| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19900 MacArthur Blvd. Suite 300 Irvine, CA 92612-2445 Telephone: 949-798-7600 FAX: 949-798-7690 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL-
RETRUN RECEIPT REQUESTED
W/L 33-10
July 15, 2010
RT Naturals, LLC
101 Columbia
Suite 150
Aliso Viejo, CA 92656
Dear Mr. Walter:
Between December 17, 2009 and January 19, 2010, investigators from the Food and Drug Administration (FDA) inspected your firm and collected product samples and labeling. We have also reviewed your website, www.roaringtiger.com.
This letter concerns your firm’s marketing of the following products: “Roaring Tiger Male Performance Enhancer” patch, “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes,” “Roaring Tiger HD Black Label,” “Roaring Tiger Virility +,” and “Roaring Tiger Max.” These products are marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
Roaring Tiger Male Performance Enhancer Patch and Roaring Tiger Male Performance Enhancer Pre-Performance Wipes
Your firm’s website includes claims for your firm’s topical products, “Roaring Tiger Male Performance Enhancer” patch and “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes,” such as the following:
“Roaring Tiger Male Performance Enhancer” patch
- “Activates the CYP17 Enzyme Triggering Beneficial Hormone Cascade”
- “Boost Sex Drive and Libido”
- “Use of testosterone booster patch will restore your youthful sexual vigor, or give you a noticeable boost in libido.”
Roaring Tiger Male Performance Enhancer Pre-Performance Wipes
- “Unique New Formula with Yin Yang Huo (Horny Goat Weed/Epimedium), used in China for thousands of years as a male libido stimulator for harder, fuller erections.”
- “The absorption rate of the all-natural ingredients in the Roaring Tiger Pre-Performance Wipes is extremely rapid and will help you increase blood flow to the penis, resulting in a fuller easily sustainable erection.”
- “Unlike other erection formulas, Roaring Tiger Pre-Performance Wipes are applied directly to the shaft of the penis, bypassing digestive absorption problems as with doctor’s pills.”
The claims listed above make clear that the “Roaring Tiger Male Performance Enhancer” patch and “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes” are intended to affect the structure or any function of the body. Under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)) products (other than foods) that are intended to affect the structure or function of the body are defined as drugs. Your firm appears to market these products as dietary supplements because these products are listed as “Performance Supplements” on your website. However, the Act defines the term “dietary supplement” in 201(ff)(2)(A)(i) (21 U.S.C. § 321(ff)(2)(A)(i)), in part, as a product that is “intended for ingestion.” Because topical products, such as “Roaring Tiger Male Performance Enhancer” patch and “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes,” are intended to enter the body directly through the skin or mucosal tissues, they are not dietary supplements or foods. Therefore, “Roaring Tiger Male Performance Enhancer” patch and “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes” are drugs under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)).
In addition, your website states that “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes” contains aminophylline, the active pharmaceutical ingredient in an FDA-approved drug.
[1] Under section 201 (ff)(3)(B) of the Act, (21 U.S.C. §321(ff)(3)(B)), dietary supplements may not include articles approved as a new drug under section 505 of the Act, unless the article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Aminophyllin tablets as a new drug under section 505 of the Act on April 19, 1940. FDA is not aware of any aminophylline-containing products that were marketed as dietary supplements or as foods before this date. Therefore, regardless of its intended use as a topical product, the product “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes” is excluded from the definition of dietary supplement.
Both “Roaring Tiger Male Performance Enhancer” patch and “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes” are new drugs, as defined by section 201(p) of the Act (21 U.S.C. § 321(p)), because they are 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 Act (21 U.S.C. §§ 33l (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 these products without an approved application violates these provisions of the Act.
Moreover, “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes” 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 to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Indeed, all aminophylline products that have been approved for marketing by the 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 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. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 201.100(c)(2) and 201.115). Because there is no FDA-approved application for your firm's “Roaring Tiger Male Performance Enhancer Pre-Performance Wipes” product, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)). 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)).
Roaring Tiger Virility +
Your firm’s product, “Roaring Tiger Virility +,” is an unapproved and misbranded drug under the Act.
Your firm’s website includes claims for this product such as the following:
(Under ingredients tab)
- “L-arginine is also a key building block in repairing damaged tissue.”
- “Gotu Kola Powder . . . reduces pain and swelling; eliminates excess fluids; relieves congestion due to cold and upper respiratory infections.”
(Under Specialized Ingredients on the left side of your home page, further information is provided about L-Arginine Amino Acid and Horny Goat Weed (Epimedium), ingredients that your website states are in your Roaring Tiger Virility product)
For L-arginine:
- “For many people who do not maintain a healthy lifestyle or proper diet, a proper dietary supplement with L-arginine such as the one Roaring Tiger offers included with an assortment of other vitamins can reduce healing time of injuries, reduce the risk of heart disease . . . and prevent erectile dysfunction. L-arginine can be an effective natural alternative to Viagra.”
- “The difference between the two is that Viagra blocks an enzyme called PDE5 which breaks down nitric oxide and L-arginine is used to create nitric oxide….Additional benefits to increased Nitric Oxide
- Control infections
- Regulate blood pressure
- Prevents the formation of deadly blood clots
- Fights parasites and bacteria that invade the body”
For Horny Goat Weed (Epimedium):
- “For centuries [epimedium] has been used as a tonic for the reproductive system, boosting libido and treating impotence…”
- “Modern Day Benefits of Use
Horny Goat Weed . . .
- Anti-inflammatory and antibacterial
- It inhibits asthma caused by increased histamine
- Prevents and reverses bone loss”
The statements listed above make clear that “Roaring Tiger Virility +,” 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)).
Your firm markets this product as a dietary supplement. However, your website states that “Roaring Tiger Virility +” contains L-Dopa. L-Dopa is also known as levodopa, which is an active pharmaceutical ingredient in the FDA-approved drug Sinemet. Under section 201 (ff)(3)(B) of the Act, (21 U.S.C. §321(ff)(3)(B)), dietary supplements may not include articles approved as a new drug under section 505 of the Act, unless the article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Sinemet as a new drug under section 505 of the Act on May 2, 1975. FDA is not aware of any L-Dopa-containing products that were marketed as dietary supplements or as foods before this date. Therefore, regardless of its intended uses, “Roaring Tiger Virility +” is excluded from the definition of dietary supplement.
“Roaring Tiger Virility +” 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. §§ 33l (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 this product without an approved application violates these provisions of the Act.
Moreover, “Roaring Tiger Virility +” fails to bear adequate directions for use under section 502(f)(1) of the Act (21 U.S.C. §352(f)(1)). “Roaring Tiger Virility +” 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 to its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Indeed, all L-Dopa products which have been approved for marketing by the FDA are limited by an approved new drug application for use under the professional supervision of a practitioner licensed by law to administer such drugs. In addition, “Roaring Tiger Virility +” is offered for conditions, such as erectile dysfunction and heart disease, that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.
As explained above, 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” under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)) for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 201.100(c)(2) and 201.115). Because there is no FDA-approved application for “Roaring Tiger Virility +,” its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)). The introduction or delivery for introduction into interstate commerce of your misbranded product, “Roaring Tiger Virility +,” violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Roaring Tiger HD Black Label and Roaring Tiger Max
Unapproved and Misbranded Drugs
Your firm’s products, “Roaring Tiger HD Black Label,” and “Roaring Tiger Max” are unapproved and misbranded drugs under the Act.
Your firm’s website and product labels includes claims for these products such as the following:
Roaring Tiger HD Black Label
- (Product label) “HD Black Label delivers amazing appetite control and increased energy from the very first dose. A clinically tested and approved formula that was developed for years and used successfully in an actual obesity clinic.”
- “This product has been in obesity clinics for over 5 years and have (sic) helped patients lose THOUSANDS of pounds! In our obesity clinics, our product replaces gastric bypass and the O-band.”
- (Under ingredients tab) “Borage oil is used as an aid to weight loss. Obesity can sometimes be caused by inflammation in the body. Borage oil is used to reduce overall inflammation and therefore help weight loss.”
Roaring Tiger Max
(Under ingredients tab)
- “L-arginine . . . can help alleviate/reduce hypertension in some people.”
- “Ashwagandha powder . . . is excellent for . . . infertility, impotence, insomnia . . . rheumatism . . .. It is used externally for tumors, inflammation, arthritis, and a wide range of skin and infectious diseases, and internally as a pain killing tea.”
- “Panax Ginseng Ext. 25% . . . aids recovery from weakness after illness . . ..”
- “L-Tyrosine . . . used to treat depressions . . ..”
- “Yohimbe Bark . . .is mostly used to treat impotence for men and women.”
- “Macca Powder . . . has been credited with many healthful effects including…treating impotence . . . [r]educing chronic fatigue . . ..”
The statements listed above make clear that “Roaring Tiger HD Black Label” and “Roaring Tiger Max,” are each intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and to affect the structure or any function of the body. These claims cause your products to be drugs, as defined in section 201(g)(1) of the Act (21 U.S.C. § 321(g)(1)).
Moreover, “Roaring Tiger HD Black Label” and “Roaring Tiger Max,” are new drugs, as defined by section 201(p) of the Act (21 U.S.C. § 321(p)), because they are 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 Act (21 U.S.C. §§ 33l (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 these products without an approved application violates these provisions of the Act.
In addition, because “Roaring Tiger HD Black Label” and “Roaring Tiger Max,” are offered for conditions, such as infertility, depression, and impotence, that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use them safely for their intended uses. Thus, these products’ labeling fails 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)). “Roaring Tiger HD Black Label,” and “Roaring Tiger Max,” 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 your misbranded products, “Roaring Tiger HD Black Label” and “Roaring Tiger Max,” violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Misbranded Dietary Supplements
Even if “Roaring Tiger HD Black Label” and “Roaring Tiger Max” did not contain disease claims in their labeling that cause them to be drugs, they would still be misbranded as dietary supplements.
“Roaring Tiger HD Black Label” and “Roaring Tiger Max” are misbranded under section 403(q)(5)(F) of the Act (21 U.S.C. 343(q)(5)(F)) in that the presentation of nutrition information on their product labeling does not comply with 21 CFR 101.36. Examples of the deviations from the requirements of 21 CFR 101.36 include:
- Neither of the products’ labeling encloses the nutrition information in a box by using hairlines, as required by 21 CFR 101.36(e)(2).
- The labeling for “Roaring Tiger HD Black Label” does not separate each dietary ingredient listed from the dietary ingredient listed above and beneath it by a hairline rule centered between the lines of text, as required by 21 CFR 101.36(e)(5).
- Neither of the products’ labeling uses the heavy bar required by 21 CFR 101.36(e)(6).
- Neither of the products’ labeling uses a light bar between the headings “Amount Per Serving” and “% Daily Value,” as required by 21 CFR 101.36(e)(7).
- The labeling for “Roaring Tiger HD Black Label” lists both dietary ingredients with an established Reference Daily Intake (RDI) (e.g., Vitamin B-6) and dietary ingredients for which FDA has not set an RDI or Daily Reference Value (DRV). However, the labeling does not list the other ingredients under a heavy bar required to be placed beneath the last listed dietary ingredient with an established RDI or DRV, as required by 21 CFR 101.36(b)(3)(i).
In addition, your “Roaring Tiger Max” product is misbranded under section 403(a)(1) of the Act (21 U.S.C. § 343(a)(1)) in that its labeling lists Daily Values for substances for which no RDI or DRV has been established. Specifically, your “Roaring Tiger Max” labeling declares a % Daily Value for the ingredients ginger root extract, piper longum extract, and bioperine. FDA has not established an RDI or DRV for ginger root or bioperine. Therefore, these representations of Daily Values are false and misleading.
Further, your “Roaring Tiger HD Black Label” and “Roaring Tiger Max” products are misbranded under section 403(q)(1)(A) of the Act (21 U.S.C. 343(q)(1)(A)), because the product labeling fails to declare the correct serving size, as required by 21 CFR 101.36(b)(1).
Specifically, the serving size for dietary supplements must be determined in accordance with 21 CFR 101.9(b) and 21 CFR 101.12(b), Table 2. Under 21 CFR 101.9(b)(2), the serving size must be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion” (RACCs) that appear in 101.12(b). The RACC for dietary supplements is the maximum amount recommended, as appropriate, on the label for consumption per eating occasion. The labeling for “Roaring Tiger HD Black Label” recommends taking up to 2 capsules per eating occasion. Therefore, the serving size must be based on a RACC of 2 capsules. However, the labeling incorrectly declares the serving size as 1 capsule. Similarly, the “Roaring Tiger Max” labeling recommends taking up to 4 softgels per eating occasion and is therefore required to declare a serving size based on a RACC of 4 soft-gels. However, the labeling incorrectly declares the serving size as 1-2 soft-gels. .
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 all products marketed by your firm comply with the Act and its implementing 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 and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
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. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Please send your written response to:
Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612
If you have any questions regarding this letter, you may contact John J. Stamp at (949) 608-4464.
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
cc:Acting Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue – MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413
[1] Aminophylline, an approved prescription drug used in the treatment of asthma, contains ethylenediamine. FDA is concerned about the use of aminophylline in products marketed as dietary supplements in part because some individuals suffer from allergic reactions to ethylenediamine. See http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127641.htm.
-
No comments:
Post a Comment