Intelli Health Products, LLC 4/27/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751 Telephone: 407-475-4700 FAX: 407-475-4770

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-11-25

April 27, 2011

Mrs. Stacy N. Sujanani, President
Mr. Sanjay Sujanani, Manager
Intelli Health Products, LLC
12809 Killarney Court
Odessa, FL  33556-5420

Dear Mr. and Mrs. Sujanani:

This letter concerns your firm’s marketing and distribution of the product “Duro Extend.” “Duro Extend” is labeled as a dietary supplement.  As described below, “Duro Extend” is an unapproved new drug in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a) and 331(d)] and is misbranded in violation of sections 502(f) and 502(a) [21 U.S.C. §§ 352(f) and 352(a)] of the Act. 

Laboratory analyses conducted by the U.S. Food and Drug Administration (FDA) concluded that multiple lots of “Duro Extend” contain sulfoaildenafil and/or aildenafil, both of which are phosphodiesterase type-5 (PDE-5) inhibitors and analogues of sildenafil.¹ Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved drug for the treatment of erectile dysfunction (ED). According to statements on the label of “Duro Extend,” it is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body.  These statements include, but are not limited to, the following:

• “Male Enhancer.”
• “Herbal dietary supplement for men, Duro™ may help increase pleasure and performance.”

These statements make clear that “Duro Extend” is a drug under section 201(g)(1) of the Act [21 U.S.C. §§ 321(g)(1)] because it is intended to affect the structure or function of the body. Under section 201(g)(1) of the Act (last sentence), the structure/functions claims made for dietary supplements must be made in accordance with section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)], and if such claims do not conform to section 403(r)(6), 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. However, the male enhancement structure/function claim made for “Duro Extend” does not describe the effects of nutrients or dietary ingredients in the product.  Rather, the structure/function claim is clearly made for the product as it relates to its sulfoaildenafil and/or aildenafil content. Since sulfoaildenafil and aildenafil are not nutrients or dietary ingredients, as defined in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)], but synthetic active pharmaceutical ingredients, claims about improvement of sexual function do not conform to section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)]. Accordingly, “Duro Extend” is a drug within the meaning of section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)].

Moreover, “Duro Extend” 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 their 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 marketing and distribution of “Duro Extend” without such an approved application violates these provisions of the Act.

Furthermore, “Duro Extend” is a “prescription drug” as defined at section 503(b)(1)(A) of the Act [21 U.S.C. § 503(b)(1)(A)], in that their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. 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 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. As such, the labeling of “Duro Extend” fails to bear adequate directions for its intended use. “Duro Extend” is not exempt from the requirement that its labeling bear adequate directions for use under 21 CFR §§ 201.100(c)(2) and 201.115 because no FDA-approved application is in effect for “Duro Extend.”  For these reasons, “Duro Extend” is 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 “Duro Extend” does not declare that it contains the PDE-5 inhibitors, sulfoaildenafil and/or aildenafil.  The undeclared PDE-5 inhibitors in “Duro Extend” 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. Further, consumers who have been advised against taking PDE-5 inhibitors because of comorbidities or potential drug interactions may seek products like “Duro Extend” because they are marketed as not containing the active ingredients in approved ED drugs. The failure to disclose the presence of sulfoaildenafil and/or aildenafil renders your product’s labeling false and misleading. “Duro Extend” is therefore misbranded under Section 502(a) of the Act [21 U.S.C. § 352(a)]. 

The undeclared PDE-5 inhibitors contained in “Duro Extend” also cause it to be misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)], because the labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of “Duro Extend,” particularly since someone who takes it would be unaware of the presence of sulfoaildenafil and/or aildenafil. For example, because sulfoaildenafil and aildenafil are analogues of sildenafil and are PDE-5 inhibitors, patients who take nitrates and consume “Duro Extend” may be at risk of life-threatening hypotension. Consequently, your product, “Duro Extend,” is misbranded under sections 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)].

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. It is your responsibility to ensure that any drug or dietary supplement products manufactured or distributed by you meet all of the 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. Other federal agencies may take this Warning Letter into account when considering the award of contracts. 

Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.

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 reply should be sent to the Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751, to the attention of Salvatore N. Randazzo, Compliance Officer. If you have any questions regarding the content of this letter, please contact Mr. Randazzo at (407) 475-4712.

Sincerely,

/s/

 

Emma R. Singleton
Director, Florida District

C: (b)(4)

¹ In October 27, 2010, your firm conducted a voluntary recall of specific lots of "Duro Extend" after FDA found that the product contained sulfoaildenafil. In December 2, 2010, your firm expanded your voluntary recall to include all lots of"Duro Extend.

 

 

 

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La Placita Botanas Mexicanus, Inc. 4/26/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

W/L 36-11

Date: April 26, 2011

Mr. Gabriel Sanchez, President/Owner
La Placita Botanas Mexicanus, Inc.
10846 Central Avenue
South El Monte, CA 91733-3310

Dear Mr. Sanchez:

On October 18-26, 2010, and again on December 26, 2010 - January 3, 2011, the Food and Drug Administration (FDA) conducted two inspections of your snack food manufacturing facility located at 10846 Central Avenue, South El Monte, California. During these inspections our investigators collected samples of your product labeling. Our review of your product labels found that your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) products are misbranded within the meaning of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §343] and Title 21, Code of Federal Regulations (CFR) Part 101. Specifically,

1. The labels for your various snack food products are misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition information on their labels does not comply with the format and content requirements in FDA's regulations. Specifically, your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) product labels fail to provide nutrition information in accordance with 21 CFR 101.9. The label stock for these products that was in use at the time of the inspections states "FOR NUTRITION INF. CALL ... " and does not provide any further nutritional information. Under 21 CFR 101.9(j)(13)(i)(A), there is an exemption to the nutrition labeling requirements for foods in small packages that have a total surface area available to bear labeling of less than 12 square inches, provided that the labels for these foods bear no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) packages measure 16.75 in. x 9 in., 10 in. x 8 in., and 6 in. x 9 in. respectively per side. These packages bear more than 12 square inches of total surface area available to bear labeling; therefore, your products do not qualify for the nutrition labeling exemption under 21 CFR 101.9(j)(13)(i)(A).

2. Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) products are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because these foods are fabricated from two or more ingredients, but the labels do not list all ingredients found in the foods. For example:

• Your products that are labeled "con chile" contain a chili powder blend; however, the label for your Anillos Michoacanos Con Chile (2.5 oz.) product does not declare chili powder or spice in the ingredients statement in accordance with 21 CFR 101.4.

• Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) product labels fail to declare the sub-ingredients of the multi-ingredient food, baking powder. According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

This letter may not list all the label violations at your facility. You are responsible for ensuring that your products are properly labeled, and that your processing plant operates in compliance with the Act, the Food Labeling regulation (21 CFR 101) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from further violating the Act.

We also have the following comments about your product labels:

• Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) product labels include the ingredient "Cotton Salad Oil." We question whether this ingredient is declared by an appropriate common or usual name under 21 CFR 101.4.

• Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) product labels improperly declare the ingredients "Yellow 5 and 6 Certificate." According to 21 CFR 101.22(k), a color additive subject to certification under 721 (c) of the act shall be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter, except that it is not necessary to include the "FD&C" prefix of the term "No." in the declaration. The applicable regulations, 21 CFR 74.705 and 706, do not allow for these colors to be listed collectively and do not include "certificate" in the name of these colors.

• Your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) product labels fails to declare oil ingredients in accordance with 21 CFR 101.4(b)(14). Your labels declare "Contains One or More Vegetable Oil, Corn Oil, Soybean Salad Oil, Cotton Salad Oil" and "Vegetable Oil (Contains One or More)(Corn, Soybean Salad Oil, Cotton)." According to 21 CFR 101.4(b)(14), oil ingredients not present in the product may be listed if they may sometimes be used in the product and shall be identified by words indicating that they may not be present, such as "or", "and/or", "contains one or more of the following:" e.g., "vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)".

We also acknowledge that during the December 26, 2010 - January 3, 2011 inspection, your firm provided our investigators with two proposed new and revised labels for your (b)(4) products. A review of these labels also finds these products to be labeled incorrectly. We offer the following comments:

 

• Your (b)(4) label is a single-serving container; however it does not express the serving size in terms of a description of the individual container or package (e.g., can, box, package) in accordance with 21 CFR 101.9(b)(5)(iv).

• The number of servings per container in the Nutrition Facts panel of your (b)(4) product is incorrect. In accordance with 21 CFR 101.9(b)(8)(i), the number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term about (e.g., about 2 servings, about 3.5 servings). Your serving size is listed as 1 oz (28g); however, the servings per container is listed as 1. Since your package contains 71 g (b)(4) and each serving is 28 g, your servings per container should be about 2.5 (71g/21g~2.5).

• We note that your (b)(4) and (b)(4) product labels include nutrition information in a tabular format. A firm may use a tabular or linear nutrition facts format if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape of size cannot accommodate a standard vertical column or tabular display on any label panel [21 CFR 101.9(j)(13)(i)(B)]. In addition, the tabular display format may be used if there is not sufficient continuous vertical space (i.e. approximately 3 in.) to accommodate the required components of the nutrition label up to and including the mandatory declaration of iron [21 CFR 101.9(d)(11)(iii)]. If your packaging fails to meet one of these conditions, you are not eligible to use the tabular display for nutrition information.

• Your (b)(4) and (b)(4) continue to bear ingredients that are improperly declared. As discussed previously in this letter:

o Baking powder is a multi-ingredient food for which sub-ingredients must be declared in accordance with 21 CFR 101.4(b)(2).

o The color additives "Yellow 5 and 6 Certificate" are not declared in accordance with 21 CFR 101.22(k).
 

o Vegetable oils are not declared in accordance with 21 CFR 101.4(b)(14).

We recommend that you revise these proposed labels based on the above comments and begin immediate use of the corrected product labels.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as revised or proposed labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 608-4409. Your written reply should be addressed to:

Blake Bevill, Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612

Sincerely,
/S/

Alonza E. Cruse, Director
Los Angeles District
 

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Guangxi Jisheng Foods Inc 4/26/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD

WARNING LETTER

 

 

VIA OVERNIGHT MAIL

 

Mr. Zhang Longfu, President

Guangxi Jisheng Foods Inc.

5 Latitude Four Road

Liujing Industrial Park, Liujing

Hengxian County

China

 

Reference No.: 167295

 

Dear Mr. Longfu:

 

The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food facility located at 5 Latitude Four Road, Liujing Industrial Park, Liujing, Hengxian County, China on January 17-21, 2011.  During that inspection, we found that your firm had serious deviations from the low-acid canned food regulations (21 CFR Parts 108 and 113).  Failure to comply with all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a basis for the immediate application of the emergency permit control provisions of Section 404 of the Act and particularly implementation of 21 CFR 108.35(k) for products offered for entry into the United States.  In addition, such failure renders your low-acid canned food products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). Accordingly your canned food products are adulterated in that they have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the acidified food regulations through links in FDA’s home page at http://www.fda.gov.

 

This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. We have the following concerns with regard to your low-acid canned food products:

• Your firm failed to have heat distribution data on file which demonstrates that adequate venting of air is accomplished, as required by 21 CFR 113.40(a)(12)(iii). Specifically, according to your processing records for canned mushrooms, your firm frequently vents three retorts at the same time. However, the heat distribution data on file at your facility indicates that you should avoid venting more than (b)(4) at the same time due to the size of your main steam line. On at least three occasions your venting records indicate that you vented (b)(4) at the same time, contrary to the recommendation of your process authority.   Although you spoke with your process authority regarding the three simultaneous venting instances discovered during our inspection and indicated that the products were considered safe, we continue to have concerns regarding your practice of venting more than (b)(4).
• Your firm failed to record required information on designated forms at the time the observation was made by the retort or processing operator or designated person, as required by 21 CFR 113.100(a). Specifically, your firm indicated that not all data is entered on records at the time the observation or test results are known. Of particular concern, our investigators discovered multiple records entitled “Production Workshop Clock Calibration Record” dated October 26, 2008 with different results for clock calibration. In addition, our investigators also observed instances where blank QC records contained the signature of a supervisor signifying the records had been reviewed for completeness and accuracy.
• Your firm failed to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye, as required by 21 CFR 113.60(c). Specifically, (b)(4) of canned pieces and stems mushrooms (215x400 size cans) processed on January 9, 2011, were being stored in your warehouse unlabeled and uncoded. In addition, (b)(4) of canned whole button mushrooms (211x211 size cans) were also being stored in your warehouse, some of which were unlabeled and uncoded.

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.

 

If you do not respond or if we find your response inadequate, we may take further action.  For instance, we may take further action to refuse admission of your imported low-acid canned food products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the canned food regulations (21 CFR Part 108 and 113) is Import Alert #99-04. This alert can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.

 

This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the low-acid canned food regulations (21 CFR Part 108 and 113), and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

 

Please send your reply to the U. S. Food and Drug Administration, Attention:  Brandon Bridgman, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Mr. Bridgman at (301) 436-2073 or via email at Brandon.Bridgman@fda.hhs.gov.

 

Sincerely,

/S/

William A. Correll

Acting Director

Office of Compliance

Center for Food Safety

   and Applied Nutrition

                                                                                   

 

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Close Out Letter

• Guangxi Jisheng Foods Inc- Close Out Letter 6/30/11

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