Category: Uncategorized

Safe Treats

• Give your child a good meal before trick-or-treating to prevent them from snacking on candy and treats. Urge them to wait until they get home before eating them and let you inspect the treats in their bags.
• Tell children not to accept – and especially not to eat – anything that isn’t commercially wrapped.
• Inspect all treats for signs of tampering, such as an unusual appearance or discoloration, tiny pinholes, or tears in wrappers. Throw away anything that looks suspicious.
• Parents of very young children should remove any choking hazards such as gum, peanuts, hard candies or small toys.
• Consider providing non-food treats for children that visit your home, such as coloring and activity books

Halloween Parties

• Unpasteurized juice or cider can contain harmful bacteria such as Salmonella. To stay safe, always serve pasteurized products at your parties.
• Don’t taste raw cookie dough or cake batter that contain uncooked eggs
• Keep all perishable foods chilled until serving time. These include finger sandwiches, cheese platters, fruit or tossed salads, cold pasta dishes with meat, poultry, or seafood, and cream pies or cakes with whipped-cream and cream-cheese frostings.
• Don’t leave perishable goodies out of the fridge for more than two hours (one hour in temperatures above 90°F).
• Bobbing for apples is a favorite Halloween game. Reduce the number of bacteria that might be present on apples and other raw fruits and vegetables by thoroughly rinsing them under cool running water. As an added precaution, use a produce brush to remove surface dirt.
• Try a different bobbing for apples game from FightBAC.org. Cut out apples from red construction paper. Write activities for kids to do on each apple, such as “say ABCs.” Place a paper clip on each apple and put them in a large basket. Tie a magnet to a string or make a fishing pole with a dowel rod, magnet and yarn. Let the children take turn “bobbing” with their magnet and doing the activity written on their apple. Give children a fresh apple for participating in your food-safe version of bobbing for apples.

FDA medical device classification involves placing items into certain categories according to how safe they are. This is very important to the health care industry because the lives of those affected by these devices should be protected. There are certain things that are looked at when placing these items into various categories.

The complexity of the design is one factor that is considered. Some items are designed in a very simple manner and are used for basic procedures while others are more complex, such as toothbrushes. Something that is simple in design might not cause much concern. This is classified as a Class I device But, it will still be subject to general controls, and this is a class I category.

These general controls include keeping an eye on items that are adulterated and devices that are banned. The devices which are placed under general controls are not used to support life and they are usually not a threat to one’s health. An example of this is gloves that are used for examination and bandages.

When there are general controls in addition to special controls, this is a class II category. These are devices that are subject to greater standards than those of a class I category. They have to perform in the way they are designed to perform without injuring the user or the patient. An example of this is a powered wheel chair. Class II medical devices require pre-market clearance from FDA. This clearance requires submission of an application referred to as a 510(k).

The next category is class III and this means that in addition to general controls, there is a need for scientific review of these items. These devices are usually used to sustain life or support it in some way. This means that there is the potential to harm the patient if the item is misused. An example of this would be a pacemaker. Class III also requires pre-market clearance in the way of a PMA.

FDA Consultants, especially those welled versed in the regulations, such as attorneys, are best equipped to help maneuver the regulatory issues of FDA for medical devices. An FDA Consultant who has conducted 510(k) applications will be able to assist you in drafting the applications and ensuring that the necessary testing and paperwork is complete before submission.

OTC drugs are the most common forms of self-medication in the US. Since they are offered over the counter they do not require the client to present a doctor’s prescription. Some people argue that this might be a rather unsafe procedure since after all these products are still drugs which need to be taken with care. However there are a number of processes and systems which are used to make such a request legal and safe. One such procedure is the FDA registration for OTC drugs.

Basically the FDA oversees the types of drugs which are allowed to be purchased over the counter. This regulatory body ensures that the products which fall in this category are relatively safe and can be purchased without a prescription.

The regulatory structure for FDA registration of OTC drugs mainly depends on the type of ingredients, the quantity of the active ingredients, and the labeling the particular product is composed of. In fact a study is carried out for each product so as to come up with the drug monograph. This will govern the FDA’s decision as to whether to register that particular product as an OTC.

Furthermore, there are a number of other regulations which need to be complied with prior to filing FDA registration and while marketing the OTC drug.

An OTC drug which has a monograph requires that the manufacturer comply with all aspects of the monograph as well as filing FDA registration through FDA’s online system. In this application the manufacturer will delineate various aspects relating to the particular product, including active ingredients, inactive ingredients and labeling of the product.

FDA registration also requires annual renewal of registrations to keep track of which products are still in the US market. The regulatory framework for OTC drug FDA registration can be cumbersome and difficult to maneuver. Hiring an attorney well versed in the FDA registration process is vital to ensure compliance with FDA regulations.

When it comes to football, defense matters. When it comes to planning a tailgate party, a good defense against foodborne illness matters even more.
“This year, we’re urging fans to follow the food safety play book at the tailgate parties they host,” USDA Under Secretary for Food Safety Dr. Elisabeth Hagen said. “Large gatherings can increase the chance of becoming ill, but by following these rules all fans can enjoy the game and their food, safely.”

Illegal Use of Hands

Avoid penalties for “illegal use of hands.” Unclean hands are one of the biggest culprits for spreading bacteria, and finger foods are especially vulnerable. Chefs and guests should wash their hands with soap and warm water for 20 seconds before and after handling food. If running water is located far away from your tailgate, have sanitizing wipes available throughout the day. Also, be sure to clean eating surfaces often, and wash serving platters before replenishing them with fresh food.

Offsides

Think of your tailgate fare as two different teams—uncooked versus ready-to-eat foods. Prevent “encroachment” at all costs and keep each team in its own zone. The juices from raw meat can contain harmful bacteria that cross-contaminate other food. Use one cutting board for raw meat and poultry and another one for cutting veggies or foods that will not be cooked. If you use only one cutting board, wash it with hot soapy water after preparing each food item. As you take cooked meat off the grill, be sure to place it on a clean platter, not on the dish that held it while raw. The juices left on the plate from raw meat can spread harmful bacteria to safely cooked food.

Equipment violations and holding

Call a “time out” and use a food thermometer to be sure meat and poultry are safely cooked. Remember that internal temperature, not meat color, indicates doneness. To be sure harmful bacteria are killed, whole cuts of fresh beef and pork should be cooked to 145 °F followed by a three minute stand time, while ground beef and pork should be cooked to 160 °F (no rest time is necessary). Ground, whole, or pieces of poultry, as well as casseroles, should be cooked to 165 °F. Hotdogs and reheated deli meats should be cooked to 165 °F or until steaming hot.
“Holding” may be one of the most likely offenses your referee encounters during long football games. Never hold perishable foods out for more than two hours, or for more than one hour if the temperature is above 90 °F. Put leftovers back in the cooler promptly to block offensive bacteria from multiplying. When in doubt, throw it out of the game—and your tailgate.

False start

When it comes to foodborne illness, there is no opportunity for an instant replay. To avoid these infractions, make sure you understand the rules completely. One of the best resources available before kickoff is USDA’s virtual representative, “Ask Karen.” Food safety coaches are available Monday through Friday from 10 a.m. to 4 p.m. ET on the “Ask Karen Chat” and by phone at the USDA’s Meat and Poultry Hotline, 1-888-MPHotline (1-888-674-6854). Recorded messages are available 24 hours a day.

Food that is bought, sold, and imported in the United States needs to have a label, ingredients that are permissible, food facility registration. Many companies do not have the expertise and skills in creating labels, so they hire a FDA consultant in order to keep within compliance of the regulations. There are five reasons why businesses should hire a consultant when they are dealing with food labeling under FDA regulations.

Compliance Process

When businesses create a new product for the public, they often do not understand what the details are in order to ensure their product is compliant with regulations. Using consultants will make it easier to get their product approved since they know all of the details in labeling.

Protecting the Company

By hiring a consultant, he or she is aware of the legality issues on how a new product needs to be labeled. The consultant will be preventing any potential lawsuits to the company by complying with the FDA regulatory guidelines for the labels. Consultants also are the ones to confirm that all procedures were followed if a consumer issues a compliant.

Staying in Compliance

When designing the label, the consultant is aware of all of the FDA laws and guidelines that are needed in order to be within compliance. The experts have the knowledge and expertise to word the label correctly while staying within the FDA guidelines. The consultant is also there to ensure that the business operates within the laws if an auditor of the FDA stops by.

Required Health Information

The experts will know what type of health claims may or may not be required and/or allowed on the packaging. They know where and when to put the nutrient information on the packaging as well. If a product contains allergens, the consulting firm needs to know how to word it on the label correctly in order to prevent injury to the customer.

Staying Informed

The FDA Consultant also keeps up to date with any new laws or guidelines that are released on a yearly basis. They know how to stay on top of the changes by going to seminars or taking self study courses. This is to ensure that the data on the labels remains within the guidelines of food labeling under FDA regulations.

As you may already know Import Alerts, or FDA’s automatic detention lists, can cause serious issues for your clients. Import Alerts are also known as detention without physical examination. An importer that finds itself or its products listed on FDA’s Import Alert lists faces the difficult task of proving to FDA’s officers that its products are in compliance. Proof can come in a variety of methods, but the common approach is through a private laboratory test. These tests can become quite costly when the importer must conduct them every importation.

What is the best course of action for these importers? How can your client get off this list in hopes of smoother, quicker importation of their products? There are a number of steps that need to be taken by these importers. This is a guideline to help them move in the right directions so that the product and/or company can be removed from the list.

The first step is to determine what was wrong with the product that resulted in the original Import Alert being issued. The type of issue will dictate the best manner and means of resolving the issue. The issue must be resolved, whether it is a labeling concern or an ingredient issue. The necessary steps to resolve the issue and ensure that it does not happen again must be documented, preferably in newly enacted company protocols that must be followed by employees.

Once the issue has been addressed and new procedures have been implemented and documented to ensure that the issue does not occur again then the importer must make entry. The product will be detained automatically by FDA and a hold designation will be issued. At this point it is up to you, as their customs broker, or an attorney retained by your client, to communicate with FDA and request that the product be allowed to be sent out for private laboratory testing. The testing facility must be approved by FDA and the manner and means of collecting samples must be in accordance with FDA standards. It is imperative that the correct laboratory be chosen. If the sampling method is done incorrectly, or the method of testing is not industry standard, then the product will not be released and another sample will have to be sent for testing.

After the first successful testing and release the importer must bring the product in four more times, for a total of five shipments. Each shipment must be tested and released. Finally, after five successful releases a petition may be submitted to FDA’s Division of Import Operations & Policy for consideration of removal. Once the petition is granted your client will be removed from Import Alert and detentions without physical examination will be a thing of the past.

Under the FDA food law known as the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 food facility registration is required to certain food facilities as well as providing FDA advanced notice of shipments carrying imported foods. Under the food laws domestic and food facilities that manufacture, process, pack or hold food for human or animal consumption must provide a FDA registration.

Foreign FDA registration is required in specific instances depending on what process of manufacturing is occurring in the particular facility. There are situations where the “primary” facility must register and there are situations where both the primary and secondary facilities must register.

Foods that are included and result in the requirement of food facility registration include dietary supplements, beverages, infant formulas, fruits and vegetables, dairy products, raw agricultural commodities, bakery goods, and many more. There are also a few exclusions as to what foods require FDA registration.

Foreign facilities must designate a US agent, who maintains a location in the US and is physically present in the US.

The purpose of the facility registration requirement is to provide FDA with the location and source of potential bioterrorism incident or an outbreak of food-borne illness as well as allow FDA to quickly notify any facilities that may be affected.

Failure to register is prohibited under US regulations. The federal government may bring a civil action, or it may bring a criminal action to prosecute persons who are responsible for the commission of a prohibited act. Furthermore, a foreign facility that fails to register will not be able to pass US Customs. The food product will be detained by FDA or Customs and Border Protection Services.

The repercussions of failing to register are widespread and can have a direct impact on your company’s ability to conduct business. Be sure your facility is registered before going to market.

Under the FDA laws a cosmetic is defined by its intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance. A drug on the other hand is defined a “(a) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…and (b) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Do you know what your product is classified as?

Many distributors and manufacturers do not realize that a moisturizer is a cosmetic, but the moment an ingredient to is added for sun protection the product is now a combination product, cosmetic/over-the-counter drug. The implications of being a drug versus a cosmetic are widespread. For example, a cosmetic does not require FDA registration. However, an over-the-counter drug requires facility registration, labeling submission and what is known as a national drug code number provided by FDA.

The time involved in obtaining the necessary FDA registrations for an over-the-counter drug can be lengthy. This is why it is imperative that a distributor or manufacturer have their product reviewed before going to market, to ensure compliance with all applicable regulations.

Moreover, the statements made on a cosmetic’s labeling may subject it to classification as a drug. One example is claims regarding diseases. A product, regardless of how it is marketed, that claims to assist with a disease, say rosecea, will be considered a drug for purposes of FDA laws.

An attorney whose practice focuses on FDA matters and international trade can be a vital component. FDA attorneys are qualified to interpret regulations to ensure that the claims being made are compliant while still being able to market the product.