products contain sulfoaildenafil. Sulfoaildenafil is an analogue of sildenafil, and, like sildenafil, is a PDE5 inhibitor. Because it is an analogue of sildenafil, it likely exhibits similar pharmacological action to sildenafil. The use ofPDE5 inhibitors, like sildenafil, can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE5 inhibitors in the products listed above may pose serious health risks because patients with underlying medical issues may take these products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE5 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, high cholesterol, or heart disease often take nitrates. Further, patients that have been advised against taking PDE5 inhibitors because of comorbidities or potential drug interactions may seek products like "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT" because the products are marketed as "natural" or as not containing the active ingredients in approved ED drugs.. The failure to disclose the presence of sulfoaildenafil renders the products' labeling false and misleading. "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT" are therefore misbranded under Section 502(a) of the Act, 21 U.S.C. § 352(a), and the introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act (21 U.S.C. § 331(a)).
"ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT" are also misbranded under Section 502(f)(2) of the Act, (21 U.S.C. § 352(f)(2)) in that their labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," and "VIERECT," particularly since someone who takes one of these products would be unaware of the presence of sulfoaildenafil. For example, because sulfoaildenafil is an analogue of sildenafil and is a PDE5 inhibitor, patients who take nitrates and consume "ROCK HARD WEEKEND," "72 HOURS," "STAMIN IT," "Finally On DEMAND," "STAMINIL," or "VIERECT" may be at risk of life-threatening hypotension. The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Thin Strip and Topical Products
Your firm's thin strip and topical products "Sleep Quick Strips," "Sleep Once Again," "Sleep Ease," "Insomnix," "Musclextreme Pump Extreme," "Derma-Tropin," and "GH.X Growth Hormone Extreme" are unapproved drugs under the Act.
Your thin strip and topical products are labeled with claims such as the following:
Sleep Quick Strips
• "NATURAL SLEEP AID" and a photograph depicting a woman asleep.
Sleep Once Again
• "NATURAL SLEEP AID" and a photograph depicting a woman asleep.
Sleep Ease:
• "NATURAL SLEEP AID" and a photograph depicting a woman asleep.
Insomnix
• "NATURAL SLEEP AID" and a photograph depicting a woman and man asleep.
Musclextreme Pump Extreme
• "Musclextreme Pump Extreme" used In conjunction with "Apply on areas to be trained..."
Derma-Tropin
• "hGH"; hGH is the abbreviation for human growth hormone.
GH.X Growth Hormone Extreme:
• "IGF-1 INDUCER"; IGF-1 is the abbreviation for insulin-like growth factor-I.
Under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)) products (other than foods) that are intended to affect the structure or function of the body are defined as drugs. The claims listed above make clear that your products, "Sleep Quick Strips," "Sleep Once Again," "Sleep Ease," "Insomnix," "Musclextreme Pump Extreme," "Derma-Tropin," and "GH.X Growth Hormone Extreme" are intended to affect the structure or function of the human body. Your firm markets these products as dietary supplements. However, the Act defines the term "dietary supplement" in section 201(ff)(2)(A)(i) of the Act (21 U.S.C. § 321(ff)(2)(A)(i)), as a product that is "intended for ingestion." Because topical products and products such as your thin strip products are intended to enter the body directly through the skin or mucosal tissues, they are not dietary supplements or foods. Therefore, the above-mentioned products are drugs under section 201 (g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)).
Moreover, "Sleep Quick Strips," "Sleep Once Again," "Sleep Ease," "Insomnix," "Musclextreme Pump Extreme," "Derma-Tropin," and "GH.X Growth Hormone Extreme" are "new drugs," as defined by section 201(P) of the Act (21 U.S.C. § 321(p)), because they 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 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 sale of "Sleep Quick Strips," "Sleep Once Again," "Sleep Ease," "Insomnix," "Musclextreme Pump Extreme," "Derma-Tropin," and "GH.X Growth Hormone Extreme" without approved applications violates these provisions of the Act.
Additionally, 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. Section 201(n) of the Act (21 U.S.C. § 321(n)) provides that, in determining whether a drug'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 "Derma-Tropin" contains the term "hGH," the abbreviation for human growth hormone, on the front of the label. Section 303(e)(4) of the Act (21 U.S.C. § 333(e)(4)) defines human growth hormone as somatrem, somatropin, or an analogue of either of them. However, the "Supplement Facts" panel on Derma-Tropin's label does not list somatrem, somatropin, or an analogue of either of them as an ingredient in the product. Accordingly, Derma-Tropin's labeling is misleading because the front of the labeling suggests that the product contains hGH, while the "Supplement Facts" panel indicates that the product does not contain hGH. DermaTropin is therefore misbranded under section 502(a) of the Act (21 U.S.C. § 352(a)), and the introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Moreover, under 21 CFR 310.530(b), any over-the-counter drug product that is labeled, represented, or promoted as a topically applied hormone-containing product for drug use, such as your firm's Derma-Tropin product, is regarded as a new drug within the meaning of section 201(P) of the Act (21 U.S.C. § 321(P)), and is misbranded under section 502 of the Act (21 U.S.C. § 352) unless an FDA-approved application is effect for it. Therefore, your sale of Derma-Tropin without an approved application renders it misbranded under section 502 of the Act, and the introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Adulterated Dietary Supplements
The inspection revealed that the products manufactured in your facility are adulterated within the meaning of Section 402(g)(1) [21 U.S.C. 342(g)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that the dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements. These observations were presented to you on an FDA-483 at the conclusion of our inspection on November 16, 2009.
Your significant observations cited under 21 CFR Part 111 by our investigator are as follows:
Your firm's batch production records do not include the unique identifier that you assigned to each component, as required by 21 CFR 111.260(d). Specifically, a review of your batch records revealed a lack of a unique identifier listed for the following components:
• Rehmannia Root Powder, listed as a component in Sexual Enhancer, Batch #B4-779-09.
• Rehmannia Root Powder and Lycium, listed as components in Erousa, Batch #T34-705-09; and
• Saffron Crocus, 2-DG (2-Deoxyglucose), and Wolfberry, listed as components III WhatzUp, Batch #R28-09.
Your firm failed to make and keep documentation of the controls you use to ensure that equipment functions in accordance with its intended use, as required by 21 CFR 111.35(b)(6). Specifically, your firm did not have documentation showing that the air compressing hose and sieve you used to remove excess product residue from the Saw Palmetto Extract capsules function in accordance with this purpose.
Your firm failed to make and keep documentation of calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(3). Specifically, you did not have records of calibration for the scale used to weigh raw ingredients in the formulation room.
Your firm failed to include the following required information in the master manufacturing record for formulas:
• For formulas (b)(4) and (b)(4) a statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
• For formulas (b)(4) a description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]; and
• For formulas (b)(4) written instructions, including procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
These deviations from the CGMP requirements cause your dietary supplement products to be adulterated under Section 402(g)(1) of the Act.
We acknowledge your verbal agreement with and your voluntary corrections communicated to our investigator to the observations listed on the FDA 483, dated November 16, 2009. We will evaluate the adequacy of these corrections during our next inspection.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to assure that your products are in compliance with all applicable laws and regulations. You should act quickly to correct the regulatory deviations noted in this letter. Failure to correct may result in regulatory action without further notice, such as seizure and/or injunction.
In addition to the above violations, we also have several comments.
Your quality control personnel did not approve the use of ingredients for which the expiration date had passed. Quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplements, including approving all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them that may affect the identity, purity, strength, or composition of the dietary supplement (21 CFR 111.105(a)). Specifically, a review of certificates of analysis and batch records found you used several expired dietary supplement components during production. For example:
• (b)(4) was used in the production of Saw Palmetto Extract, Formula (b)(4) The certificate of analysis from the ingredient supplier (b)(4) showed an expiration date of 6/04/2009.
• (b)(4) was used in the production of CoQ10, Formula (b)(4) The certificate of analysis from the ingredient supplier (b)(4) showed an expiration date of 06/04/2009.
• (b)(4) was used in the production of Rock Hard, Formula (b)(4) for Batch number (b)(4) The certificate of analysis from the ingredient supplier (b)(4) showed an expiration date of February 2008.
• (b)(4) was used in the production of Rock Hard, Formula (b)(4) for Batch number (b)(4) The certificate of analysis from the ingredient supplier (b)(4) showed an expiration date of 10/14/2008.
• (b)(4) was used in the production of Rock Hard, Formula (b)(4) for Batch number (b)(4). The certificate of analysis from the ingredient supplier (b)(4) showed an expiration date of 06/4/2009.
You must establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)], and you must determine whether specifications are met according to the requirements stated in 21 CFR 111.75. Your quality control unit has not approved your use of expired components. The use of such expired components may affect the purity, strength, or composition of your dietary supplements.
Your reserve samples of dietary supplements were not held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, as required by 21 CFR 111.465(a)(2). Your products appear to be distributed in bottles, but your reserve samples were packaged in (b)(4) stapled to retainer sheets.
Your personnel, who work in an operation during which adulteration of the component, dietary supplement, or contact surface could occur, must use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, and contact surfaces, as required by 21 CFR 111.10(b). Specifically, your personnel used gloves that were not maintained or used in a sanitary condition. On 11/03/09, an associate washed his hands and removed gloves from his pocket. He proceeded to wear the same gloves to open doors, select raw ingredients and weigh various raw ingredients in the formulation room during the production of Saw Palmetto, (b)(4)
You did not clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements, as required by 111.27(d)(4). Specifically, during the production of Saw Palmetto Extract, Batch (b)(4) on 11/30/09, your humidifier in the blending room had excess dust accumulation. You must clean the surface of the humidifier as frequently as necessary to protect components and dietary supplements from being contaminated with dust.
You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated, as required by 21 CFR 111.15(b)(2). Specifically, there were openings around the electrical pipes extending into the ceiling in your processing room. These openings may provide an entry point for pests and may accumulate filth that may cause components, dietary supplements, or contact surfaces to become contaminated.
You should respond in writing within fifteen (15) working days from your receipt of this letter. If you cannot complete all corrections before you respond, please explain the reason for your delay and provide us with a timeframe for the correction of any outstanding violations.
Please send your response to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have
questions regarding any issue in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
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