DD Support Board and Research Team

[scion]

Rare FDA Warning Letter Calls Hemp-Laced Beverage a Drug

http://www.raps.org/focus-online/news/news-article-view/article/4425/rare-fda-warning-letter-calls-hemp-laced-beverage-a-drug.aspx

WARNING LETTER

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm377975.htm

Green Planet Inc 12/5/13
Department of Health and Human Services Public Health Service
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone [phone]
Fax [phone]


WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

December 5, 2013


W/L # 05-14

Mr. Anil K. Malhi, CEO
Green Planet, Inc.
7260 Sycamore Canyon Blvd.
Riverside, CA 92508-2332


Dear Mr. Malhi:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement and beverage packaging, labeling, and distribution facility, located at 7260 Sycamore Canyon Blvd., Riverside, California from January 17 through February 06, 2013. FDA collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. Based on our review of your product labels, we have determined that your products, Night Bullet Male Sexual Enhancer Capsules and Hemp Garden Tea are promoted for conditions that cause them to be drugs. Your firm's marketing and distribution of these products violate section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21. U.S.C. § 355(a)] and are misbranded under sections 502 and 301 of the FD&C Act [21 U.S.C. §§ 352 and 331].

Unapproved New Drug and Misbranded Drug

During the inspection of your facility, FDA collected samples of Night Bullet Male Sexual Enhancer Capsules (Night Bullet).1 Laboratory analysis by FDA concluded that lot # B43N032 of your product Night Bullet contains sulfohydroxyhomosildenafll and thiosildenafll, which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafll. Sildenafll is the active pharmaceutical ingredient in Viagra, also an FDA-approved drug for the treatment of erectile dysfunction (ED). In addition, laboratory analysis by FDA concluded that your product contains aminotadalafll, a phosphodiesterase type-5 (PDE-5) inhibitor and analogue of tadalafll. Tadalafll is the active pharmaceutical ingredient in Cialis, an FDA-approved drug for the treatment of erectile dysfunction (ED). Your marketing and distribution of Night Bullet violates section 505(a) of the FD&C Act [21. U.S.C. § 355(a)] and is misbranded under sections 502 and 301 of the FD&C Act [21 U.S.C. §§ 352 and 331], as described below.

Your firm's product Night Bullet is labeled as a dietary supplement. However, Night Bullet is subject to regulation as a drug, as defined by section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(l)], because it is intended to prevent, treat, or cure disease conditions and affect the structure or function of the body. Labeling statements documenting the intended use of Night Bullet, include, but are not limited to, the following:


• "Scientifically calculated to multiply your Sexual Drive and Stamina!"
• "Maximize Orgasm Duration & Intensity!"
• "Clinically proven to provide powerful Erections!"
• "Designed for Sexual Stimulation"
• "Increase Male Size and Firmness"
• "Eliminate Premature Ejaculation"


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 Night Bullet do not conform to section 403(r)(6). Therefore, the product is 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 male enhancement structure/function claims made for Night Bullet do not describe the effects of a nutrient or dietary ingredient in the product. Rather, the structure/function claims made for the product relate to its aminotadanafil, thiosildenafil and sulfohydroxyhomodildenafil content. Aminotadanafil, thiosildenafil and sulfohydroxyhomodildenafil are not nutrients or dietary ingredients, as defined in section 201(ff)(l) of the FD&C Act [21 U.S.C. § 321(ff)(1)], but are synthetic active pharmaceutical ingredients. For these reasons, Night Bullet is a drug within the meaning of section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)].

Moreover, Night Bullet is a new drug, as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because the product is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their 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 Night Bullet without such an approved application violates these provisions of the FD&C Act.

Furthermore, Night Bullet is a "prescription drug" as defined at 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 other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, Night Bullet is not safe for use except under the supervision of a practitioner licensed by law to administer it. Night Bullet contains aminotadanafil, thiosildenafil and sulfohydroxyhomodildenafil, all PDE-5 inhibitors. 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 professional supervision of a practitioner licensed by law to administer such drugs.

According to section 502(f)(1) of the FD&C 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 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 Night Bullet fails to bear adequate directions for its intended use. Night Bullet 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 Night Bullet. For these reasons, Night Bullet is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].

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 of Night Bullet does not declare that it contains the PDE-5 inhibitors, aminotadanafil, thiosildenafil and sulfohydroxyhomodildenafil. The undeclared PDE-5 inhibitors in Night Bullet 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, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Further, consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or the potential drug interactions may seek products like Night Bullet because it is marketed as a dietary supplement. The failure to disclose the presence of aminotadanafil, thiosildenafil and sulfohydroxyhomodildenafil renders your product's labeling false and misleading. Night Bullet is, therefore, misbranded under Section 502(a) of the FD&C Act [21 U.S.C. § 352(a)].

The undeclared PDE-5 inhibitors contained in Night Bullet also causes it to be misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)], because the labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with the use of Night Bullet, particularly since someone who takes it would be unaware of the presence of the PDE-5 inhibitors, arninotadanafil, thiosildenafil and sulfohydroxyhomodildenafil. For example, patients who take nitrates and consume Night Bullet may be at risk of life-threatening hypotension.

The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

Street Drug Alternatives

In addition to "Night Bullet," your firm also markets "Hemp Garden Tea" as an alternative to an illicit street drug (street drug alternative). Labeling statements documenting the intended use of "Hemp Garden Tea" include, but are not limited to:


• "Chill your head with the good stuff!"
• The immediate container for the product "Hemp Garden Tea" includes marijuana leaves.


The claims above demonstrate that the product is to be used as a street drug alternative. Therefore, "Hemp Garden Tea" 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 an article (other than food) intended to affect the structure or any function of the body of man or other animals.2 Moreover, "Hemp Garden Tea" is a new drug, as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for its labeled use. 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 sale of "Hemp Garden Tea" without an approved application violates these provisions of the FD&C Act.

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 product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence as well as the occurrence of other violations. It is your responsibility to ensure that your firm, and any drug or dietary supplement product manufactured or distributed by you or your firm, comply with all requirements of federal law and FDA regulations.

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 as the FD&C Act authorizes under sections 302 and 304 of the FD&C Act [21 U.S.C. §§ 332 and 334]. In addition, there is criminal liability for all violations of the prohibited acts described in section 301 of the FD&C Act [21 U.S.C. §331]. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected.

Within fifteen 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. 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. You can find guidance and information for the regulated industry regarding regulations for drug products through links at FDA's website at http://www.fda.gov/oc/industry.

Your response should be sent to:


Blake Bevill, Director
Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612


If you have questions regarding any issues in this letter, please contact Dr. Raymond Brullo, Compliance Officer at 949-608-2918.


Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District



Cc: Marc C. Sanchez, Esq.
P.O. Box 8292
Atlanta, GA 31106


Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
Attn: FDA Correspondence

___________________________________________________

1 On March 11, 2013, your firm conducted a voluntary recall of lot B43N032 of "Night Bullet" after FDA found that the product contained undeclared phosphodiesterase type-5 (PDE-5) inhibitors.

2 While your firm represents "Hemp Garden Tea" as a conventional food within the meaning of section 201(f) of the FD&C Act [21 U.S.C. § 321(f)], the product does not fit within the "other than food" exception to the definition of"drug" in Section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)]. Street drug alternatives are intended to be used for recreational purposes to effect psychological states (e.g., to get high, to promote euphoria, or to induce hallucinations), and are not consumed primarily for taste, aroma, or nutritive value. See Nutrilab v. Schweiker, 713 F.2d 335 (7th Cir. 1983).

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm377975.htm