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Wednesday, December 14, 2011

The Cake Box, Inc. 12/14/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700 

 

WARNING LETTER

VIA UPS


December 14, 2011


Carl M. Skropeta, President
The Cake Box, Inc.
3527 Wilkinson Lane
Lafayette, California 94549


Dear Mr. Skropeta:


 


The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 3527 Wilkinson Lane, Lafayette, California on September 20 28, 2011. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links in FDA's homepage at Your significant violations are as follows:


1. As required by 21 CFR 110.35(c), you must not allow pests in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators observed the following evidence of a lack of pest control:


• A dead rat was found located 3 feet from the storage of raw ingredients.


• Twenty five to thirty rodent pellets were found in the firm's storage room, 1 foot from the storage of raw ingredients.


• Five to 6 moths were seen in the production room. Four of the six were resting on a cotton cloth used to cover raw bread dough. One of the six moth was seen resting on the wooden table, in use to form bread dough.
 

• Rodent pellets were located in the storage room, as close as five feet from the storage of finished product cooling racks.


• Rodent nesting material located within the storage room.


2. As required by 21 CFR 110.80(b)(1), you must maintain all equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary. In addition, as required by 21 CFR 110.35(d), you must clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against the contamination of food. However, our investigators observed the following during the inspection:


• Roller racks used to transport raw bread dough and cooked/finished buns were covered with old product residue.


• Several baking pans were noted to have an accumulation of old product residue.


• Cotton cloths, used to cover raw bread dough, were covered with old product buildup.


• An employee was seen using a dough scraper to scrap the remnants of a dead moth off the table.


3. As required by 21 CFR 110.10(b)(3), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable organisms) in an adequate hand-washing facility at any time when the hands may have become soiled or contaminated.


However, our investigators observed the following during the inspection:


• Employees were observed starting work without washing their hands. These employees were seen handling the raw bread dough with their bare hands.


• An employee was seen smashing a moth on the production table with his bare hands, used the same hand to wipe it onto the floor, and immediately returned to forming bread dough without washing his hands.


4. As required by 21 CFR 110.10(a), any person who is shown to have, or appears to have an illness, open lesion, including boils, sores, or infected wound, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food packaging materials becoming contaminated, shall be excluded from any operation which may be expected to result in such contamination until the condition is corrected. However, our investigators observed an employee with an open lesion on the hand handling raw dough product without the use of hand coverings.


5. As required by 21 CFR 110.10(b), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. However, our investigators observed an employee was not wearing hair covering in the processing of finished, ready to eat muffins. Effective hair restraints such as hair nets or headbands must be worn where appropriate and in an effective manner (21 CFR 110.10(b)(6)).


Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.


Your written response should be directed to:


Darlene B. Almogela
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052


Refer to the Unique Identification Number (CMS case 238496) when replying.


If you have any questions about the content of this letter please contact Mr. Lawton W. Lum, Compliance Officer at (510) 337-6792.


This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.


Sincerely,
/S/

Barbara J. Cassens
District Director

Nenningers Naturals, LLC 12/14/11

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

New York District
158-15 Liberty Avenue
Jamaica, NY 11433
 

December 14, 2011

WARNING LETTER NYK-2012-07

VIA UNITED PARCEL SERVICE

Nenningers Naturals, LLC
Attn: Dr. Steve Nenninger, Website Owner
17 Youngs Lane
East Setauket, NY 11733

Dear Dr. Nenninger:

The Food and Drug Administration (FDA) has reviewed your website at Internet address www.triplefludefense.com and has determined that “Triple Flu Defense” is being promoted for conditions that cause the product to be a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 USC 321(g)] and a biologic, as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 USC 262]. Triple Flu Defense is considered to be a drug because the therapeutic claims as shown on your website establish the product's intended use as a drug. We note that at least one component of the product is recognized in the Homeopathic Pharmacopeia of the United States (HPUS). Please be aware that a product's compliance with requirements of the HPUS does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.

Background

Triple Flu Defense is a drug under section 201(g) of the FD&C Act. According to your website, the product contains Influenzinum 30C. This component is listed in the HPUS.

Your website provides a mechanism for purchasing the product through the site. Specifically, the website ordering page offers shipping to addresses within the United States.

False or Misleading Information

The information on your website is false or misleading. For example, your website makes effectiveness claims, but it lacks adequate descriptions of the risks, warnings, and contraindications of your product. Consequently, your product is misbranded under sections 502(a), 502(f)(1), and 201(n) of the FD&C Act, and is marketed in violation of sections 301(a) and 301(b) of such Act.

Examples of some of the claims observed on your website include:

On the homepage:

â–“Seasonal Defense”
â–“Relieves Flu Symptoms”
â–“Eases Flu Vaccine Side Effects”
â–“…[T]his product is of inestimable value in the prevention and mitigation of influenza.”

On the webpage titled, “Product Info”:

â–“Unique Homeopathic Formula Adjusted Each Year to Combat Current Season’s Flu Viruses”

On the webpage titled, “Frequently Asked Questions”:

â–“How does Triple Flu Defense work?”

“Triple Flu Defense is taken once per week for optimum defense throughout the flu season – October to May – and can be started at any time. If you are experiencing flu symptoms, it is taken 3 times per day until symptoms subside.”

â–“Can I take Triple Flu Defense with the flu vaccine?”

“Triple Flu Defense can also be used to alleviate side effects from the flu vaccine.”

In addition, your website includes claims in the form of testimonials that establish the intended use of your product as a drug. Examples of these testimonials include the following:

On the webpage titled, “Our Customers”:

â–“Triple Flu Defense is a much needed solution for patients who have reacted to the flu vaccine or the flu. One of my patients had Guillain-Barre syndrome after the flu last year. He endured a long and difficult recovery. This year he is taking Triple Flu Defense with the confidence that homeopathic remedies are the best guard against viral flu infections.”

â–“It really works. My husband didn’t take the formula and got sick and I didn’t. It has no side effects.”

â–“I have been around people with the flu and haven’t gotten sick since taking Triple Flu Defense.”

â–“…[Y]our Triple Flu Defense works great. My son had no reactions and did not catch the flu this year.”

â–“I swear by Dr. Nenninger’s Triple Flu Defense formula. It got me well, it got me better.”

â–“I had been sick for a week with the flu and thought I was never going to feel better. I took two doses of Triple Flu Defense and felt a lot better. It works great.”

â–“I'm one of the few people I know who didn't get the flu this past year because of Triple Flu Defense!”

â–“I took Triple Flu Defense during the season. I didn’t get sick all winter.”

We also note that FDA picked up promotional material titled, “A New Approach to the Flu” at the 2011 Natural Products Expo East trade show that was held on September 22-24, 2011 at the Baltimore Convention Center. Claims included in the promotional literature include the following:

In a text box featuring a testimonial which is also on the homepage of your website:

â–“…[T]his product is of inestimable value in the prevention and mitigation of influenza.”

Under the heading, “Reformulated Each Year”:

â–“…[W]e take the extra time and expense to reformulate each year for maximum effectiveness in fighting the current influenza viruses.”

Under the heading, “Unique Homeopathic Formula”:

â–“To relieve flu symptoms, it is taken 3 times per day.”

Claims on your website and product labeling that promote your product for use in the cure, mitigation, treatment, or prevention of disease may establish that your product is a drug. Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].

Moreover, we also note claims made on your Facebook account accessible at: https://www.facebook.com/#!/pages/Triple-Flu-Defense/144882121178

In a post on September 9, 2011:

â–“School has started! Now is the time to think about flu prevention. The new formula is out on the shelves at your local stores and practitioners offices. Start your weekly prevention dose now.”

This claim is also found on your Twitter account (@TripleFluDefens) accessible at: http://twitter.com/#!/triplefludefens

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Furthermore, your product is offered for conditions 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 this drug safely for its intended purpose. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

This letter is not intended to be an all-inclusive review of your websites and products your firm may be marketing. It is your responsibility to ensure that all products marketed by your firm are in compliance with the FD&C and PHS Acts and their implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action such as seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or E-mail at dean.rugnetta@fda.hhs.gov

Sincerely,

/s/

Ronald M. Pace
District Director
New York District

Monday, December 12, 2011

1 800 Get Thin LLC 12/12/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993 

WARNING LETTER

December 12, 2011

VIA UNITED PARCEL SERVICE


Robert Silverman, Esquire
1-800-GET-THIN, LLC
25 S. Oak Knoll Ave.
Ste 504
Pasadena, CA 91101
 


Refer to GEN1001514 when replying to this letter.


Dear Mr. Silverman:

 

We are reissuing this letter because we sent a letter, dated December 9, 2011, to your prior street address.


The Food and Drug Administration (FDA) has learned that, through means including the entity 1-800-GET-THIN, the San Diego Ambulatory Surgery Center, LLC, is marketing the LapBand gastric banding system (LapBand) in the United States (U.S.) in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The LapBand is a device within the meaning of Section 201 (h) of the Act, 21 U.S.C. § 321 (h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body. Your promotion of the LapBand misbrands the device under sections 502(q), 502(r), and 201 (n) of the Act, 21 U.S.C. §§ 352(q), 352(r), and 321 (n).


Under section 515(d)(1)(B)(ii) of the Act, 21 U.S.C. § 360e(d)(1)(B)(ii), FDA may require as a condition of approval of a device that the sale and distribution of the device be restricted to the extent permitted under section 520(e) of the Act, 21 U.S.C. § 360j(e). FDA's approval of the LapBand restricted this device by requiring that it only be sold and distributed upon authorization by a licensed practitioner (i.e., under prescription). Section 502(q) of the Act provides that a restricted device is misbranded if its advertising is false or misleading in any particular. According to section 201 (n) of the Act, in determining whether a device's labeling or advertising is misleading, the extent to which the labeling or advertising fails to reveal material facts must be taken into account. In addition, a restricted device is misbranded under section 502(r) of the Act if the device's distributor does not include in all advertisements and other descriptive printed material a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications.


Examples of the advertising pieces we reviewed that misbrand the LapBand follow:


1. We reviewed two photos of billboards. The billboards read:


"LOSE WEIGHT WITH THE LAP-BAND! SAFE 1 HOUR, FDA APPROVED 1-800-GET-THIN; 1-800-953-5000; PPO INSURANCE; FREE INSURANCE VERIFICATION" "MARCIANO LOST 125 POUNDS; LAP-BAND WEIGHT LOSS REVOLUTION! CALL 1-800-GET-THIN; 1-800-953-5000; PPO INSURANCE; FREE INSURANCE VERIFICATION"


2. We also reviewed several advertising inserts. One insert reads, "Celebrate Black History Month! Let Your New Life Begin! 1-800-GET-THIN." The other insert reads, "Significantly Overweight? CALL: 1-800-GET-THIN." The text and photograph on the back of both inserts are the same. In large text is the statement, "LET YOUR NEW LIFE BEGIN!" Below the text is a photograph of a woman with a caption that reads, "I LOST 130 POUNDS." In very small print below the woman's photograph is the following text:


"You may be a candidate for the LAP-BAND® if your BMI is over 40 or between 35 and 40 with other specific medical conditions. The LAP-BAND® procedure has certain risks, side effects and contraindications. Consult your physician before deciding if the LAP-BAND® is right for you. For more information visit, www.1800getthin.com/safety. Typically with the LAP-BAND®, 1-2 pounds of weight loss per week and 50-70% of excess weight lost and maintained at 5 years can be expected."


Below this language is the final caption, printed in very large font: "GET THE LAP-BAND! CALL NOW! 1-800-GET-THIN HOURS: 6:30AM- 10PM • (1-800-540-8000) BEVERLY HILLS|WEST HILLS|VALENCIA|PALMDALE|APPLE VALLEY|BAKERSFIELD|COVINA|SANTA ANA|LONG BEACH|SAN BERNARDINO| SAN DIEGO"


Another insert features a woman named Christine. Above her photo, in very large print, is the caption, "I LOST 90 POUNDS WITH THE LAP-BAND!" Next to her photograph, the following testimonial is printed:


"I'm Christine. I have lost 90 pounds with the Lap-Band! I struggled forever to lose weight. I tried everything! Crazy diets, workout videos, personal trainers. I always ended up back at the same weight. The Lap-Band has helped thousands of happy people safely and effectively lose weight and keep it off! .. .The Lap-Band is changing lives one pound at a time. If you are ready to lose weight, pick up the phone and call 1·800-GET THIN. You can lose the weight with the Lap-Band just like I did."


Following the testimonial the caption reads, "Free Seminar at a Location Near You! Covered by PPO Insurance. LOSE WEIGHT NOW! Call Now For Your FREE Lap-Band Guide." Below this statement is cautionary information in small font, which provides, "Consult your physician to discuss risks and other options. See 1800GETTHIN.com/safety. Studies show about a 50%- 60% excess weight loss at 3 years." The final text located on the bottom of the insert in very large print is "1-800-GET-THIN Hours 7am-10pm 1-800-953-5000."


These advertisements fail to reveal material facts, including relevant risk information regarding the use of the LapBand, age and other qualifying requirements for the LapBand procedure, and the need for ongoing modification of eating habits, as provided in the approved LapBand labeling. Therefore, the advertisements are misleading within the meaning of section 201 (n) of the Act and misbrand the LapBand under section 502(q) of the Act. In addition, while some of your advertisements make mention of risks and suggest a physician consultation, these advertisements do not adequately state the LapBand's relevant warnings, precautions, side effects, and contraindications. Therefore, the advertisements also misbrand the LapBand under section 502(r) of the Act.


Note also that we are concerned that the information your firm does provide related to risks is in font that may be so small as to render the information illegible.

FDA requests that 1-800-GET-THIN immediately cease marketing the LapBand using advertising that violates the Act. The firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. Such action could include seizure, injunction, and civil money penalties.

1-800-GET-THIN must notify this office in writing within fifteen working days from the date you receive this letter of the specific steps it has taken to correct the noted violations, including an explanation of how the firm plans to prevent these violations, or similar violations, from occurring again, and including documentations of the corrective actions taken. If corrective action cannot be completed within fifteen working days, 1-800-GET-THIN’s response should state the reason for the delay and the time within which the corrections will be completed. The response should provide a translation of documentation not in English to facilitate our review, and it should be sent to:
 

Terri T. Garvin
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3521
Silver Spring, MD 20993

Finally, 1-800-GET-THIN should know that this letter is not intended to be an all-inclusive list of the firm’s violations of the Act. It is the firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.

Sincerely yours,

/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health