Compliance Resources to Help you Stay Current

At the request of the US Food & Drug Administration (FDA), the US Department of Justice filed a com-plaint on Jan 13, 2011 against Mystical One LLC, Jamaica, NY, a beverage company.  The complaint sought a permanent injunction to prevent the company from processing and distributing juice and other products.  

According to the department, Hank J. Hagen and Milton S. Reid and their company violated the Federal Food, Drug, and Cosmetic Act by not putting in place a Hazard Analysis and Critical Control Point (HACCP) plan for some juice products like carrot juice.  The company also failed to comply with current Good Manufacturing Practice (cGMP).

FDA requires juice processors to implement HACCP plans so they can identify and control food hazards associated with the juices.  Towards this end, all food manufacturers are required to comply with cGMP.  The FDA has not come across any instance of illness arising from the consumption of Mystical One’s juice products though.  Important amongst the violations cited by the FDA are the company’s failure to:
 

• adequately heat low-acid vegetable juices.  As a result, dangerous micro organisms are neither destroyed nor prevented from growing
• properly clean food-contact surfaces
• ensure perfect sanitation conditions at the facility to prevent sources of possible food and water contamination

Such failures could lead to the formation of clostridium botulinum bacteria that can germinate in the carrot juice manufactured. When consumed even in very small quantities, paralysis, difficulty in breathing and death from asphyxiation could result. In 2006, six cases of botulism were linked to refrigerated carrot juice in the US and Canada.

Regulations

cGMP provisions apply to making, packing, or holding human food.  When manufactured in contraven-tion of HACCP or GMP provisions, the law defines these beverage products as adulterated products.  

Sources:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239965.htm

Tropical Nut & Fruit of Charlotte, NC, has issued a nationwide recall of all its products containing walnuts supplied by Atlas Walnuts, LLC after November 16, 2010.  Possible salmonella contamination prompted the action. The voluntary recall was initiated when Atlas Walnuts, LLC recalled its product after learning that one of its customers tested positive for salmonella. Atlas conducted additional Salmonella tests on the same product lot and the results were negative.

Tropical Nut & Fruit of Charlotte, NC has not received any consumer illness complaints from the consumption of the products. The nationwide recall was initiated by way of abundant caution. Consequently, it is withdrawing the affected products from retail store shelves and the entire distribution system. Consumers should return the products to the store concerned for a full refund.

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Occasionally, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. 

Regulations

Manufacturers of defective products voluntarily carry out most recalls. Alternatively, the FDA may identify a defective product and instruct the company concerned to recall the product. If the company does not recall the product, the FDA can seek legal action under the FD&C Act.  These include seizure of the available stock of the product, and/or injunction of the firm, including a court-directed recall of the product. FDA guidelines that companies should follow while recalling defective products are published in Title 21 of the Code of Federal Regulations, Part 7.

Source:

http://www.fda.gov/Safety/Recalls/ucm236656.htm

http://www.fda.gov/Safety/Recalls/ucm165546.htm

Tessalon (benzonatate) is an FDA-approved symptomatic cough relief drug for patients older than 10 years. However, this drug may attract younger children because of its candy-like appearance (round, liquid-filled gelatin capsule). The safety and effectiveness of benzonatate in children younger than 10 years has not been established. The FDA has therefore warned that accidental ingestion of Tessalon by children younger than 10 years can lead to serious side effects or even death.

Zonegran is an FDA approved anti-epileptic drug, manufactured by the Irish company, Elan Corporation PLC. However, Elan and its U.S subsidiary promoted Zonegran for a variety of improper uses, including mood stabilization, migraine headaches, eating disorders and weight loss. It amounted to illegal promotion of the drug.  The Justice Department slapped a fine of USD 203 million plus on Elan Corporation PLC and its U.S. subsidiary under the False Claims Act. The Japanese drug marketer Eisai Inc., which bought the drug from Elan, will pay USD 11 million for off-label marketing of Zonegran.

Elan has consented to plead guilty and pay a criminal fine of USD 97 million and an additional USD 102.3 million to resolve civil allegations. It will forfeit assets worth USD 3.6 million too. The settlement demonstrates the government's determination to curb health care frauds by invoking the False Claims Act. The Justice Department claims to have recovered USD 5 billion plus since January 2009 in cases involving fraud against federal health care programs alone.

Regulations

The False Claims Act (31 U.S.C. § 3729–3733, also called the "Lincoln Law") is an American federal law that allows civilians to file complaints against federal contractors for filing fraudulent claims against the government. The act of filing such complaints is informally called "whistleblowing." Individuals filing under the Act stand to receive a portion (usually 15 to 25%) of any recovered damages. The Act provides a legal tool to counteract fraudulent billings turned in to the federal government. Claims under the law have been filed by persons with insider knowledge of false claims involving health care, military, or other government spending programs. The government has recovered nearly USD 22 billion under the False Claims Act between 1987 and 2008.

Source:  

http://www.pharmpro.com/news/2010/12/business-Elan-to-Pay-203M-Off-Label-Marketing-Fine/

http://en.wikipedia.org/wiki/False_Claims_Act

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., has voluntarily recalled all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews distributed in the United States. The recall was issued after the presence of foreign materials in the product, including metal and wood particles, was reported. The company’s investigations have led it to conclude that the materials possibly found their way into the product during its manufacture at a third party facility. The FDA has since suspended production of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews even as its own investigations into the matter continue. Production will resume once corrective actions are implemented. This recall was conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Although the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare has advised consumers not to use the product by way of abundant caution. In particular, consumers who have medical concerns or questions should contact their healthcare provider.

Regulations

The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. The U.S. Food and Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203). It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It is designed to discourage the sale of counterfeit, adulterated, misbranded, sub-potent, and expired prescription drugs. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded drugs from the market.

Source:  

http://www.fda.gov/Safety/Recalls/ucm236715.htm

http://en.wikipedia.org/wiki/Food_and_Drug_Administration

FDA has released its Guidance Agenda for 2011 - it has been published in the Federal Register. The agenda functions as a Guide to Guides. The agency is not bound to adhere to the schedule. Thus, the Guidance on the Internet and Social Media is listed in the 2011 agenda although it figured in the 2010 agenda.  This throws up the following two possibilities:

• The draft guidance that the Division for Drug, Marketing and Advertising (DDMAC) hoped to release by the year-end may not be released. There was always a suspicion that some elements of the release were outside the jurisdiction of DDMAC
• More than one draft guidance could emerge.

In fact, a two-day public meeting in November 2009 covered the topic in detail and many believed that the draft guidance would not address the issues that emerged at the said meeting.  At best, multiple guidances divided among different subject matter jurisdictions might emerge. 

“Comparative Claims in Drug Promotion”, and “DTC Television Advertisements – DTC Pre-Review Program” figure under the category “Advertising” in addition to the guidance on “Promotion of Prescription Drug Products Using Social Media Tools”. 

By way of clinical trial designs, topics are slated for “Non-inferiority Trials” and “Adaptive Trial Designs”. Considerable activity is allocated for tobacco given FDA’s new authorities in this area.   However there is no suggestion of creation of a regulatory pathway for biosimilars. 

Regulations

The Food and Drug Administration (FDA) publishes its annual guidance document agenda. This list is published under FDA’s good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones. The general public can submit either electronic or written comments on this list and on any agency guidance document at any time.

Source:

http://www.eyeonfda.com/eye_on_fda/2010/12/fda-publishes-guidance-agenda-for-coming-year.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+eyeonfda/

http://edocket.access.gpo.gov/2010/pdf/2010-30623.pdf

http://en.wikipedia.org/wiki/Food_and_Drug_Administration_Modernization_Act_of_1997

The FDA has been uncovering a number of harmful products marketed as dietary supplements for weight loss, body building and sexual enhancement. These products actually contain undeclared, active ingredients present in FDA-approved drugs or variations thereof. The FDA has caused the recall of nearly 200 inappropriately-formulated products since 2007. The recalled products were linked to reports of stroke, kidney failure, liver injury and death.

Brinkman Turkey Farms Inc. of Findlay, Ohio, recalled Brinkman's Gourmet Barbecue Sauce Jars (22 oz, 40 oz, 160 oz) bearing the codes, UPC# 033244000215,UPC# 033244000222 and UPC# 033244000208 from distribution. These products were distributed to retail stores, distribution centers and consumers in Ohio, Wisconsin, Michigan, Illinois, and Iowa. The recall was initiated because the product contained milk and soy distributed in packaging that did not reveal the presence of these ingredients. Milk and soy can cause serious to life-threatening reactions in individuals allergic to them.

Tessalon (benzonatate) is an FDA-approved symptomatic cough relief drug for patients older than 10 years. However, this drug may attract younger children because of its candy-like appearance (round, liquid-filled gelatin capsule). The safety and effectiveness of benzonatate in children younger than 10 years has not been established. The FDA has therefore warned that accidental ingestion of Tessalon by children younger than 10 years can lead to serious side effects or even death.

In recent years, the FDA has uncovered a number of harmful products marketed as dietary supplements for sexual enhancement. These products actually contain active ingredients present in FDA-approved drugs or variations of these ingredients. Sexual enhancement supplements promising rapid or long-lasting effects are likely to contain the latter. The FDA has been urging consumers who have experienced negative side effects from such sexual enhancement products, to stop their usage and seek help from a health care professional.

Pablo's Produce, Inc. of Oxnard, California, has voluntarily recalled one lot of cilantro bearing UPC # 03383801049 and sold between Nov 24, 2010 and Dec 2, 2010. The cilantro had been bundled with white twist ties, with the word "Cilantro" printed in black and the name of the supplier, "Pablo’s Produce of USA" printed in red and green.

The cans of chicken salad bear the establishment number "P-169" inside the USDA mark of inspection and the lot code "0225XXQBC". The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) re-issued Recall Release RC-064-2010, upon receipt of additional information from the recalling firm to correct the "Best-by" date so consumers can confirm they no longer possess the recalled products. This is a Class II recall where there is a health hazard situation with a remote probability of adverse health consequences from the use of the product.
 

Lobby Shoppes, Inc. has recalled three of its products, Gourmet Cheese Popcorn (12 oz. bags and 24 oz. bags), Chicago Triple Mix Popcorn (12 oz. bags) and Caramel Corn (2 ½ lb. bags, 4 lb. bags, and 9 oz. tubs) because they contained undeclared ingredients like milk and soy, which can trigger serious allergies in susceptible individuals.

The FDA has issued a warning letter to Align Technology Inc., a company that makes a popular teeth straightener, the Invisalign system, on its failure to report information about patient side effects. The warning letter accused the company of failing to comply with FDA requirements to report serious side effects associated with medical devices. It cited some patient complaints about allergic reactions to the Invisalign trays such as swollen lips and mouth ulcers.

McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc., has initiated, in consultation with the FDA, a recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package, distributed in the United States.

McNeil Consumer Health care, Division of McNeil –PPC, Inc., in consultation with the U.S Food and Drug Administration (FDA) has recalled certain products. This is a voluntary recall of the following products:

All product lots of Children's BENADRYL® Allergy FASTMELT® Tablets (in Cherry and Grape Flavors) distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas.

Intelli Health Products has announced the inclusion of all lot codes in its voluntary nationwide recall of Duro Extend Capsules for Men.

California Firm, Diana’s Mexican Food Products, Inc. has announced the recall of around 41,670 pounds of chicken tamales. The recall was triggered due to the presence of an undeclared allergen, whey. The company had not declared the same on the label.

McCormick & Company, Incorporated (NYSE:MKC), with the knowledge of the Food and Drug Administration (FDA), has issued a voluntary recall of Golden Dipt® Fry Easy All-Purpose Batter, 10 OZ, having the UPC Code 4123470111 and to be used by NOV 17 11 AH as a limited number of packages of the product possessing this date code are said to contain an egg ingredient which does not show on its label.

The fresh&easy™ Ginger Spice Cookie Dough (16 oz.) is being voluntarily recalled by the Fresh & Easy Neighborhood Market. This comes with the alert of undeclared peanuts, which could prove a grave risk to those individuals allergic to it, if consumed by them.