Category: food

If You Make Food, It’s Time to Renew FDA Registration

Posted on by Patrick Morin

The Food and Drug Administration (FDA) requires all registered food facilities to renew their registration between October 1 and December 31 of each even-numbered year. The requirement applies to both domestic and foreign food facilities. If you fail to renew your registration, FDA considers the registration expired and will remove it from the account. Food facilities that sell food without a valid registration can be subject to civil or criminal penalties.

If you don’t make the food product yourself, but utilize the services of a co-packer, co-manufacturer, private label distributor or a supplier, then you may want to confirm they are in the process of renewing their registration with the renewal period. If they don’t renew their registration on time, it could lead to production delays for you. For imported ingredients, they will not be able to enter the U.S. without a valid facility registration number.

If you need assistance with registering your food facility with FDA, please contact us at Morsel Law for assistance.

Meat Recalled by Louisiana Manufacturer

Posted on by Patrick Morin

The USDA announced yesterday that Belle Rose, Louisiana based food manufacturer A La Carte Foods Properties, LLC is recalling more than 30,000 lbs of packaged ready-to-eat chicken and pork products produced since January 2017 for five restaurants in Louisiana and Texas.

Although there have not been any illnesses reported from consumption of the products, the products were manufactured without the benefit of federal inspection, which violates federal food safety regulations.

The recalled products include jambalaya, gumbo and red beans with sausage, all sent frozen in 12-pound packages. A La Carte sells more than 100 items to restaurants under its own brands, A La Carte and Southern Casual.

If your food business is facing a potential recall situation, please contact our attorneys at Morsel Law. We specialize in assisting food businesses with food safety issues in order to ensure they comply with the law and protect their brands from potential damage associated with food safety situations.

Don’t worry – tips to confidently send your food-allergic child back to school

Posted on by Patrick Morin

Quite often these days I’m asked my opinion on food allergies and how schools handle them. I’m not a doctor, allergist or a nutritionist, but for some reason people think I’m an expert on the subject because I’m a food attorney. Unfortunately for these parents, I’m not, actually far from it. But this doesn’t stop parents of children with food allergies approaching me pretty much everywhere – at social events, kids’ birthday parties, crawfish boils, etc.

While I’m well-versed in FDA labeling regulations when it comes to allergens and I’ve written on the topic before, I have little experience implementing food allergy policies in schools. However, this being said, I’ve taken an interest in this topic as of late and have spent some of my free time performing some research. Since school has begun for most (or is soon approaching for others), I thought I’d share some tips to help alleviate parents stress of sending their food-allergic child to school.

Meet with school staff

You don’t need to wait until the school year begins to set up meetings, but the key is starting early. Meet with teachers, principals, nurses and cafeteria staff. This ensures that everyone is informed and allows parents to understand how their child’s school manages food allergies. While you’re at the school, ask for a tour of the cafeteria and other places where snacks are consumed.

Create a written plan

Work with your allergist to outline all necessary information on your child’s allergy, including how to prevent accidental exposures and how to recognize and treat symptoms of an allergic reaction. And don’t forget to include your contact information. Provide your child’s teacher and the school nurse with a copy of the plan and ask for a copy to be on file with the school. Everyone who comes in contact with that child throughout the day should have a copy too.

Post pictures

Tape pictures of your child to the classroom wall that includes information on their allergies to alert anyone that comes into the room. You may also want to post one on your child’s desk, which can serve as a secondary reminder during snack time or other celebration where food is served. This is especially important when there is a substitute teacher or another parent that visits the classroom that is unaware of a student’s food allergies and doesn’t have access to the child’s action plan.

Make safe snacks

Pack allergen-free snacks for your child in case someone brings in a treat for the class. Send the snacks to school with a label specifying that they are safe, or leave some with their teacher so your child won’t feel left out during classroom celebrations.

Open and frequent communication

Make sure you regularly speak with your child’s teacher which is critical to keeping your child safe during the school year. In addition to snacks, young children are often introduced to potential food allergens through activities and crafts – sensory tables with grain products like dried pasta, children may be encouraged to build something using empty milk cartons or egg crates, or baking projects may contain an unsafe ingredient. Ask your child’s teacher to reach out to you directly if there’s ever a question about the safety of an activity or snack. Ensuring they have your cell phone number saved in their phone and feel comfortable sending you a quick text message could be imperative to avoiding a dangerous allergic reaction.

Be informed and educate

Not only should a parent be well versed in their child’s food allergy, but it is important to educate your child about their allergies in order to keep them safe when they are not with you. You will not always have control over the food your child encounters, so it is critical to help your child learn to identify safe and unsafe situations independently. Allergy alert bracelets can be a useful tool for helping adults (who may not yet understand a child’s allergies) ensure a child’s safety. You may want to also check out the website for Food Allergy Research & Education (FARE) which has great back-to-school resources.

Provide access to medications

An emergency supply of medications should always be readily available, including oral antihistamines and an epinephrine autoinjector. Whether it be the food-allergic child or a responsible adult, emergency medication shouldn’t be far away just in case.

Sending your food-allergic child to school doesn’t have to be scary. If you take the proper precautions and encourage constant and open communication with school staff, it will lead to a safe, happy school year for your child. This will give you the peace of mind knowing that your child’s needs are being met.

FDA Steps Up Enforcement of Label Violations for Food Imports

Posted on by Patrick Morin

I previously posted an article discussing the importance of accurate labeling, especially for food importers. Labeling errors are one of the most common reasons products shipped to the United States are refused entry. If a product is found to contain a labeling violation, the FDA may deem the product “misbranded,” making it a prohibited act to distribute the product in the U.S. Once the FDA identifies one mistake on a businesses’ labels, the agency is more likely to stop this businesses’ products at the border in the future.

In March 2018, the FDA refused entry to over 150 food products attempting to enter the U.S. These food products from various countries throughout the world now cannot be sold in the U.S. in their current form due to labeling violations, so now importers are faced with a difficult business decision.

There are three things importers can do with the refused products. First, they may re-label each item with FDA compliant labels. This would require the importer to design, print and affix new labels to each item refused entry within 15 days’ of receiving the refusal notice. The tight time-frame to accomplish these tasks is very difficult for smaller single-item shipments and almost impossible for larger multi-item shipments due to the manpower it would take to complete the labeling, in addition to the cost a labeling specialist will charge to expedite revised labels.

Another option is to export the products back to their port of origin or another suitable country (e.g., Canada, Mexico). While the importer would retain ownership of the products, the additional shipping cost may exceed the value of the underlying products. The last option, and usually the option of last resort, is to destroy the products while under FDA supervision. This usually occurs when the cost to re-label or export exceeds the value of the products refused entry.

FDA previously announced their intention to focus on import violations, as demonstrated by the March refusal list and their commitment to enforcing labeling laws. In order to avoid the high costs and delays resulting from a labeling violation, it is best to have food labels reviewed for FDA compliance prior to shipping the products to the U.S. The cost of such reviews are minimal in comparison to the cost of fighting to get your seized products released or exported due to a labeling violation.

If your business is unsure whether a product label is in compliance with, or need assistance in adapting your label to meet, FDA regulations Morsel Law can help. Order your flat-free label review to make sure your food label is in compliance.

FDA Label Review to Prevent Food Import Refusal

Posted on by Patrick Morin

Labeling violations are one of the leading causes of food import refusals to the United States. In fact, more than 7,000 labeling violations for food products were cited by the U.S. Food and Drug Administration (FDA) in 2017 alone.

If an imported food product is stopped by the FDA for a labeling violation they have three choices: detention, seizure or refusal of admission. None of these are good options for food importers. Know what to avoid to make sure this doesn’t happen to your business.

Below is a list of the top five labeling violations for food imports.

Nutrition information

 

More than 1,000 import refusals in 2017 were due to missing nutritional information. The FDA requires that most food and beverages are labeled with a specifically formatted nutrition facts panel. However, often import food labels include a nutrition facts panel from a foreign country. Unfortunately for the importer these panels don’t meet the FDA requirements and are therefore deemed misbranded under the law.

This will be even more important now that FDA has changed the Nutrition Facts panel to a new format. It is important to make sure you utilize the new format going forward to avoid potential labeling errors.

Ingredients

FDA requires that every ingredient included in a food or beverage be disclosed on the label in descending order of the prominence by weight. The FDA will not only review labels, but will sample products to ensure the labels are what they say they are, which is why it’s important to follow the rules when listing ingredients.

FDA regulations also require ingredients to be listed by specific  names. Imported food products, which often contain ingredients know by different names in their home country, frequently fail to list certain ingredients by the required name under FDA regulations.

Labeling in English

FDA requires that all information on labels appear in English. Labels may include other languages as well, but if a foreign language is used all of the information on the label must appear in that language as well.

Net Quantity

FDA requires a statement that provides the amount of food in a container or package. This statement must include both the U.S. and metric measurement and must be listed in the front of the package.

 

Manufacturer Name

The name and address of the manufacturer, packer or distributor must be listed on a food label. If the importer is not the manufacturer, or if the product is made for the importer, the name and address of the importer may be preceded by “Manufactured for” or “Imported by” if applicable.

 

If the FDA discovers that your food product has one of these labeling violations, the FDA will refuse entry or detain your product. This will end up costing you a lot of money and could potentially damage your relationships with buyers.

FDA is now also required to increase the number of routine inspections overseas at foreign food facilities. If a non-compliant label is found during an inspection, FDA can charge you to reinspect the facility to ensure the labels have been brought into compliance at a rate of $305 USD per hour.

Morsel Law can help assure your labels are FDA compliant through our label review service. Our experts will review and markup your labels to make sure they meet FDA regulations. Order your FDA import label review today and keep your import business running smoothly!

How to Start a Home-Based Food Business in Michigan

Posted on by Patrick Morin

So you’ve got a killer recipe for double fudge peanut butter cookies you promised your grandmother never to reveal to anyone. When you put them out at parties they disappear quicker than the Cleveland Browns chances of making the playoffs. Your friends and family have told you countless times that you could make a killing selling these cookies, but you never took them seriously. But, while recently watching your favorite showing on the Cooking Channel, you finally realize you can do what these cooks are doing and decide to launch your own cookie business. But you’ve never started a business before, let alone a food business, so where do you begin?

Since you are working with a limited budget, you rule out starting your own manufacturing facility or hiring a contract manufacturer produce the cookies for you. You narrow your options down to renting space in a shared commercial kitchen or baking out of your home. Although your friends and family rave about the cookies you give away (which they should!), you’re uncertain whether people are willing to pay for your delicious product. Based on this analysis, you decide baking in your own kitchen is the most cost effective way to go until you prove there is a market for your cookies.

Now that you’ve decided to start a home-based food business (commonly referred to as a Cottage Food business), you ask yourself: “what do I do now?” The laws and regulations governing food businesses are difficult to navigate and can seem a bit daunting, but don’t let that discourage you. In this article we will walk you through the steps to start a home-based food business under the Michigan Cottage Food Law.

Where You Can Sell

In Michigan, cottage foods may only be sold by the producer directly to the consumer at farmers’ markets, farm stands, roadside stands and similar venues. Cottage foods cannot be sold to a retailer for resale or to a restaurant for use or sale in the restaurant. Cottage foods cannot not be sold over the Internet, by mail order, or to wholesalers, brokers or other food distributors for resale. Cottage Food businesses may take orders over the phone as long as the cash transaction and delivery of the product is face to face; however, Internet orders are prohibited. Shipping or third-party delivery of cottage food products is also prohibited.

Permitted Foods

Under the Cottage Food Law, only non-potentially hazardous foods that do not require time and/or temperature controls for safety are permitted to be made in a home-based kitchen. “Potentially hazardous food” is food that can be safely kept at room temperature and do not require refrigeration. Examples of permitted foods include: Breads; Similar baked goods; Vinegar and flavored vinegars; Cakes, including celebration cakes (birthday, anniversary, wedding); Sweet breads and muffins that contain fruits or vegetables (e.g., pumpkin or zucchini bread); Cooked fruit pies, including pie crusts made with butter, lard or shortening; Fruit jams and jellies in glass jars that can be stored at room temperature (except vegetable jams/jellies); Cookies; Dry herbs and dry herb mixtures; Dry baking mixes; Dry dip mixes; Dry soup mixes; Dehydrated vegetables or fruits; Popcorn; Cotton Candy; Non-potentially hazardous dry bulk mixes sold wholesale can be repackaged into a Cottage Food product (similar items already packaged and labeled for retail sale cannot be repackaged and/or relabeled); Chocolate covered pretzels, marshmallows, graham crackers, Rice Krispies treats, strawberries, pineapple or bananas; Coated or uncoated nuts; Dried pasta made with eggs; Roasted coffee beans or ground roasted coffee; Vanilla extract (Note: these products require licensing by the Michigan Liquor Control Commission); Baked goods that contain alcohol, like rum cake or bourbon balls (Note: these products require licensing by the Michigan Liquor Control Commission).

Prohibited Foods

Potentially hazardous foods are not permitted to be made in a home-based kitchen. Examples of prohibited foods include: Meat and meat products like fresh and dried meats (jerky); Fish and fish products like smoked fish; Raw seed sprouts; Vegetable jams/jellies (e.g., hot pepper jelly); Canned fruits or vegetables like salsa or canned peaches; Canned fruit or vegetable butters like pumpkin or apple butter; Canned pickled products like corn relish, pickles or sauerkraut; Pies or cakes that require refrigeration to assure safety like banana cream, pumpkin, lemon meringue or custard pies, cheesecake, and cakes with glaze or frosting that requires refrigeration (e.g., cream cheese frosting); Milk and dairy products like cheese or yogurt; Cut melons; Caramel apples; Hummus; Garlic in oil mixtures; All beverages, including fruit/vegetable juices, Kombucha tea, and apple cider; Ice and ice products; Cut tomatoes or chopped/shredded leafy greens; Confections that contain alcohol, like truffles or liqueur-filled chocolates; Focaccia style breads with fresh vegetables and/or cheeses; Food products made from fresh cut tomatoes, cut melons or cut leafy greens; Food products made with cooked vegetable products that are not canned; Sauces and condiments, including barbeque sauce, hot sauce, ketchup, or mustard; Salad dressings; and Pet food or treats.

Limitations

Currently, Cottage Food businesses are limited to $20,000 per year in gross sales. The limit will increase again December 31, 2017 to $25,000 per year. You need to maintain sales records and provide them upon request to a food inspector.

Licenses and Permits

Under Michigan law, if you qualify to operate as a Cottage Food business, you are exempt from obtaining a food establishment license. There are no application forms to complete, no registration process and you do not need to obtain a food license or permit. However, the Cottage Food Law does not exempt you from the requirements of the Michigan Food Code, such as not distributing adulterated (unsafe) food.

Local Zoning

Home-based food businesses should be aware of local laws and ordinances, including zoning and small business permitting. It is important to check with your local health inspector to determine whether your home is properly zoned for a home-based food business.

Labeling

If your product is only sold within the state in which you operate, then you are exempt from federal labeling requirements. However, your label must comply with the labeling requirements under the Cottage Food Law.

In Michigan, your product label must contain the following:

  • Name and physical address of the Cottage Food operation (P.O. Box addresses are not allowed)
  • Name of the Cottage Food product (all capital letters or upper/lower case)
  • Ingredients in descending order of predominance by weight. If you use a prepared item in your recipe, you must list the sub ingredients as well (For example: soy sauce is not acceptable; soy sauce (wheat, soybeans, salt) would be acceptable).
  • Net weight or net volume (must also include the metric equivalent)
  • Allergen labeling (as specified in federal labeling requirements)
  • Must include the following statement: “Made in a home kitchen that has not been inspected by the Michigan Department of Agriculture & Rural Development” in at least the equivalent of 11-point font (about 1/8″ tall) and in a color that provides a clear contrast to the background (all capital letters or upper/lower case)

Hand-printed labels are acceptable if they are clearly legible, written with durable, permanent ink and printed large enough to equal the font size requirements listed above.

Below is an example of an approved label:

MADE IN A HOME KITCHEN THAT HAS NOT BEEN INSPECTED BY THE MICHIGAN DEPARTMENT OF AGRICULTURE & RURAL DEVELOPMENT

Chocolate Chip Cookies

Joe’s Cookie Company
123 Chocolate Lane
Dessert City, MI 48009

Ingredients: Enriched flour (Wheat flour, niacin, reduced iron, thiamine, mononitrate, riboflavin and folic acid), butter (milk, salt), chocolate chips (sugar, chocolate liquor, cocoa butter, butterfat (milk), Soy lecithin as an emulsifier), walnuts, sugar, eggs, salt, artificial vanilla extract, baking soda

Contains: wheat, eggs, milk, soy, walnuts

Net Wt. 3 oz (85.05g)

If you have questions about starting a cottage-food business, please contact one of our attorneys at Morsel Law.

FDA Approves Peanut Allergy Prevention Claims on Baby Food Labels

Posted on by Patrick Morin

It’s now recommended to introduce peanuts to young infants.

FDA has announced that companies will be able to label baby food products with advice about how the early introduction of peanuts in an infant’s diet may reduce the risk of developing a peanut allergy. This marks the first time the FDA has permitted a qualified health claim of food allergy prevention. These labels will be allowed on foods containing ground peanuts suitable for infant consumption, but not whole peanuts, which may be a choking hazard for young children.

The full story can be found here.

If you have questions about FDA labeling regulations, contact our attorneys at Morsel Law.

Your Organic Food May Not Be Organic

Posted on by Patrick Morin

The USDA’s Inspector General recently released its annual report on the National Organic Program (NOP). The report found widespread problems with the NOP that could result in “reduced U.S. consumer confidence in the integrity of organic products imported into the United States.” The report cites the USDA’s Agricultural Marketing Service’s (AMS) failure to reconcile organic standards between different countries, verify documents at U.S. ports of entry and conduct mandatory audits of major exporters.

In visits to seven U.S. ports of entry, the IG found produce shipments of all kinds are fumigated at the border to prevent pests from entering the country. That practice, according to the IG, runs counter to the assurance U.S. consumers get from the NOP that “foreign agricultural products maintain their organic integrity from farm to table.” The IG recommends that the NOP come up with performance measures for timely audits and suggests adoption of a schedule to review each participating country every two years.

The failure of the AMS to do their job is inviting trouble. Food fraud is big business and will probably be even more so after this report is shared across the globe. If a farmer can sell his non-organic wheat as organic for twice the price, he might consider it, or he might not. But what about a wholesale broker run by a criminal enterprise looking for new sources of income, would they think twice about reclassifying products as organic to make more profit? Probably not.

Hopefully the IG report will lead to significant changes for the NOP, but in the meantime consumers should be vigilant about identifying the source of their organic foods. Maybe you’ll think twice about spending extra money on organic food that probably isn’t organic.

If you have questions about products labeling, contact our attorneys at Morsel Law.

Label Reviews Are Critical For Food Importers

Posted on by Patrick Morin

I previously posted a similar article discussing the importance of label reviews for domestic produced products here. But a recent event reminded me to reiterate the importance of accurate labeling, especially for food importers. Non-compliant labels can cost you time, money and even your relationship with customers.

A few weeks ago, JFC International Inc. issued a voluntary recall for rice seasoning products shipped to the United States. Apparently, the recall was initiated after the company discovered the product was not labeled in English, which is required under U.S. law. Also, because the label was not in English, it is deemed to have failed to disclose allergens contained in the ingredients. Important to point out is that this isn’t JFC International Inc.’s first time being involved with a recall event; they issued a similar recall in 2016 for failing to label in English and undeclared allergens.

This event is an important illustration of how important it is to review your labels prior to shipping your products to the United States. First, one of the most common misbranding mistakes for imports is failure to label in English. This seems like a simple fix, but you would be surprised how often this occurs. Importers should require the shipper to forward a copy of the label prior to shipping to confirm compliance with U.S. law. Now this won’t stop mistakes by workers at the warehouse who load the EU labeled products onto a pallet instead of the U.S. bound product, but if you include language in your contract that makes the shipper responsible for all costs to correct the misbranding in the event the wrong product labels are attached, they will quickly change their quality control practices. This is especially true for shippers who have had to foot the bill after a container is stopped by U.S. Customs.

Second, does a voluntary recall trigger coverage under your product recall insurance policy? Generally, coverage isn’t triggered unless there is an “actual” contamination, which is usually proved by product testing or other evidence. For JCF International, if the recall was initiated for misbranding due to failure to label their products in English, the coverage would be denied. However, because the product contained “actual” allergens, then coverage would probably be triggered. But if the product didn’t contain allergens, then coverage would be denied. Even if the product didn’t contain allergens the company would still need to recall the product because it is still considered misbranded and in violation of the FDC Act, but the recall would potentially result is significant non-reimbursable expenses.

Most food label misbranding violations can be prevented through quality control measures. Importers should, if they have not already, institute best practices to minimize the risk of a potential violation that result in having to respond to FDA Notice of Action letter. These practices should also address who bears the cost and burden to deal with a misbranding violation. Prior planning can help ensure your business identifies and minimizes potential risks commonly associated with the food import industry.

If you have questions about labeling, contact our attorneys at Morsel Law.