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WARNING LETTER

Wave Miami LLC MARCS-CMS 590422 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Andres Rivera
Wave Miami LLC

1434 E. Hunting Park Avenue
Philadelphia, PA 19124
United States

Issuing Office:
Division of Pharmaceutical Quality Operations I

United States


WARNING LETTER
CMS #590422

January 13, 2020

Mr. Rivera,

This letter is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the information on your website, https://www.liprodietpill.com, and Facebook pages, https://www.facebook.com/Lipro-Diet-Pills-191157693096 and https://www.facebook.com/LiproDietPills, and determined that you market and offer a product for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, FDA has determined that the “Lipro Dietary Capsule” product you offer for sale is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)]. Furthermore, this product is a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)].

FDA confirmed through laboratory analysis that your “Lipro Dietary Capsule” contains undeclared tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. Tadalafil is the active pharmaceutical ingredient in Cialis, 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. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

FDA has issued a warning to consumers not to use “Lipro Dietary Capsule” (see Lipro Dietary Capsule Immediate Public Notification).

Although you engaged in communication with the Agency regarding a recall of “Lipro Dietary Capsule” on (b)(4), to date your firm has not voluntarily recalled the product. We continue to recommend that the product be recalled from the market.

You market “Lipro Dietary Capsule” 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 Cialis (containing tadalafil as the active ingredient) as a new drug on November 21, 2003. Given that tadalafil was not marketed as a dietary supplement or as a food before Cialis was approved, “Lipro Dietary Capsule,” which contains tadalafil, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)(i)].

Unapproved New Drug

“Lipro Dietary Capsule” 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. Statements documenting the intended uses of your product include, but are not limited to, the following:

On the product webpage, https://www.liprodietpill.com:

  • “Natural weight loss without starving.”
  • “Curbs appetite.”
  • “No crazy drugs, exercise or diet regimes”
  • “Lipro diet pills come with a high promise of effective weight lose [sic]. They promise that the user will lose up to 30 pounds in a span of 30 days.”

On the webpage, https://www.facebook.com/LiproDietPills:

  • “Best Diet Pill for rapid weight loss”
  • “Lose 15-30 pounds in one month”
  • “Natural weight loss without starving”
  • “Curbs appetite.”
  • “No crazy drugs, exercise or diet regimes”

In addition, your “Lipro Dietary Capsule,” is a new drug under section 201(p) of the FD&C Act 21 U.S.C. 321(p), because this product 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. There are no approved applications on file with FDA for your “Lipro Dietary Capsule.” Your marketing and distribution or sale of “Lipro Dietary Capsule” in interstate commerce without an approved application violates these provisions of the FD&C Act.

Misbranded Drug

Your “Lipro Dietary Capsule” product is also 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. [See 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. “Lipro Dietary Capsule” 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 such drugs; therefore adequate directions for use cannot be written so that a layperson can use your product safely. Under 21 CFR §§ 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your “Lipro Dietary Capsule” is not exempt from the requirement that its labeling bear adequate directions for use because no FDA-approved application is in effect for this product.

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 “Lipro Dietary Capsule” does not declare that it contains tadalafil. The failure to disclose the presence of tadalafil in the product’s labeling renders “Lipro Dietary Capsule” misbranded under section 502(a) of the FD&C Act. As discussed earlier, the presence of an undeclared PDE-5 inhibitor 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. Those consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or potential drug interactions may seek products like “Lipro Dietary Capsule” because it is marketed as a dietary supplement.

The undeclared tadalafil in “Lipro Dietary Capsule” also causes 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 “Lipro Dietary Capsule” would be unaware of the presence of the undeclared ingredient and unknowingly 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)].

Conclusion

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_cder.

The violations cited in this letter are not intended to be an all-inclusive list 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 marketed or distributed by your firm comply with the FD&C Act and all 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 promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.

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 corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Please send your electronic reply to orapharm1_responses@fda.hhs.gov. Your written notification should refer to the Warning Letter Number above (CMS #590422).

If you have any questions, contact Compliance Officer James Mason at james.mason@fda.hhs.gov or 570-262-0519.

Sincerely,
/S/

Diana Amador-Toro
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I/New Jersey District

 
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