Business Law Review Journal

Please welcome today’s guest blogger Wade Coye

Arbitration is a form of alternative dispute resolution, through which individuals or parties attempt to settle a discrepancy outside of court, rather than through litigation. An impartial third party, often called an arbitrator, is selected to hear the evidence and testimonies of both sides and then determine an award. The term “binding,” in “binding arbitration,” means that all parties involved agree that the arbitrator’s decision is final.

In 1925, the Federal Arbitration Act, which is found in Title 9 of the U.S. Code, was enacted with the intention of resolving disputes between parties in a fair and quick manner with little to no room for appealing the decision. In litigation, there is a judge and jury and there is a judgment. But in arbitration, there is an arbitrator and there is an award. The parties involved in the dispute agree that the arbitrator’s decision is final and they give up the right to appeal the decision to a court. Arbitration lawyers realize that this may sometimes present problems in an individual’s case.

Arbitration may sometimes be a quick and necessary means of resolution. For example, if two parties-employee and employer, or consumer and corporation-both agree that arbitration is the optimal method of resolving any issues, then it could theoretically solve a dispute in a quick and preferred manner. But some people believe that it limits a consumer’s rights. Binding arbitration may not always be the fairest system it appears to be, especially in the 21st Century where terms and agreements (which may be up to 25 pages or more of legalese) can be agreed and confirmed in one simple click of a button. People may not realize what they’re getting themselves into.

Whether it’s an employee signing a contract to work for a new employer or a consumer signing an agreement with their cell phone provider, there may be a binding arbitration clause written in it. So if an issue eventually arises and arbitration is the only option, who chooses the arbitrator? Who appoints the one making the final decision? Most likely the party requiring the arbitration in the first place will. That’s where the situation gets complicated. The arbitrator may be third party, but are they really impartial? They could be, but they might have a bias toward the one who appointed them. That party is, after all, the one supplying the arbitrator with work. You would hope that everyone would act impartially and in an unbiased manner, but bias is ingrained in arbitration from the beginning. In litigation, there is a scrutinizing process known as voir dire by which jurors are questioned to determine that they are as unbiased and impartial as possible, but in arbitration the selection process is usually a little quicker and not nearly as in-depth. Although, arbitration laws may be different from state to state, and their requirements may differ.

Supporters of arbitration might point out that arbitration, in general, saves the courts time and money. And when mixed with its supposed efficiency, supporters may likely tout it as a favorable approach to alternative dispute resolution. But those opposing arbitration might most likely point to the questionable nature of the decisions made. The parties involved in arbitration are bound to the decision of the arbitrator and the determined award. Just like if you sign a contract with an insurance company for auto insurance, health insurance, or homeowner’s insurance, you should pay close attention to the contract and agreement. You may be limiting yourself to binding arbitration if there are any disputes down the road.

It may be a quick avenue of resolving disputes between parties and some may see it as preferable to the longer process of litigation, but binding arbitration may also involve waiving one’s rights to access the courts. It should never be considered lightly. As its name implies, it is a binding agreement, and individuals and parties must agree that the arbitrator’s decision is final.

Please welcome today’s guest blogger Jim Radogna

It was bound to happen. The tremendous growth of digital marketing and social media was an invitation for government regulation. For instance, the Federal Trade Commission recently updated its truth-in-advertising guidelines, which were last revised in 1980, to address the commercialism of the Web. Federal and state regulators are taking the position that social media is not a loop-hole for deceptive marketing practices and are actively enforcing and cracking down on social media deception. Proper social media ethics are now a matter of law, not just personal preference.

Faking Reviews

The FTC’s updated Endorsement and Advertising Guidelines require companies to ensure that their posts are completely accurate and not misleading, and planting or allowing fake reviews is a violation. The Guidelines are extremely broad and can apply to anyone writing reviews on rating sites, web sites or promoting products through social media sites, including blogs.

There are several companies out there that offer seemingly quick and easy ways to improve your ratings on review sites. Be careful! A Dealership in Texas suffered devastating reputation damage because of the review-posting practices of a company they hired. A customer discovered that suspicious “reviewers” were writing 5-star reviews about all kinds of businesses and dealerships across the nation on the same day. This debacle was uncovered in October of 2010, yet news stories continue to show up on the dealer’s page one search results.

While the above case may be an example of a dealer who unfortunately hired the wrong vendor, an area of real concern is the activity of a company’s own employees. The FTC recently charged a California marketing company with deceptive advertising after it found that the company’s employees were posing as ordinary consumers posting positive reviews online.

Dealers may face liability if employees use social media to comment on their employer’s services or products without disclosing the employment relationship. The FTC requires the disclosure of all “material connections” between a reviewer and the company that is being reviewed. These connections can be any relationship between a reviewer and the company that could affect the credibility a consumer gives to that reviewer’s statements, such as an employment or business relationship. So if employees, friends, family or vendors post reviews to prop up a dealership’s online reputation, they must clearly disclose any relationship they have with the company. In addition, all reviews must be an honest opinion based on a real experience. Reviewers must never endorse a product or service that they have not used personally or create any other form of false endorsement. It’s all about transparency and full disclosure.

Besides the obvious potential damage to a dealer’s reputation, failure to follow these regulations can result in substantial penalties. In recent actions, the New York Attorney General fined a cosmetic surgery company $300,000 for ordering its employees to write fake reviews of its face-lift procedure and the FTC ordered a company marketing instructional DVDs to pay $250,000 for fake reviews posted by the company’s affiliate marketers. The FTC has indicated that companies are fully responsible and liable for all inappropriate actions of their employees, their vendors, and any advocates they recruit. Reviewers may also be held personally liable for statements made in the course of their endorsements.

Paying For Reviews

The practice of offering a free oil change or gas card to a customer in exchange for a good survey has long been frowned upon by manufacturers. Because there are no factory gatekeepers when it comes to online ratings, it may seem tempting to offer customers an incentive to post a positive review. The good news is that you can if you want to; the not-so-good news is that the regulations require that any reviewer provided with any form of compensation such as free services, rewards, incentives, promotional items, gifts, samples, or review items, must fully disclose the source and nature of any compensation received.

So, if you pay for reviews and the reviewers fail to disclose their compensation, you may face liability. This is an area where it’s easy to get caught and besides the legal danger, your reputation will likely take a big hit.

Advertising on Social Media Sites

The wisdom of trying to “sell” on social media sites by posting inventory, prices, or payments is an ongoing debate, but the fact remains that many dealers are engaged in this activity in some form. While I have no opinion on the relative merits of whether to “sell or not to sell” on social media, it’s important to note the potential implications of these types of activities.

Despite the fact that social media tends to be a low-keyed, casual type of communication, advertising regulations don’t go away. In fact, The Federal Trade Commission recently announced that it was updating its document Dot Com Disclosures: Information About Online Advertising. The primary focus of the document, which was first issued in 2000, is to inform advertisers that consumer protection laws and the requirement to provide clear and conspicuous disclosures applies to the online world in addition to the offline world.

So, in a nutshell, if inventory is posted or prices/payments are quoted on social media it’s likely that the posts will be deemed to be advertisements and will be subject to state and federal disclosure and truth in advertising regulations. Lack of space is no excuse either. Even if you’re advertising on Twitter and limited to 140 characters, you must include a clear link to any necessary disclosures. A good rule of thumb is to have any information that could possibly be construed as advertising reviewed by upper management or a qualified professional before it is posted.

Social Media Policy

Social media applications such as blogs, social networking, and video sharing have soared in popularity so it’s important that dealers control the information that’s coming out of their business. Policies and procedures should be put in place to spell out how employees are expected to conduct themselves within social media. A social media policy can help take the guesswork out of what is appropriate for employees to post about a company to their social networks.

There are a number of potential legal issues with employees’ use of social media that should be addressed such as the danger of possible privacy, harassment, discrimination or defamation claims. Beyond legal risks, employees can harm a company’s reputation by disseminating controversial or inappropriate comments regarding the employer. However, employer restrictions on the use of social media can be tricky. The National Labor Relations Board (NLRB) recently issued a complaint against an Illinois dealership, alleging that the dealership unlawfully terminated an employee for making critical comments about the dealership on Facebook. While some unprofessional and inappropriate conduct may not be protected, the intersection of social media and the NLRA is an evolving area of the law.

The best way to protect your dealership from legal trouble is by establishing formal social media policies for your staff. Companies often get in the most trouble when they fail to train their employees about appropriate social media use and disclosure. To prevent this from happening, it’s a good idea to create a written social media policy and training program for your company and carefully monitor social media use.

There are a number of laws that have been created in order to protect both mental healthcare professionals, the patients they treat, and the general public. Some very important laws that were created are the duty to protect and the duty to warn. These particular laws were created to prevent those who notify a mental health professional that they want to hurt themselves or others from doing so.

Although confidentiality is an important part of treatment, cases where a patient tells a professional that they want to hurt themselves or others are not covered by confidentiality Another part of the law surrounding duty to protect is duty to warn.

Duty to warn is used to protect others from someone who has expressed that they wish to hurt another person. A mental health professional who is told by their patient that the patient feels like hurting themselves or others is legally required to notify the proper authorities to prevent the patient from hurting themselves or others. If the patient has expressed that they wish to hurt another person, the mental health professional is also required to notify the person who the patient wishes to hurt.

The duty to protect and the duty to warn are also important when it comes to HIV and AIDS. There are many ethical problems when it comes to diseases such as HIV and AIDS when it comes to confidentiality and duty to warn. The basic duty of the health professional is to keep the patient’s information confidential as exposure of this information to the public could harm the patient. However, it is important for those who have had contact with the patient to know that may have been exposed to the disease.

When a health professional works with someone, there are a few things they can do to help protect the public while allowing the patient to exercise his or her right to confidentiality. Many health professionals in these situations counsel the patient about their need to tell those who may have been exposed to the disease about his or her HIV/AIDS status.

By giving a patient with HIV or AIDS the proper advice and information, a healthcare provider can avoid breaking confidentiality while protecting the public at the same time. Many health care professionals also warn the patient of criminal implications of knowingly exposing others to the disease while not notifying the other person of his or her HIV/AIDS status.

Please welcome today;s guest blogger Daniel Theyagu  fromhttp://www.thinklaterally.com

There are four ways in which a contract can be discharged. They are by performance, agreement, repudiation and frustration. When a contract is deemed to be discharged by performance what it means is that the parties to the contract have fulfilled their legal obligation and there is no further need to continue the contract. For instance, Ben offered his expensive watch to Sam for $5000. Sam accepted the offer and Ben delivered the watch to Sam and in return Sam paid him the agreed amount of money. In this case the contract has been concluded as both parties have performed their contractual obligation. Unfortunately, life is not as simple as this as there are circumstances where the parties to the contract might have difficulty fulfilling their contractual obligations. In such situation there may be partial performance only and the question is whether this is acceptable.

Let’s say that Simon is a math tutor and he agrees with Mary to teach her math tuition for 10 lessons at $100 per lesson. Simon completes 6 lessons and is unable to continue teaching Mary as he has some personal problems that he needs to settle. The question is whether Mary has to pay for the 6 lessons that Simon already conducted. At one time, the court were of the view that if a party to a contract has not completely fulfilled his/her obligation there is no need to compensate them. However, over a period of time the court have reconsidered this and now there is a possibility that Simon might be able to claim for the 6 lessons on what is called a ‘quantum meruit’ basis. This is a Latin phrase which means ‘payment for work done’. But Simon’s ability to claim the partial payment is based on whether Mary has in anyway benefited from the contract. In this case Mary may have benefited from the contract and might have to pay. However, if Simon only conducted one lesson and gave up teaching her, perhaps Mary might refuse to pay as she can claim that she has not benefited from the contract. This is relatively subjective and something the court might have to decide based on the merits of the case, if ever such a case goes to court.

There are circumstances however where part performance need not be compensated. What if you were to order a chicken chop in a restaurant and it turned out to be half cooked. Can you pay half price for this? Obviously not!

Another way a contract is discharged is by agreement. This is when both parties agree before the contract is made that when a certain event occurs that the contract will be discharged or that if either party wants to terminate the contract they should give the other party a period of notice. Discharge by agreement is a common feature in employment contract where the parties might agree before hand that if the employee wants to resign, he/she must give a period of notice and vice versa for the employer as well. Another example is the pre-nuptial agreement that couples enter into before marriage.

The third way in which a contract is discharged is by Repudiation. This is where one party deliberately breach the agreement. For instance, Michael agreed to sell his piano to Susie for $3000. Susie agrees to buy the piano and tells Michael that she will pay him the money the following the day. Afterwards, Brad comes along and agrees to buy the piano from Michael for $5000. Michael sells the piano to Brad. By doing this he is in breach of his agreement with Susie as the contract has already been decided between Michael and Susie. Susie is within her right to sue Michael for the breach of contract. There is a possibility that the court might order Michael to buy the piano back from Brad and sell it to Susie at the price agreed or to give some form of compensation to Susie.

The last method of a contract being discharged in by frustration. This means that one or both parties cannot fulfill their contractual obligation owing to some unforeseen event that prevents them from continuing with the contractual relationship. You bought a ticket to watch a famous pop group concert. Before the concert the lead singer of the pop group members died of a drug overdose. Therefore the concert is cancelled as it would be impossible to continue the concert. Therefore the contract is deemed to be frustrated. So you can get a refund on the ticket that you bought. It is possible too for a contract to be discharged when the contract becomes illegal to perform. For instance if there is a product on sale and subsequently the government passes a legislation that ban the product then further sales of the product is considered as illegal.

Once the contract is discharged it brings the contract to an end.

Please welcome guest blogger Richard Van-Rooyen

GMP stands for Good Manufacturing Practice and is absolutely essential when it comes to pharmaceuticals. In an effort to ensure that all pharmaceutical companies reach the high level expected and demanded of them GMP guidelines are set and enforced by governments. Whilst different countries have slightly different rules they all follow similar basic principles. Here are a few of the basic guidelines.

Manufacturing process

Manufacturing processes must be transparent and clearly defined by the company producing the pharmaceuticals. This ensures that regulating bodies are aware of every extract, ingredient and chemical that goes into a product and take action if any of these pose a threat to patients. GMP guidelines also state that any change to the product or the way it is produced also must be made aware to regulating bodies so they can ensure that the change is still in line with the law.

Distribution

When a company distributes its product it must ensure that the distribution process will have no effect on the quality of the product and the product will arrive at its destination with the same level of quality it had when it left the factory. If the product is being transported overseas for example then it has to be in a secure container to ensure that no external conditions can have any adverse effects.

Records

Documents detailing the complete history of each batch of product are also required by GMP guidelines. This is so that if there is a mistake that leads to faulty product, the batch can be tracked down before it reaches patients and causes any harm. These records must be easily accessible and kept in a manner that can be viewed quickly and efficiently. If there is product that poses a health risk then it must be recalled and destroyed as fast as possible and records and documentation are a vital part of keeping tabs on distribution.

Complaints

All official complaints must be recorded and each case should be examined to determine the cause of the complaint. Appropriate action should then be taken to ensure that the area the complaint references is improved to ensure that the issue is fixed. Complaints should be addressed and examined as quickly as possible to reduce risk to patients and customers. If not properly kept in check then serious problems can arise for companies but more importantly the consumers.

These are but a few of the basic GMP guidelines that pharmaceutical companies must legally adhere to, more detail is available online and from companies who specialise in the industry.

Please welcome today’s guest blogger Rose Marie Jones from
Http://lawyerwhenneeded.com

How can a regular person get an attorney when they need one? Lawyers charge a lot! Their fees can range from $100 an hour to $200 an hour in a rural area and small town, to $400 an hour in larger cities; especially if you are hiring from a larger firm, where there are more resources available to you. The average national billing rate is $284 an hour.

Most of the time you don’t even think about it, because most of the time we are not in legal trouble. If we are involved in a criminal situation we can get a public defender, for better or worse. But there are many times that having an attorney available would make all the difference, and yet we can not afford it. What if the laundromat ruins a valuable garment and doesn’t refund the money? What if we become one of the millions of Americans who have become behind on their mortgage or credit cards and have the creditors breathing down their neck? What are our rights? What if we have to go out on disability and wonder if we can make any money at all without breaking the law? It would help if we just had someone to tell us what our rights are, if we could just call a lawyer without breaking ourselves financially. And what if we just need a lawyer to write a letter for us? It is amazing how correspondence from a lawyer can change the attitude of some difficult people and companies, and if we are left without access to legal services we are out of luck.

What if we do not have a will? 55% of Americans will die without a will. This includes 52% of white Americans compared to 68% of African-Americans and 74% percent of Hispanics. Every American should have a will, but it appears that the lower percentage of African-Americans and Hispanics that have a will is due to less access to legal services. Unfortunately when you die without a will you are leaving your family to deal with practical headaches that could have been prevented, and to actually end up losing thousands of dollars. There are actually two problems that occur when you die without a will: you cause your family even more emotional turmoil at time when they are already suffering and the courts will have to appoint an administrator to dispose of your possessions, in a way that might be very much against your wishes.

What about a traffic ticket, or even worse a DUI? One little infraction, even something that does not hurt anyone can cause havoc in your life with huge fines. Even parking tickets can be ridiculously expensive. A lawyer can help.

What if the IRS is breathing down your neck? If you get into tax problems and you are not wealthy you can be in hot, hot water. The rich have all kinds of resources, but you are in trouble if you do not have access to a lawyer in times like this.

Most of us realize that it would be nice to have a lawyer available when times are really hard or even if you are doing alright but just don’t want to plunk down hundreds of dollars just to ask a legal question. Many people have been dismayed to find that their lawyers will charge them hourly for what they think is just casual conversation.

Please welcome guest blogger Russell F Moran from http://www.justiceinamerica.com

It has become an article of faith, especially among liberals, that our newfound “rights” empower us as individuals. There was a time when a school principal, faced with a disciplinary problem, would simply make a decision. Decision-making in the public sphere has become almost an old joke. In place of individual power to make decisions, we now see layers and layers of regulations, fashioned by well-intentioned regulation writers. If something doesn’t work, make a rule. If that doesn’t work, write a few more rules.

No school administrator wants his school to be placed on a list of dangerous institutions. At Jamaica High School in Queens, New York, an assistant principal noticed that assistant deans were calling 911 in response to violent situations. One of the results was that the school was placed on a city list of dangerous schools. Problem? Make a rule. He sent out a one sentence instruction that said: “Deans are not permitted to call 911 for any reason.” The rule was as simple in its clarity (a good characteristic of any rule) as it was insane in its removal of sound discretion. Mariya Fatima, a ninth-grade student, suffered a stroke. Because of the memo, employees waited over 1 hour before calling for emergency medical aid, a delay that has made her paralysis worse. Rule-making strips power away from individuals who really need the power, the discretion to make on-the-spot decisions.

Anyone who has ever encountered a local building department has seen up-close how rules, as opposed to intelligent discretion, can result in a nightmare. I have a friend who runs a municipal golf course. He wanted to put a canvas cover over the tee-off spots on the driving range so that golfers could use the driving range in the rain. Great idea – more money for both him and the municipality. Not so fast. There was a building department rule that required that all new structures be able to withstand a wind of 120 MPH. He tried to explain that the “structure” was simply going to be a pipe frame with canvas on the top. If he forgot to roll up the canvas before a hurricane, so what? What damage could a piece of flying canvas do?

But no. A structure is a structure, and the new building code says it must be able to handle a hurricane. In a sane world, the building inspector could have made a decision that his proposal was not contemplated by the rule, or at most the inspector would have passed it by his supervisor for a written ruling. But the inspector was not in charge: the building code was. It is easy to argue, as bureaucrats do, that rules and regulations make for a just and predictable world. We are, after all, a nation of law, not men. But no set of regulations or laws can possibly cover every contingency, and to remove the ability of people to make flexible interpretations actually robs everyone of power.

Rules and regulations, even when intended to make things better, are depriving us of our freedom to make simple choices

The FDA is the principal watchdog for the pharmaceutical industry and one of the most heavily regulated areas is that of medical devices. Ensuring FDA compliance is of critical importance for pharmaceutical manufacturers for obvious reasons and in order to ensure this, most will turn to the expertise of pharmaceutical consultancy firms.

Any firm that manufactures medical devices will need to guarantee FDA compliance in order for their products to be deemed safe for the market. It is clear the reasons why being compliant is so important when it relates to medical devices because these products actually have to the potential to do harm if they are not sufficiently regulated. Compliance is a necessity for all within the pharmaceutical industry and many will employ consultants to help them achieve this in the remainder of 2010 and beyond.

What This Means For Medical Device Manufacturers

The actual term “medical devices” is extremely broad and encompasses a vast array of products – but the issue of FDA compliance is equally as important regardless of whether it’s high-tech diagnostic apparatus or a simple stethoscope that is being manufactured. The governance of the pharmaceutical sector is extremely stringent and it needs to be given the fact that faulty products or supplements have the potential to be harmful to the end user and this is something which simply cannot be condoned.

When it comes to FDA compliance, it stands to reason that medical devices are extremely carefully governed because of the nature of the products. Using pharmaceutical training and consultancy is a good idea for any manufacturer who wants to ensure that their product reaches the market in the shortest possible amount of time and isn’t at risk of the very expensive issue of product recalls.

Guaranteeing Compliance In A Fluid Field

The pharmaceutical industry is an ever evolving field and one that is exceptionally susceptible to change. This too applies to the manufacture of medical devices and the objective of ensuring FDA compliance is one that manufacturers simply cannot afford to ignore. Obviously, there will be a large number of legal implications when it comes to manufacturer the sorts of products utilised in medical fields and, in order to get to grips with these implications, most manufacturers look to pharmaceutical consultancy firms for guidance and assistance.

FDA compliance is something which is fairly straightforward to achieve so long as manufacturers listen to the guidance that they are provided with from specialists in the field. Most within the pharmaceutical industry wish to focus their attentions on providing the best possible product and will leave issues such as FDA compliance with the consultancy experts they have employed to keep their products on track.

The pharmaceutical industry in the United States is governed by a watchdog called the FDA and they are responsible for helping ensure the safety of the goods manufactured. FDA compliance guidelines need to be adhered to by manufacturers when they produce medical devices, pharmaceutical drugs or food.

FDA compliance is an issue of the utmost importance as it is something that helps keep the end user out of harm’s way when it comes to the manufacture of medical devices and other pharmaceutical goods. The FDA will regularly inspect pharmaceutical manufacturing plants to help satisfy themselves that good manufacturing practices are being followed and that good quality goods are being consistently produced.

Why Compliance is So Imperative in the US

Please welcome today’s guest blogger Caitlin Andrews

FDA compliance is something that manufacturers need to strive for and in order to help them achieve this, more and more are turning to the services of pharmaceutical consultancy firms to guide them through each step of the manufacturing process from a compliance perspective. The overriding objective of the FDA is to protect the health of the United State’s public and it strives to do this through their formulation of FDA compliance guidelines which it expects those working within the industry to adhere to in order to ensure the safety of the products that they produce.

The issues surrounding compliance for pharmaceutical manufacturers aren’t always clear cut and this is why many will choose to employ the services of pharmaceutical consultants who will have a much greater understanding of exactly what is required from manufacturers to ensure that they have FDA compliance and that they produce their products to a routinely safe standard.

The Pharmaceutical Industry As It Is Today

Such is the size of the pharmaceutical industry in the United States, with hundreds, if not thousands, of products reaching the marketplace each day, it is clear what a gargantuan task the FDA have when it comes to helping guarantee the safety of these products. FDA compliance guidelines are instigated with the intention of making it clear to manufacturers what it is that is required of them when developing and producing their goods and the FDA will occasionally carry out inspections of these facilities to ensure that compliance levels are being met. If your products are not compliant you could pose a risk to individuals using those products. The FDA have to carry out these tests so that they keep the US safe.

For more information on FDA Compliance, speak to NSF-DBA.

A major part of FDA compliance is the make-up and wording of the label on the pharmaceutical products. Organisations must adhere to the FDA’s guidelines if they want to lawfully distribute their product.

This can make their production particularly tricky for manufacturers, as their make-up plays a crucial role in the product’s marketing.

As a rule, four basic elements are required to meet FDA compliance standards on all consumer product labels. These are:

• A statement of identity
• Quantity of content
• Ingredients
• The name and physical address of the manufacturer, packer or distributor

Depending on whether the product is a food, supplement, cosmetic or drug, there will be a number of other required elements that must be on the label so it can be legally distributed.

The reason labelling is so stringently regulated is because if it does not contain certain information, or it misleads with the information it has on, then a person’s health may be put at risk when they consume the product. It also ensures that the manufacturer of the product can be held accountable for what they are putting onto the market.

Labelling regulations on pharmaceutical products are getting tighter and tighter. This is because modern technology allows more reliable and detailed information on the make-up of a product than ever before.

If you are planning on distributing a product that will need to comply with the FDA compliance regulations, then you should consider seeking further advice on label compliance from specialist pharmaceutical consultants.

Label claim petitions and notifications can be submitted electronically directly to the FDA. Companies are urged to review their labelling to ensure they are in compliance with FDA regulations.

The FDA also urges organisations to breed a culture in consumers that encourages them to read labels thoroughly before taking the contents. This is crucial not only in meeting with FDA compliance regulations, but if the person is to responsibly take care of themselves and their family.