A & H Farms 13-Sep-05

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Atlanta District Office 60 8th Street, N.E. Atlanta, GA 30304

September 13, 2005

VIA FEDERAL EXPRESS

WARNING LETTER
(05-ATL-23)

John Anthony, Owner
A & H Farms
1570 East Cherokee Street
Blacksburg, SC 29702

Dear Mr. Anthony.

A tissue residue report received by the U.S. Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a cow that originated from your livestock operation. Subsequently, an investigation of your livestock operation by a Food and Drug Administration investigator on August 4, 2005, confirmed that a dairy cow purchased and sold on or about May 5, 2005, for slaughter for human food to [redacted] in [redacted] was adulterated within the meaning of Section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act).

The United States Department of Agriculture (USDA)Food Safety and Inspection Service (FSIS) analysis of tissue collected from that animal (Case No.8-0221-05) disclosed the presence of illegal levels of the drug dihydrostreptomycin in the kidney tissue. The kidney tissue was found to contain 4.19 parts per million (ppm) of dihydrostreptomycin. A tolerance of 2.0 ppm has been established for residues of dihydrostreptomycin in the edible tissues of cattle. The tolerances for dihydrostreptomycin are listed in Title 21, Code of Federal Regulations. Section 555.200 (21 CFR 555.200).

In addition, USDA/FSIS has reported the finding of illegal residues in another cow sold by you and offered for slaughter for human food. You offered for sale for slaughter a beef cow to [redacted] in [redacted] on or about February 9, 2005. USDA/FSIS analysis of tissue collected from that animal (Sample number 415922) disclosed the presence of illegal levels of the drug penicillin in the liver and kidney tissues. The liver tissue was found to contain .09 ppm of penicillin and the kidney was found to contain .78 ppm of penicillin. A tolerance of .05 ppm has been established for residue of penicillin in the edible tissues of cattle. The tolerances for penicillin are listed in 21 CFR 556.510. Copies of the referenced 21 CFR regulations are enclosed.

Our investigation found that you routinely fail to inquire about the medication status of the animals that you or your associates purchase and subsequently deliver for slaughter for human consumption. You make no effort to determine if these animals have been medicated and require withholding from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. You maintain no records sufficient to determine the source of the animals you purchase. In fact, you and your associates routinely remove animal identification tags after purchase so as to make any efforts to trace back the source of the animal extremely difficult, if not impossible.

You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animal. As such, you, share the responsibility for violating the Act. To avoid future illegal residue violations you should take precautions such as:

1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;

2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and

3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not bb offered for human food, and it should be clearly identified and sold as a medicated animal.

You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

You should notify this office in writing within fifteen (15) working days of the steps you have take to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your reply should be directed to the attention of Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.

Sincerely,

/S/

Mary H. Woleske, Director
Atlanta District

 

-

A Perfect Food Company, LLC 25-Aug-05

Department of Health and Human Services	Public Health Service Food and Drug Administration
	555 Winderley Place, Suite 200 Maitland, Florida 32751

 

WARNING LETTER

FLA-05-47

August 25, 2005

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Ms. Karen Pignato, President

A Perfect Food Company, L.LC.

6920 SW 56th Court

Davie, FL 33314

REGISTERED MAIL

RETURN RECEIPT REQUESTED

Michael Patriquen, Founder

Med Marijuana Inc.

Suite 100-178

1600 Bedford Highway

Bedford, Nova Scotia

B4A 1 E8

Canada

Dear Sir/Madam:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.med-marijuanausa.com and has determined that the product Med-Marijuana™Cannabis Sativa is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)]. The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.

Examples of some claims observed on your web site include:

• "Cannabis Sativa . . . A Natural Health Choice! Rheumatoid arthritis, Fibromyalgia, Diabetes, MS . . . . Cannabis Sativa-the Marijuana plant-has been used by many suffering from those conditions, for all of that time."
• "Positive effects of low-THC Cannabis oil on Rheumatoid Arthritis"
• "Cancer Tumor shrinking abilities of non-psychoactive Cannabis."
• "Acting as a blood thinner, Cannabis Sativa has been reported to prevent the formation of blood clots which can [sic] heart attacks. Anyone with a family history of heart disease or is suffering from heart disease itself should be using this product daily to immediately assist their cardiovascular health which will help avoid a future cardiac event."
• "Acting as a vasodilator, Cannabis Sativa has been reported to open the veins of the body which helps prevent stroke while at the same time reduces blood pressure."
• "Diabetics taking our product tell us that they have tapered completely off Insulin, have normal sugar levels . . . ."
• "Clients using Cannabis Sativa in relation to their MS, Fibromyalgia and other painful auto-immune disorder symptoms have reported a major decrease or total elimination of their pain levels after continuing with the product for 30 to 90 days."

Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is also a "new drug" under section 201(p) of the Act; [21 U.S.C. 321(p)]. New drugs 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. Your Med-Marijuana™ is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].

This letter is not an all-inclusive review of your website and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S.C. 332 and 334]. You should take prompt action to correct the violations identified in this letter and any other violations of the Act. Failure to do so may result in enforcement action without further notice.

Furthermore, this letter does not address whether the importation of your product into the United States, or the distribution of the product within the United States, is permissible under the Controlled Substances Act (21 USC 801 et seq.) and the Controlled Substances Import and Export Act (21 USC 951 et seq.), which are administered by the Drug Enforcement Administration.

Please advise this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be addressed to Shari H. Shambaugh, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751.

Sincerely,

/S/

Emma R. Singleton

Director, Florida District

 

-

Company Response Letter 4/26/10

• A Perfect Food Company, LLC Response Letter

-

-

A&A Services 06-Apr-05

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Francisco District 1431 Harbor Bay Parkway Alameda. CA 94502-7070 Telephone : 510-337-6700

 

 

VIA FEDERAL EXPRESS

Our Reference: 3004508183

April 6, 2005

Priscilla D. Shaw
Owner
A&A Services
92-353 Laaloa St.
Kapolei, HI 96707

WARNING LETTER

Dear Ms. Shaw:

On January 10 and 11, 2005, we inspected your animal feed distribution operation located at 92-353 Laaloa St., Kapolei, HI 96707, and found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000)-Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).

Products that contain or may contain protein derived from mammalian tissues and that are intended for use in animal feed (prohibited material) must be labeled with the cautionary statement, "Do not feed to cattle or other ruminants" [21 C.F.R. 589.2000(d)(1) and (cx1)(i)]. Our inspection found that you are not labeling the products you are distributing to swine farms, which contain food waste from restaurants and hospital cafeterias, with this caution statement. As a result, these products are misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(a)(1)).

Our inspection also found that you use the same containers to hold both prohibited materials [redacted] waste to be used for feed for non-ruminants and non-prohibited materials [redacted] waste to be used for feed for ruminants). However, you failed to provide written procedures specifying clean-out procedures or other measures to avoid cross-contamination of the feed products to be used for ruminants [21 C.F.R. 589.2000(e)(1)(iv)]. You also failed to make copies of distribution records available for FDA inspection and copying (21 C.F.R. 589.2000(c)(1)(ii)].

At the conclusion of the inspection, these and other observations were listed on Form FDA 483, Inspectional Observations, which was issued to and discussed with you at the close of the inspection . A copy of this form is enclosed for your ready reference.

The above is not meant to be an a11-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all of your products are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur: Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

You should notify this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective actions cannot be completed in fifteen (15) days, state the mason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Your reply should be directed to Paul A. Peterson, Compliance Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, you may contact Mr. Peterson at (510) 337-6856.

Sincerely,

/S/

Barbara J. Cas
District Director
San Francisco District

-

AA Dairy 30-Mar-05

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158-15 Liberty Avenue Jamaica, NY 11433

 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

March 30, 2005

File No: NYK 2005-08

Aaron L. Aman, Partner
AA Dairy
56 Footes Crossing Rd.
Candor, NY 13743-1426

Dear Mr. Aman:

On December 8 and 15, 2004, U.S. Food and Drug Administration investigators conducted an inspection at your farm located in Candor, New York. This inspection confirmed that you offered three animals for sale for food that were adulterated within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4)of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U .S.C. Sections 342(a)(2)(C)(ii) and 342(a)(4)]. The inspection also revealed that you caused medicated feeds to be adulterated within the meaning of Section 501(a)(6 of the Act) [21 U.S.C. Section 351(a)(6)J.

On or about October 18, 2004, you offered for sale a calf identified with sale tag [redacted] slaughter as human food. The calf was sold to and slaughtered at [redacted] USDA analysis of tissue samples collected from that animal identifed the presence of 4.69 ppm neomycin in kidney tissue.

On or about March 29, 2004, you offered for sale a calf identified with backtag [redacted] for slaughter as human food. The calf was sold to and slaughtered at [redacted] USDA analysis of tissue samples collected from that animal identified the presence of 5.05, ppm neomycin in kidney tissue.

On or about March 29, 2004, you offered for sale a calf identified with backtag [redacted] for slaughter as human food. The calf was sold to and slaughtered at [redacted] USDA analysis of tissue samples collected from that animal identified the presence of 2.13 ppm neomycin in kidney tissue.

There is no established tolerance for neomycin in calves (Title 21 Code of Federal Regulations,Section 556.430). The presence of this drug at the level reported in these animals causes the food to be adulterated.

Our investigation also found that you hold animals on your farm under conditions that are so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records for bull calves fed medicated milk replacer, lack a system for assuring that the milk replacer is used in a manner not contrary to label instructions, and lack a system for assuring the medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drug residues from edible tissues. Foods from animals held under such conditions are adulterated under Section 402(a)(4) of the Act [21 U.S.C. Section 342(a)(4)].

You adulterated the medicated feed [redacted] Calf Milk Replacer, which contains neomycin, when you used it in calves to be processed for veal contrary to the warning on the label. Since the Act does not permit the extralabel use of medicated feeds, your actions cause the medicated feed to be unsafe to use under Section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated within the meaning of Section 501(a)(6) of the Act [21 U.S.C. Section 351(a)(6)].

You should not consider this an all-inclusive list of violations existing at your facility. As a producer of animals offered for use as food, you are responsible for assuring your overall operation and the foods you distribute are in compliance with the law.

You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to achieve prompt corrective action may result in regulatory action without further notice, such as seizure and/or injunction.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Federal Food, Drug, and Cosmetic Act. The fact that you caused the adulteration of an animal that was sold and offered for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act. Likewise, the fact that you caused the adulteration of a medicated feed that had been sold in interstate commerce is sufficient to hold you responsible for a violation of the Act.

Please notify this office in writing, within 15 working days, of the steps you have taken to bring your firm into compliance with the law. Your response should include each step you have taken or will take to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your response should be directed to Richard T. Trainor, Compliance Officer, at the following address: FDA, 300 Hamilton Ave., White Plains, New York 10601.

Sincerly,

/S/

Jerome G. Woyshner
District Director

cc: Robert Aman, Partner
(Same address)

 

-