Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm349071.htm
Timestamp: 2019-04-23 22:39:54+00:00

Document:
From May 22 through June 1, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of the facility located at MM52 Oceanside, 9121 Overseas Highway, Marathon, FL 33050. During the inspection, FDA investigators collected samples and labeling for several of your products. Based on our review, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act). Our investigators’ observations were noted on a Form FDA-483, Inspectional Observations, which was issued to you on June 1, 2012.
You may find the Act and related regulations through links in the FDA’s home page at www.fda.gov.
Your firm’s products “X-ROCK All Natural for Men,” “Z-ROCK All Natural,” X-ROCK All Natural 3 Day Pill For Men,” and “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill” are unapproved new drugs in violation of section 505(a) and 301(d) of the Act [21 U.S.C. §§ 355(a) and 331(d)], and misbranded drugs in violation of sections 502(f)(1), (2) and 502(a) [21 U.S.C. §§ 352(f)(1), (2) and 352(a)].
Under sections 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(B) and (C)], a drug is defined as an article intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or an article (other than food) intended to affect the structure or function of the body. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. 21 C.F.R. Part 201.128.
The claims on your products’ labels, including the product names, and the presence of various PDE-5 inhibitors, such as tadalafil, sildenafil, hydroxythiohomosildenafil, thiosildenafil, and/or thiodimethyl sildenafil, in the above-listed products, indicate that these products are intended to affect the structure or function of the body or for use as a treatment for erectile dysfunction (ED).
“X-ROCK All Natural For Men,” “Z-ROCK All Natural,” “X-ROCK All Natural 3 Day Pill For Men,” and “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill” are drugs as defined by sections 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)].
Moreover, these products are new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they 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 FDA-approved application is in effect for it. Accordingly, the introduction or delivery for introduction into interstate commerce of “X-ROCK All Natural For Men,” “Z-ROCK All Natural,” “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill,” and “X-ROCK All Natural 3 Day Pill For Men,” or the causing thereof, without approved applications, violates these provisions of the Act.
“X-ROCK All Natural For Men,” “Z-ROCK All Natural,” “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill,” and “X-ROCK All Natural 3 Day Pill For Men” products 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 potentially harmful effect, the method 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. Indeed, 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 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 CFR. Part 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 there are no FDA-approved applications for your firm’s “X-ROCK All Natural For Men,” “Z-ROCK All Natural,” “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill,” and “X-ROCK All Natural 3 Day Pill For Men” products, their labeling fails to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
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 labeling for your products, “X-ROCK All Natural For Men,” “Z-ROCK All Natural,” “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill,” and “X-ROCK All Natural 3 Day Pill For Men” does not declare that the products contain the PDE-5 inhibitors listed in the table above. The use of PDE-5 inhibitors, like sildenafil and tadalafil, can be associated with significant safety issues and the risk of serious adverse events. The undeclared PDE-5 inhibitors in your products 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 to the PDE-5 inhibitors listed in the table above renders your products’ labeling false or misleading. Therefore, “X-ROCK All Natural For Men,” “Z-ROCK All Natural,” “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill,” and “X-ROCK All Natural 3 Day Pill For Men” are misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)].
Your “X-ROCK All Natural For Men,” “Z-ROCK All Natural,” “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill,” and “X-ROCK All Natural 3 Day Pill For Men” products are also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] in that the products’ labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of these products, particularly since someone who takes one of these products would be unaware of the presence of the PDE-5 inhibitors listed in the table above. For example, patients who take nitrates and consume one of these products may be at risk of life-threatening hypotension.
The introduction or delivery for introduction into interstate commerce of these misbranded products, or the causing thereof, violates section 301(a) of the Act [21 U.S.C. § 331(a)].
In addition, we note that to the extent your firm manufactures, packages, labels, or holds dietary supplements, as defined in section 201(ff) of the Act [21 U.S.C. § 321(ff)], you are required to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements at 21 CFR Part 111, as applicable. Such regulations include, but are not limited to, the requirement to implement quality control operations [21 C.F.R. Part 111.65]; the requirement to implement a system of production and process controls [21 C.F.R. Part 111.55]; the requirement to establish specifications, including specifications for packaging and labeling [21 C.F.R. Part 111.70]; the requirement to establish written procedures relating to the review and investigation of product complaints [21 C.F.R. Part 111.553]; and the requirement to make and keep written procedures for returned dietary supplements [21 C.F.R. Part 111.535]. Dietary supplements that have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements at 21 CFR Part 111 are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Further, the introduction or delivery for introduction into interstate commerce, or causing thereof, of an adulterated dietary supplement is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)].
Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Your response should include an explanation of each step being taken to correct the violations listed above and to prevent the recurrence of such violations in the future. Your response should also describe the current status of the product recalls for “X-ROCK All Natural For Men”, “Z-ROCK All Natural”, “X-ROCK for ERECTILE REFUNCTION The (3) Day Pill”, and “X-ROCK All Natural 3 Day Pill For Men,” and the current disposition of the recalled products. Further, your response should include any documentation necessary to assist us in evaluating your corrections. If you cannot complete corrective actions within fifteen (15) working days, you should explain the reason for your delay and state the time within which you will complete the correction. If you no longer market these products, please indicate this in your response, including the reasons and the date on which you ceased to market them.
Please send your response to the attention of Andrea H. Norwood, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, you may contact Ms. Norwood via telephone at (407) 475-4724 or via email at Andrea.Norwood@fda.hhs.gov.
 Your firm appears to market “X-ROCK All Natural for Men,” “Z-ROCK All Natural,” and “X-ROCK All Natural 3 Day Pill for Men” as dietary supplements because the product labels include the term “Supplement.” However, as noted above, all three products contain sildenafil, the active ingredient in Viagra (an FDA-approved drug for ED), and “X-ROCK All Natural 3 Day Pill for Men” also contains tadalafil, the active ingredient in Cialis (also an FDA-approved drug for ED). Under Section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)], dietary supplements may not include articles approved as a new drug under Section 505 of the Act, unless the article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Viagra as a new drug on March 27, 1998, and approved Cialis as a new drug on November 21, 2003. FDA is not aware of any sildenafil- or tadalafil-containing products that were marketed as dietary supplements or foods before these respective dates. As such, “X-ROCK All Natural For Men,” “Z-ROCK All Natural,” and “X-ROCK All Natural 3 Day Pill For Men” are excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)].
 Because hydroxythiohomosildenafil, thiosildenafil, and thiodimethyl sildenafil are analogues of sildenafil, they likely exhibit the same pharmacological action to sildenafil.

References: § 321
 § 321
 § 353
 § 352
 § 352
 § 352
 § 321
 § 352
 § 352
 § 331
 § 321
 § 342
 § 331
 § 321
 § 321