The consent decree and permanent injunction stemmed from a FDA warning letter issued to Health One in March of 2012, which laid out serious violations of FDA regulations rules. The FDA Warning Letter can be read in its entirety here. The FDA inspected Health One’s manufacturing facility in September 2011 and found serious violations of the FDA’s Current Good Manufacturing Practice (“CGMP”) for dietary supplements. Some of the violations that Health One received included failure to perform tests to verify the identity of dietary ingredients used to manufacture the supplements, failure to establish appropriate manufacturing controls, and failure to maintain, clean and sanitize equipment. Further follow-up inspections revealed that Health One failed to correct many of the manufacturing violations initially cited in the FDA warning letter. Since Health One was in violation of the CGMP, its products were considered “adulterated” by the FDA under the Federal Food, Drug, and Cosmetic Act.

There are CGMPs for various industries, including foods, dietary supplements, drugs and medical devices. To help businesses comply with FDA regulations and manufacturing requirements and explain the rules for industry, the FDA has issued guidance documents for many industries, which can be found here.

Compliance with the FDA regulations is an increasingly difficult task for businesses and failure to comply can spell disaster for companies. In order to avoid recalls and permanent injunctions, it is very important to comply with the CGMP’s and respond appropriately to FDA warning letters. If you have any questions regarding compliance with the various CGMP’s or the Federal Food, Drug, and Cosmetic Act, please do not hesitate to contact us at contact@sglawfl.com.

Every year, countless food product recalls are caused by “undeclared allergens”, which are major allergens not listed on product labels. A list of all current recalls, including those that were recalled due to food allergen labeling issues, can be found here. For example, The U.S. Food and Drug Administration (FDA) published notification of a recent recall of vegan gingersnap cookies, which were removed them from shelves when it was found that they contained tree nuts, milk, soy, and egg, none of which were listed on the product labels and therefore the products were not compliant with food allergen labeling regulations.

Federal law requires that food producers and distributors include allergy information on their labels. The Food Allergen Labeling And Consumer Protection Act of 2004 (FALCPA) governs the disclosure of certain allergens on food labels. The FALCPA only requires disclosure of 8 major food groups on labels, although there are over 160 foods that produce allergies in humans. However, the FDA has found that over 90% of food allergies are caused by the following 8 major food groups: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. In addition, on August 5, 2013, the FDA issued a final rule regarding the labeling of “gluten free” foods, which as also authorized by FALCPA as part of the laws on food allergen labeling. As of August 2014, the FDA has started to enforce this rule, just as they do with the other 8 major food allergens.

The Food Allergen Labeling and Consumer Protection Act requires that food products be labeled in very specific ways. There are two ways to label foods containing allergens. First, the common name of the allergen can be placed in the ingredient statement. Second, the food producer can include a “contains” statement, which includes the food source from which the major food allergen is derived. For example, the food label should look like this.

The FALCPA does not apply to “cross-contact” situations that may arise during manufacturing, such as shared equipment or processing lines. Food producers are encouraged to use food allergen advisory statements, such as “may contain [allergen]” or “produced in a facility that also produces [allergen].”

When a company violates the food allergen labeling requirements of the FALCPA, they may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act. FDA may also request seizure of food products where the label of the product does not conform to FALCPA’s requirements. To avoid these heightened enforcement measures, many companies will opt to recall their products, as shown above.

Labeling your product requires intricate knowledge of many different statutes and regulations, such as FALCPA, the Federal Food, Drug, and Cosmetic Act, and the Food Safety Modernization Act (FSMA). We have previously blogged about the FSMA, food labeling, and the penalties for not complying with FDA regulations. For questions regarding food labeling and for inquiries about label reviews of your  product labels, please contact us at contact@sglawfl.com.

1. Enhanced produce safety
2. Preventative controls for human food
3. Best practices and guidelines for animal food
4. The foreign supplier verification program

The FDA is looking towards shifting its focus under the FSMA from after-the-fact responses, or a reactionary approach, to a more proactive, science-based prevention system. For example, the FDA is proposing to augment the water quality testing provisions in the produce safety rules, along with further testing of manure and compost used in crop production. The produce safety rule’s minimum applicable sales requirement, which will exempt very small farms from these new FDA regulations, is also open for public comment; right now it makes farms with less than $25,000 in annual produce sales exempt from its safety requirements.

The FSMA was signed into law in 2011 by President Obama and was the most significant food safety regulation in nearly 70 years. The FSMA seeks to promote better public health and to strengthen the nation’s food safety system. We have previously reported about the FSMA and FDA’s program priorities, including defining “gluten free,” regulating energy drinks, and establishing new rules for displaying nutritional facts.

The FSMA is a very important piece of legislation for companies to consider when developing and marketing their products. For the first time ever, under the FSMA, the FDA has the authority to recall food products. In the past, food distributors and manufacturers recalled food on a voluntary basis and through the urging by the FDA. The FSMA also calls for more frequent inspections of food and facilities. Facilities must also develop detailed preventative controls plans, which should spell out the risks to food safety, what is being done to minimize those risks, how the facility will monitor the risks, and what actions will be taken in the event of a problem.

If a company does not comply with the regulations promulgated under the FSMA, the FDA has a number of enforcement options. In addition to mandatory recalls, the FDA, under the FSMA, has expanded administrative detention of products that are potentially in violation of the law, can suspend the registration of facilities that pose a reasonable possibility of adverse health effects, and mandates increased recordkeeping for “high risk” foods. With this new authority, the FDA can suspend food facility registrations and prevent companies from producing and selling their products, like they did with a peanut butter factory in New Mexico.

The FSMA has the opportunity to change the landscape of food industry regulations. To read more about the FSMA, click here. It is important for any company in the food industry to ensure that they are complying will each new regulation. Failing to do so can mean having your company shut down. For that reason, it is important to have an understanding of your requirements under the law with respect to FDA regulations.

If you have any questions about the proposed rules, the FSMA, or compliance with other FDA regulations, please contact us at contact@sglawfl.com

In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) to help Americans avoid health risks posed by allergens. This law applies to all foods whose labeling is FDA-regulated, and it includes all domestically-produced and imported foods, including dietary supplements. Under FALCPA, any food product that contains a major food allergen or a protein derived from a major food allergen must declare the presence of such ingredient on the product’s label. Further, the eight major food allergens are defined under FALCPA as: (1) milk; (2) egg; (3) fish; (4) crustacean shellfish; (5) tree nuts; (6) wheat; (7) peanuts, and (8) soybeans. More information about FALCPA and FDA’s regulation of major food allergens in labeling may be accessed here.

If you have additional questions about food allergen labeling requirements or how you can maintain compliance with FDA labeling regulations, please contact us at contact@sglawfl.com.

After several successive recalls and months of investigation into the adequacy of Sunland’s facilities, the FDA ultimately suspended the Company’s Food Facility Registration, thereby prohibiting Sunland from producing and distributing any food products. A copy of the suspension order may be accessed here. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), any facility that manufactures, processes, packs or holds food for consumption in the United States must maintain an active registration with the FDA. The suspension of Sunland’s Registration came under the authority of § 102(b) of the recently-adopted Food Safety Modernization Act (“FSMA”). Under this provision, the FDA has authority to suspend the registration of a facility where:

the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals . . . .

Interestingly, under this provision the FDA may suspend the registration of a facility that: (1) created, caused, or is responsible for the public health issue, or (2) the packer or holder of such food, where this party either knows or has reason to know of such issue. In the present circumstances, because Sunland is the party responsible for processing these peanut butter products, the FDA’s suspension order alleged that the Company was responsible created the probability of adverse health consequences.

This suspension marks the first use of this new enforcement mechanism, which was granted to the Agency under the FSMA. Signed into law on January 4, 2011, the FSMA is frequently cited for expanding the FDA’s powers to proactively handle potential food-related outbreaks. However, with the Agency struggling to develop its regulations under the FSMA, industry has yet to observe much of this new authority in action. Thus, the suspension marks the beginning in what we may see as several “firsts” with respect to the Agency’s new enforcement capabilities.

For more information about maintaining compliance with the FSMA or FDA regulations pertaining to foods generally, feel free to contact us at contact@sglawfl.com.

Under the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), all food labels must declare the presence of major food allergens. Pursuant to FALCPA, “major allergens” consist of eight foods and food groups, including the following: milk, eggs, soy, peanuts, tree nuts, fish, crustacean shellfish and wheat. Despite FALCPA’s effective date of January 1, 2006, there remain to be countless recalls as a result of the failure to properly declare the presence of these major food allergens. While it is unclear why there have been so many deficiencies with respect to compliance with FALCPA, it appears that these types of firm-initiated recalls will continue until manufacturers and labelers can get a handle on FALCPA’s labeling requirements.

For more information about FALCPA or how you can comply with these labeling requirements, please feel free to contact us at contact@sglawfl.com.

]]> https://giannamore-law.com/listeria-laden-onions-spurs-recalls-throughout-united-states/?utm_source=rss&utm_medium=rss&utm_campaign=listeria-laden-onions-spurs-recalls-throughout-united-states Sun, 29 Jul 2012 18:44:17 +0000 http://giannamore-law.com/?p=249 On July 28, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release notifying consumers of a voluntary recall initiated by GH Foods CA, LLC. The recall covers a variety of products containing certain onions distributed by Gills Onions and shipped to various packagers and retail supermarkets throughout the United States. According to the California-based manufacturer, the recall was initiated because the onions have the potential to be contaminated with listeria monocytogenes.

The recall of Gills Onions initially commenced on July 18, 2012 but has since been expanded and prompted several other recalls of its kind. Because the recalled onions were ultimately used as ingredients in ready-to-eat foods in grocery stores throughout the country, news of onion recall spurred several others in its wake. In particular, Whole Foods Market initiated a recall of a number of fresh food items sold in the Store’s prepared food departments. According to the recall notice, found here, the recall affects the several listed prepared food items sold in Whole Foods’ 17 Florida locations only. In addition, Wegmans Food Markets, Inc. has initiated a recall of certain self-serve and ready-to-cook foods sold in three of its Pennsylvania stores. The press release detailing the Wegmans recall may be found here.

While listeria monocytogenes and its associated illness, listeriosis, may result in only minor symptoms for the general public, the infection may cause miscarriage among pregnant women and death in susceptible populations, particularly the elderly and those with weakened immune systems. For more information about listeria monocytogenes, please see our previous report here. Ultimately, no illnesses have yet been reported in connection with consumption of the recalled onions. We will continue to monitor the situation and provide further updates with respect to the foregoing recalls.

In the past, the FDA has issued statements to consumers and industry concerning the presence of undeclared active ingredients in dietary supplements, and with the recent recall it appears that this issue remains a high priority for the FDA. For more information about maintaining compliance with FDA regulations, contact us at contact@sglawfl.com.

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In 2004 Congress passed the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), thereby giving the U.S. Food and Drug Administration (“FDA”) the authority to regulate in this area. Since the passage of FALCPA, the FDA has developed regulations requiring labelers to identify the “major food allergens” in product labeling. The eight major food allergens, as defined by FALCPA are: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.

Under FDA regulations, any of these foods, including ingredients derived from them, must be listed in accordance with food labeling rules. If manufacturers and/or packagers of foods do not comply with these labeling regulations and such non-compliance is discovered, the FDA may take action against a firm. Additionally, non-compliant firms may voluntarily issue recalls of affected goods to dissuade the FDA from taking further enforcement action. For more information about recalls of this type and food allergen information, please see our previous reports here and here. In conjunction with FAAW, the FDA has provided consumers with an overview of food allergen issues, which may be accessed here.

Under the Food Allergen Labeling and Consumer Protection Act and its corresponding FDA regulations, manufacturers and/or labelers of finished food products are required to declare the presence of major food allergens in labeling. “Major food allergens” include the following ingredients and the derivatives thereof: milk, egg, fish, shellfish, tree nuts, wheat, peanuts and soybeans. In the present case, the presence of an undeclared milk derivative caused Jonlly to run afoul of FDA regulations, necessitating this recall by the company.

Recalls of this type are not infrequent. In April 2012, we reported on a similar recall that was initiated as a result of undeclared milk and/or nuts. Despite being common, these recalls are preventable. Compliance with the laws and regulations pertaining to labeling is critical to ensure the seamless distribution of all FDA-regulated products. For more information about labeling requirements, please contact us at Contact@Giannamore-Law.com.