Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
December 11, 2015
The One Minute Miracle, Inc.
Attn: Rene Castillo
3322 NE 166th St
North Miami Beach, FL 33160
Dear Mr. Castillo,
The U.S. Food and Drug Administration (FDA) conducted an inspection at your firm located at 3322 NE 166th Street, North Miami Beach, FL 33160, in August 2015. We have also reviewed your website, www.theoneminutemiracleinc.com. Based on our review, FDA has determined that you offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, FDA has determined that certain products you offer for sale, including but not limited to “Miracle Diet 30” and “Miracle Rock 48,” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(a)] and misbranded drugs under section 502 and/or 503 of the Act [21 U.S.C. §§ 352 and/or 353] as detailed below.
Unapproved New Drugs
FDA confirmed through laboratory analyses that Miracle Diet 30 contains undeclared phenolphthalein. Phenolphthalein is a known carcinogen that was once an ingredient used in over-the-counter laxatives but is no longer approved for marketing in the United States. In addition, laboratory analysis by FDA concluded that Miracle Rock 48 contains thiosildenafil, a phosphodiesterase type-5 (PDE-5) inhibitor and analog of sildenafil. Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved drug for the treatment of erectile dysfunction (ED).
Miracle Diet 30 and Miracle Rock 48 are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body and, thus, are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)].
Labeling statements documenting these intended uses include, but are not limited to, the following:
Miracle Diet 30
- “Lose Weight”
- “Supports Appetite Control”
Miracle Rock 48
- “MALE SEXUAL ENHANCEMENT”
- “Unlike other sexual enhancement supplements, Miracle Rock 48 is designed to keep working in your system for up to 2 days.”
- “Customer Review: . . . for an almost 72 year old with ED . . . [n]othing works perfectly to restore me to my youthful days, but your product sure gets me a lot closer.”
Under section 201(g)(1) of the FD&C Act (last sentence), the structure/functions claims permitted for dietary supplements must be made in accordance with section 403(r)(6) of the FD&C Act [21 U.S.C. §343(r)(6)]. However, the structure/function claims made for Miracle Diet 30 and Miracle Rock 48 do not conform to section 403(r)(6). Therefore, the products are 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. The weight loss and male enhancement structure/function claims made for Miracle Diet 30 and Miracle Rock 48 do not describe the effects of a nutrient or dietary ingredient in the products. Rather, the structure/function claims made for Miracle Diet 30 and Miracle Rock 48 relate to its phenolphthalein and thiosildenafil content, respectively. Phenolphthalein and thiosildenafil are not nutrients or dietary ingredients, as defined in section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)]. For these reasons, Miracle Diet 30 and Miracle Rock 48 are drugs within the meaning of section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)].
Miracle Diet 30 and Miracle Rock 48 are 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 FDA-approved application is in effect for it.
Miracle Rock 48 is a prescription drug 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 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 it. Miracle Rock 48 is a prescription drug because it contains thiosildenafil, a PDE-5 inhibitor; 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.
Your Miracle Rock 48 product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for this drug fails to bear adequate directions for use. “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. As such, the labeling of Miracle Rock 48 fails to bear adequate directions for its intended uses. Miracle Rock 48 is not exempt from the requirement that its labeling bear adequate directions for use under 21 C.F.R. §§ 201.100(c)(2) and 201.115 because no FDA-approved application is in effect for this product.
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 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 . . .” Your products, Miracle Diet 30 and Miracle Rock 48 are misbranded under section 502(a) of the Act because their labeling makes false and misleading statements regarding safety and fails to reveal their phenolphthalein and thiosildenafil (PDE-5 inhibitor) content, which are material facts with respect to consequences that may result from the use of these products. Phenolphthalein and thiosildenafil may pose health risks to consumers which are only compounded by the fact that neither ingredient is declared on the label.
The introduction or delivery for introduction into interstate commerce of a misbranded drug product is a prohibited act under section 301(a) of the FD&C Act [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_cder1.
The issues and violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
We acknowledge your voluntary withdrawal from the marketplace all sizes and lots of the following products: Miracle Cholesterol, Miracle Night Time, Miracle Joint-Flex, Miracle Stud 72, Miracle Magic Man, Male Mint Gum, Miracle 48 Hours, Miracle Magic Woman, Miracle Cougar, Miracle Cougar Gum, Miracle Cougar G-Spot, Miracle G-Spot, Vagina Rejuvenation, Miracle Anti-Wrinkle, Miracle Stud Delay, Miracle Male Stud Spray, Miracle Male Stud Coffee, Miracle Male Coffee, Male 10, Miracle Male Stud Sublingual, Male 72 Hr, Miracle Tongue Sublingual, Miracle Tongue and Master Blaster.
We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the products you offer for sale and the claims you make for your products do not cause them to violate the Act.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete all corrections before you respond, you should explain the reason for the delay and include a timetable for the implementation of any remaining corrections.Please send your written response to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions with regard to this letter, please contact Randall L. Morris at (407) 475-4741 or email Randall.email@example.com.
Susan M. Turcovski
Director, Florida District