Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm352042.htm
Timestamp: 2019-04-19 08:47:02+00:00

Document:
This letter concerns your firm’s marketing and sale of the following products on your website, www.alternative-health-supplements.com: “Regenerect,” “Alligin,” “Astaxanthin,” “HDL Cholesterol Management,” “Coral Calcium Supreme,” “Resveratrol,” “Shark Liver Oil,” “Blood Sugar Imbalance,” and “Supreme Immune Booster.” These products are marketed and sold in violation of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
Your firm’s product “Regenerect” is an unapproved and misbranded new drug under the Act.
The claims listed above make clear that “Regenerect” is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body. These claims cause your product to be a drug, as defined in section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)].
You firm appears to market “Regenerect” as a dietary supplement because the product label includes the term “Supplement.” However, laboratory analysis conducted by the U.S. Food and Drug Administration (FDA) concluded that the “Regenerect” sold on your website contains tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Cialis, an FDA-approved drug for the treatment of erectile dysfunction (ED). Under section 201(ff)(3)(B) [21 U.S.C. § 321(ff)(3)(B)], dietary supplements may not include an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Cialis as a new drug on November 21, 2003. FDA is not aware of any tadalafil-containing products that were marketed as dietary supplements or foods before this date. As such, “Regenerect” is excluded from the definition of a dietary supplement.
Moreover, “Regenerect” is a new drug, as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its 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 “Regenerect” without such an approved application violates these provisions of the Act.
Furthermore, “Regenerect” is a “prescription drug” as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary for its use, “Regenerect” is not safe for use except under the supervision of a practitioner licensed by law to administer it. As explained above, “Regenerect” contains tadalafil, 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 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 § 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 is no FDA-approved application for your firm’s “Regenerect,” its labeling fails to bear adequate directions for its intended use, causing it 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 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 of “Regenerect” does not declare that it contains the PDE-5 inhibitor, tadalafil. The use of PDE-5 inhibitors, like tadalafil, can be associated with significant safety issues and the risk of serious adverse events. The undeclared tadalafil in “Regenerect” may pose serious health risks because consumers with underlying medical issues may take the 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. The failure to disclose the presence of tadalafil renders your product’s labeling false and misleading. “Regenerect” is, therefore, misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)].
Your product “Regenerect” is also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] because 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 “Regenerect,” particularly since someone who takes it would be unaware of the presence of the PDE-5 inhibitor, tadalafil. For example, patients who take nitrates and consume “Regenerect” may be at risk of life-threatening hypotension. Consequently, your product, “Regenerect,” is misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)].
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)].
Your firm’s products, “Alligin,” “Astaxanthin Advantage,” “HDL Cholesterol Management,” “Coral Calcium Supreme,” “Resveratrol,” “Shark Liver Oil,” “Blood Sugar Imbalance,” and “Supreme Immune Booster,” are unapproved and misbranded new drugs under the Act.
The statements listed above make clear that your products are each intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The claims cause your products to be drugs as defined by section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Furthermore, your products are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling, and therefore, are new drugs as defined by section 201(p) of the Act [21 U.S.C. § 321(p)]. 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. FDA-approved applications are not in effect for your firm’s above-listed products. Thus, the introduction or delivery for introduction into interstate commerce of the above-listed products violates these provisions of the Act.
Furthermore, your products are offered for conditions, such as cancer, diabetes, and neurodegenerative diseases, that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products, “Alligin,” “Astaxanthin Advantage,” “HDL Cholesterol Management,” “Coral Calcium Supreme,” “Resveratrol,” “Shark Liver Oil,” “Blood Sugar Imbalance,” and “Supreme Immune Booster” fail 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)]. These products are not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that their labeling bear adequate directions for use because these products lack approved applications. 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)].
In addition to the above-listed violations, we wish to alert you to the fact that there is at least one product marketed as a dietary supplement and offered for sale on your website, “Boost Ultra,” that has been the subject of an FDA public notification because laboratory analyses conducted by FDA revealed the presence of undeclared PDE-5 inhibitors.
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 assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to ensure that you have knowledge of the ingredients in your products before you offer them for sale.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. In addition, please provide evidence of the current status of the embargoed products and any necessary supporting documentary evidence. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Please send your reply to the attention of CDR Kimberly Martin, Compliance Officer, Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207-4291. If you have any questions regarding any issue in this letter, please contact CDR Martin at 317-226-6500 extension 116.

References: § 321
 § 321
 § 321
 § 353
 § 352
 § 201
 § 352
 § 352
 § 321
 § 352
 § 352
 § 352
 § 331
 § 321
 § 321
 § 352
 § 331