- Delivery Method:
- VIA SIGNATURE CONFIRMED DELIVE
Recipient NameMr. Malek Bhairi
- Natures Rx, LLC
150 Drake Street Apt 3M
Pomona, CA 91767
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
February 21, 2020
Dear Mr. Bhairi:
This letter concerns products that your firm distributes to consumers via your website, www.naturalrx.net. The United States Food and Drug Administration (FDA) has obtained a sample and labeling of the product, “Silver Bullet”. As described below, this product is an unapproved new drug 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)]. Furthermore, the product is a misbranded drug under section 502 of the FD&C Act [21 U.S.C. § 352] and sold in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
FDA confirmed through laboratory analysis that a sample of your “Silver Bullet” contains the undeclared active pharmaceutical ingredient sildenafil, a phosphodiesterase type-5 (PDE-5) inhibitor. Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease, often take nitrates.
You market “Silver Bullet” as a dietary supplement. However, under section 201(ff)(3)(B)(i) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(i)], a dietary supplement may not include 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 before its approval as a 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, “Silver Bullet,” which contains sildenafil, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.
Unapproved New Drug
“Silver Bullet” is a drug as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] because it is intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Label statements documenting the intended uses of “Silver Bullet” include, but are not limited to, the following:
- “GET BIGGER & HARDER”
- “WORKS IN MINUTES…LASTS FOR DAYS”
Your “Silver Bullet” is also a new drug under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its 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. Your marketing and distribution of “Silver Bullet” without an approved application violates these provisions of the FD&C Act.
Your “Silver Bullet” also is misbranded under section 502(f)(1) of the FD&C 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 CFR § 201.5]. 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. 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. “Silver Bullet” is not exempt from the requirements that its labeling bear adequate directions for use by a layperson [21 U.S.C. §§ 201.100(c)(2) and 201.115], because there is no FDA approved application in effect for this product. For these reasons, “Silver Bullet” is misbranded under section 502(f)(1) of the FD&C Act.
Additionally, 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.” The labeling for “Silver Bullet” does not declare that it contains sildenafil. The failure to disclose the presence of sildenafil in the product’s labeling renders “Silver Bullet” misbranded under section 502(a) of the FD&C Act. The presence of undeclared PDE-5 inhibitors contained in your product may pose serious health risks, because consumers with underlying medical issues may take this product without knowing that it 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, high cholesterol, or heart disease often take nitrates. Those consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or potential drug interactions, may seek products like “Silver Bullet” because it is marketed as a dietary supplement.
The undeclared sildenafil in “Silver Bullet” also cause this product to be misbranded under section 502(f)(2) of the FD&C 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 “Silver Bullet” would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.
The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
The issues and violations cited 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 or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations, and to ensure that all products you manufacture or distribute are in compliance with the FD&C Act and all of its implementing regulations and all other requirements of federal law. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action of violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
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 electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506
Please identify your responses with the unique identifier: CMS 596516.
If you have questions regarding the contents of this letter, please contact Stephanie Slater, Acting Compliance Officer via email at firstname.lastname@example.org or by telephone at 562-256-9223.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV