FDA Bans 7 Artificial Flavoring Substances

Many consumers are unaware that they are ingesting substances that are not good for them. These substances are usually written as “artificial flavors” on product labels.  Recently, the United States Food and Drug Administration released a list of seven artificial flavoring substances that are harmful to health. These flavorings include ethyl acrylate, benzophenone, eugenyl methyl ether (methyl eugenol), ethyl acrylate, mycrene, pyridine, and pulegone.

The Substances Were First Approved by the FDA

These synthetic substances might be foreign to ordinary consumers, but they were first approved by the FDA during the early 60s. These substances are used for a wide variety of purposes such as mimicking or enhancing natural flavors. They are used to impart the flavor of mint, cinnamon, and floral in ice cream, baked products, beer, candy, and chewing gum.

The flavoring industry and FDA mentions that there is no risk to the public when consuming these products as long as the quantity is small. But even if this is the case, there are a growing number of people who prefer not to eat or drink anything synthetic.

Natural Alternatives Needed for Artificial Flavoring

Many people are opting not to buy products that contain artificial flavoring or substances. As a result, food companies are looking for natural alternatives to flavor for food. Petitioning to ban these substances pose a significant risk to many food manufacturers. The Flavor and Extract Manufacturers Association noted that the delisting of these substances confirms that there is a need for FDA to assess the actual risk instead of still following the 60-year old provision of the Delaney Clause.

The Delaney Clause was the statutory provision created by the FDA. In a nutshell, the provision strictly discourages the FDA from approving any food additives that can induce cancer to humans at any dose. And since the substances mentioned above did not reveal to cause cancer in the past, their use was continued until today.

Approving the Petition May be Difficult

While these substances may not be linked to inducing cancer, they can cause other health problems that are as concerning as cancer. However, FDA noted that approving the petition to ban these substances may not be that easy as the agency receives more than 200 petitions annually and it takes several weeks or more to evaluate and validate each.  But because of the public outcry including those from the institutions such as the Center for Food Safety, Center for Science and Public Interest, and the Natural Resources Defense Council, the FDA was forced to act.

The Implications

The implication of banning these substances is to push the manufacturers will likely be looking for natural substitutes and determining how they can change recipes using natural flavoring. But this might take a while, and many food manufacturers are asking for at least two years to be able to have a smoother transition in getting the job done. But on the bright side, switching to natural flavoring can draw in more consumers leading to a competitive boost for a variety of products.

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FDA Approves 8 Ingredients for Fiber Claims

Food manufacturers today boost their products by adding fiber to make them healthier. Fiber is not only found in bread but even in ice cream, brownies, candies, and gummies. For instance, a small bag of Smart Sweet gummy bears contains 28 grams of fiber so that you can get a whole day’s fiber requirement from your favorite sweet.

Fortifying food with fiber is the recent hype among food manufacturers, and the US Food and Drug Administration is supporting the bandwagon by finally approving ingredients that can boost the fiber content of different products. This initiative stemmed after the 2016 rule that indicated that added fiber does not only add the non-digestible carb content on food, but it provides overall health benefits.

Approved Fiber Claims

Today there are eight (8) ingredients approved by the FDA, and these include alginate, arabinoxylan, inulin and inulin-type fructans, galactooligosaccharide, high amylose starch, resistant dextrin/maltodextrin, and polydextrose. While there are the only eight on the list,  the FDA mentioned that it is planning to add other dietary fibers as long as scientific evidence proves that they provide additional health benefits.

Many food manufacturers are ecstatic with the decision of the FDA since it gives their new products the green light. Companies like General Mills and Activa have developed products that include fiber in them. For instance, General Mill’s Fiber One line of products contains inulin and inulin-type fructans. Other brands that contain inulin fiber include Frutafit from Sensus America, Oliggo-Fiber from Cargill, and Orafti from Beneo.

Health Benefits of Fiber

Speaking of health benefits, consumption of fiber can help stabilize both blood sugar and cholesterol levels. It can also help lower the blood pressure and promote good bowel movements. The presence of fiber in the intestinal tract can increase the efficiency of the body for mineral absorption. But more importantly, fiber can also aid in weight loss as it increases the satiety level for a long time.

Consumption of at least 15 grams of fiber daily can help prevent the onset of Type 2 diabetes and colon cancer. But in reality, so many people don’t even come close to the recommended minimum daily amount of 28 grams.

The Dark Side

The effects of putting fiber into food have done most companies good regarding marketing their products. Many consumers believe that food containing fiber is healthier. But this also presents a problem. According to Bonnie Liebman, director of nutrition from the Center for Science in the Public Interest, this might confuse people regarding which foods are truly healthy. For instance, they might opt for a brownie with added fiber over peach because they choose for convenience over real nutrition.

Because of this, it is essential for food manufacturers to explain what type of fiber they are using on their products as well as the kinds of health benefits that consumers can get from them. That way, people will be able to compare the benefits to naturally fiber-rich foods like fruits, vegetables, and whole grains. They can also impose upon the consumers to not be too indulgent on their products and that natural fibers occurring in fruits and vegetables should be prioritized.

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Scott Gottlieb’s FDA Will Continue to Push Food Transparency Measures

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With the focus on deregulation by the Trump administration, many food industry experts worried that the newly appointed commissioner of the FDA, Scott Gottlieb, would roll back pending changes to nutrition labels and consumer information. However, at a recent conference, Gottlieb made it clear that the FDA is going to continue to push for food transparency with Nutrition Facts, labeling, and definitions playing a significant role in the agency’s new nutrition innovation strategy.

Improving the Health of Americans Through Food Transparency

At the National Food Policy Conference in Washington, D.C., Gottlieb let everyone know that the nutrition innovation strategy is meant to improve the health of all American regardless of socioeconomic status.

“Our challenge is to help create more healthful choices and foster inovation and competition, and also make these choices more afordable.” – Scott Gottlieb, FDA Commissioner

A study found that 20% of American deaths in 2015 could be attributed to poor dietary factors. Gottlieb made sure to emphasize the importance of research and facts on everything his agency does. He said that clear science-based information is the central pillar of the work we do at the FDA and is essential to helping drive better consumer choices.

Nutrition Facts Labeling Updates


Gottlieb indicated that the new Nutrition Facts labeling initiative is of the utmost importance, but he wants to make sure it is right. He wants to roll out the new label with a consumer educational campaign to help the average American better understand how many calories they should be consuming each day.

On top of the new label, he promised to handle the definition of “healthy” and “natural” for labeling. A core definition of “healthy” is critical to help consumers better understand what they are buying. The new definition will consider nutrient content. Consumers also want more clarity on “natural” which has never been defined by the NDA. While Gottlieb did not offer up much on this definition, he did indicate that it will need to be science-based.

Streamlining the Labeling Process for Food Manufacturers

Gottlieb believes the regulatory labeling process is currently too lengthy and time consuming for food manufacturers. He has added to his docked to streamline the labeling process to modern times. He wants it to be easy for consumers to understand the health benefits of a product.

He wants to make it easier for the food companies to clean up their labels. Interestingly, he used vitamins as an example since they typically appear by their chemical name on the ingredient statement. We believe it should stay this way as most of these vitamins do not come from whole food sources and are chemically derived. Our GrandFusion products concentrate these natural vitamins from fruits and vegetables and as a result, allow products to use a much cleaner ingredient statement.

Conclusion on Gottlieb’s Remarks

The FDA is overall in good hands with this Trump appointee. He is committed to pushing forward all of the Obama-era regulations and making decisions on scientific fact. He believes some of the processes in the FDA are archaic and need updating to work faster in today’s environment. It will be interesting to see all the changes that move forward under Scott Gottlieb’s leadership.

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The Evolution of Nutrition Facts Labeling

According to the U.S. Food and Drug Administration, the nutrition facts panel is one of the most widely recognized graphics in the world. Food Dive recently published an article on the origins and evolution of nutrition facts labeling. Our post hopes to detail some of the key points from their report.

The History of the Nutrition Facts Label

FDA Historian, Suzanne Junod, told Food Dive that the nutrition panel has been appearing on food packages since 1994, but mandatory labeling dates back more than 100 years. Junod says,”The modern U.S. food-package label has evolved steadily throughout the 20th century, and its content and format are regularly revised to reflect and apply new knowledge in the fields of medical, nutritional and regulatory science.”

However, minimal changes have taken place within the past 20 years except for the addition of Trans Fat in 2006. If you looked back 100+ years ago, the Pure Food and Drug Act of 1906 established the FDA and was the first significant consumer protection law passed in the 20th century. The law intended to stop adultered and mislabeled products to improve consumer trust in the food and drug industries. Packaged foods started to grow at the turn of the 20th century as these goods were more convenient that bulk or boxed products.


From there, low-cost competitors jumped in to sell short-weight packaging meaning they put less food in packages and sold them for less. In 1913, Congress passed the first mandatory food labeling law with the Gould Net Weight Amendment. The amendment required all packaged foods to have the quantity of their contents marked on the package regarding weight, measure or numerical count.

The next significant change took place in 1938 in the Food, Drug, and Cosmetic Act which required all artificial flavoring, coloring, or chemical preservatives to be listed on the product label.

“We didn’t know that much about vitamins until the ’20s. A lot of them weren’t even discovered until then. And no one was really clear about the role they played in human nutrition,” Junod said. “But scientific studies began. That was pretty much when [the FDA] started getting into the nutrition business and taking a really hard scientific look at nutrients and what role they play in the diet.”
Suzanne Junod
FDA Historian

In 1940, the FDA accepted a standard for enriched flour that established the levels for enrichment with vitamins and minerals. The formula was adopted for white bread and later standardized for other food products. Nutrition facts labels would not change for decades.

Nutrition Labeling Activity From the 1970s to the 1990s

In 1973, the FDA published the first regulations that required nutrition labeling for foods. The foods included those with added nutrients for which a claim was made on the package or in advertising.

“Then in 1977, a Senate committee came out with a report called Dietary Goals for the United States. That was a landmark report. [It] said that Americans should be cutting down dramatically on sugar, salt, and saturated fat, and eating more fruits and vegetables, whole grains, beans, and healthful foods”
Michael Jacobson
Sr. Scientist at CSPI

The Department of Agriculture, would soon after published the first Dietary Guidelines for American which agreed with Senate findings: eat more fruits and veggies, eat less salt and sugar.

Mandatory nutrition labeling and the first nutrition facts label were introduced in the Nutrition Labeling and Education Act of 1990. The FDA spent a lot of time developing the nutrition facts label with an outside branding firm to be flexible for scientific advances in nutrition.

Where the Nutrition Facts Label is Going…

The new nutrition facts label is undergoing its first significant overhaul in almost 20 years. In the new version, the FDA requires added sugars, essential nutrients like vitamin D, potassium, calcium, and iron. The label was initially set to be active in 2018 but has now been pushed back to 2020. Many believe they are trying to line this up with the Department of Agriculture’s Non-GMO labeling law. It will be interesting to see how this all plays out over the next few years.

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Misleading Labeling Claims Can Land Food Companies in a Lawsuit

In today’s modern society, most consumers are driven to purchase healthy foods. Customers take the time to read and compare food labels to decide which products are right for them. Food producers use labels as a marketing ploy. Food manufacturers love to claim different kinds of health benefits to boost their products’ sales. Unfortunately, many of these claims are misleading.

The Problem with Misleading Food Labels

Food and beverage brands come up with the latest buzzwords that are designed to boost product sales. Consumers expect the labels to be truthful so that they can make healthier choices. Moreover, they assume that the government is keeping a strict eye on the food manufacturers.

While there is some truth to this, what’s good to know though is the system is currently working to make companies accountable for their misleading food labeling.  On August 12, 2016, the company Nature’s Way falsely labeled its coconut oil as healthy; thus, a California federal judge found that the firm’s advertising and labeling are misleading.

The company branded their products as a healthy alternative to shortening, margarine, butter and other cooking oils despite the fact that it is not much better than those products. Moreover, the company’s advertising and product labeling violated several state food regulations in Canada.

Food Labeling Laws

Food manufacturers are expected to evaluate their foods and make their nutrition labels.  They are allowed to make a margin of error of plus or minus 10%. The Food and Drug Administration imposes that all food producers are straightforward when it comes to labeling their food products. For instance, products that are labeled as “natural” may contain surprisingly unnatural ingredients. Moreover, food manufacturers should also include the exact serving size and calories on the label as part of FDA regulations.

FDA food label nutrition facts panel update for 2017 2018 2019 food companiesFDA Issues Public Warning

With the increasing trend of using misleading labels, the FDA strictly defines the term “natural” in food products, and it restricts many food manufacturers to abuse such claim. Those who do not comply with the agency often suffer repercussions.

For instance, the agency issued a public warning letter in 2014 to Premier Organics about its product named Arisana Coconut Butter Whole Coconut Flesh is not healthy because it contains high amounts of saturated fat per serving.

Another company that has found itself in hot water with the FDA was General Mills. The company experienced a lawsuit when it allegedly claimed that the product Cheerios Protein is a protein-rich version of the regular Cheerios when, in fact, it does not contain significant amounts of added protein.

The false advertising of many companies has led to the proposal of the Food Labeling Modernization Act to streamline food labeling and create a standard labeling requirement for all food products. With this proposal, food manufacturers will be more careful in using buzzwords like “natural” and “healthy.”


The Medical Food Trend is Growing

Hippocrates once said, “Let food be thy medicine and medicine be thy food.” Despite the advancements in medical technology, many people are now considering medical food and nutrition to treat diseases and improve health conditions.

In a survey conducted by Nielsen, 39% of American households have someone who suffers from a particular ailment. And with the aging population increasing, chronic diseases will only grow in the coming years. Traditionally, people have turned to medications to solve these problems.

According to the Nielsen’s Global Health and Ingredient Sentiment Survey, 70% of consumers worldwide and 60% of the American respondents noted that they are actively making choices for their health to avoid different conditions like diabetes, high blood pressure, obesity, and high cholesterol.

What is Medical Food?

Medical food is a new concept, but it is defined as food formulated for the dietary management of diseases with distinct nutritional needs that a traditional diet cannot fulfill. Medical food should be nutritionally complete and are designed to meet the distinct nutritional requirements of particular patients.

Companies like Hormel and Nestlé are now looking into medical foods to help their consumers manage their ailments through nutrition. Manufacturers want to join the niche of medical food because of the rising trend. Food brands who are delving into medical food are looking into producing foods intended for patients suffering from obesity, lactose intolerance, diabetes, Crohn’s disease, and gluten intolerance. Food companies understand that being health-conscious is one thing but using medical food is a safer way to treat chronic illness.

The Future of Medical Food

The concept of medical foods is still in its infancy stage, but many question its future. With many people suffering from chronic diseases, consumers are looking for ways on how to manage their conditions without relying too much on conventional medicine and treatments.

Medical foods will go through a lot of scrutiny than conventionally processed foods. The extra attention that medical food gets will not only be focused on its nutrition claims, but also its safety as well as marketing. Marketing is critical because brands should not sell medical foods that fail to meet its promises.

The U.S. Food and Drug Administration is responsible for regulating medical foods under the Food Drug and Cosmetic Act Regulations 21 CFR 101.9(j) (8). The regulations for medical foods is not yet that strict, so food companies are not required to get approval by the FDA nor undergo premarket review. Moreover, they are exempted from getting labeling requirements for its health claims. Although the regulations for medical foods are not that stringent, they will surely change as the market expands. Medical food has a bright future but will face challenges from the FDA and consumers as the industry niche grows.

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FDA Says No More “Unsafe” Trans Fats

In a bid to reduce heart attacks and heart disease among Americans, the U.S. Food safety regulators have decided to ban a primary source of artificial trans fats in processed foods. According to the Food and Drug Administration (FDA), partially hydrogenated oils (PHOs) are not “generally recognized as safe” for human consumption. PHOs are an important source of artificial trans fat in the diet of many Americans.

The regulators have given food manufacturers until June 18, 2018 (3 years) to remove PHOs from food products. The food safety regulators feel this is enough time for food manufacturers to ask the FDA for permission to use foods that contain PHOs or to reformulate their products to eliminate PHOs. The regulators say that at the end of the compliance period, no food manufacturer will be allowed to add PHOs to human food unless they have been permitted by the FDA to do so.

FDA’s Ostroff Sees Link Between Trans Fats and Heart Health

Dr. Stephen Ostroff, FDA’s Acting Commissioner, says this action is expected to prevent thousands of fatal heart attacks every year and reduce coronary heart disease. The FDA anticipates that many companies will achieve compliance with the deadline since some companies are already removing PHOs from their processed foods. Following consultations with experts and a review of the scientific evidence, a preliminary determination to regard PHOs as unsafe for human consumption was announced by FDA in 2013. Currently, regulators are in the final stages of the resolution after taking into consideration the comments from the public.

According to Dr. Susan Mayne, the Director of the FDA’s Food Safety and Applied Nutrition Center, the determination is based on the input from all stakeholders received during the public comment period, as well as extensive research into the effects of PHOs. Food companies use artificial trans fats to increase the stability of processed foods, extend their shelf life, and improve their texture. This is because they are more readily available and cheaper than natural versions from dairy and meat sources. Since 2006, companies have had to show trans fat content on the nutrition facts labels of food products sold in the US.

The primary sources of PHOs in the American diet are savory snacks such as coffee creamers, microwave popcorn, ready-to-use frosting, and frozen pizza. Other sources include cakes, pies, cookies, fried foods, kinds of margarine, and spreads. PHOs are bad for health because consuming them increases “bad” cholesterol ( LDL) and lowers “good” cholesterol (HDL) in the body, raising the risk of coronary heart disease.

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117 Nutritional Supplements Companies Charged in Federal Sweep

Nutritional supplements companies that have been accused of selling tainted products and providing misleading information are facing the wrath of the justice department and the market. The federal Justice Department has filed cases against 117 companies and individuals. With some of the companies facing criminal and civil cases, the big retailers in the dietary supplement market saw their shares have dip initially before the full details were released to the public. 

USPlabs Faces Charges on Multiple Supplements Brands

One of the notable companies indicted in the suit is USPlabs, the Dallas-based company which sold Jack3d and OxyElite pro, two of the best-selling workout supplements containing an amphetamine stimulant. Six executives from the enterprise face prosecutions for selling the products that the justice department claims to be illegal and dangerous. The two largest retailers of USPlabs supplements, GNC Holdings and Vitamin Shoppe have suffered; the crackdown has led to both of their stock prices dipping. GNC Holdings shares went down by a whopping 27 % while Vitamin Shoppe lost nearly 10% before the market realized that the retailers were not named in the suit by the justice department.

USPlabs is being accused by the FDA of passing misleading information to the retailers and wholesalers; the company claims that its products are made from natural plant extracts whereas investigations revealed that they have been using a synthetic stimulant that is made in a Chinese chemical factory. According to the proceedings brought against the company, one of the products sold by USPlabs has led to liver injuries and one death. According to the marketers, the products enhance performance through increasing endurance, speed and strength. 

Another product that is sold by USPlabs, Jack3d was banned in December 2011 by the department of deference when two of the soldiers died after consumption. Some shops operated by GNC Holdings were also affected when the DOD banned the product on military bases and surrounding areas.

Increased Regulation Causes Anxiety in the Market

The news that the Justice Department was making an announcement on the charges caused panic in the stock market, the investors were anxious, when the decision was made, companies that were not mentioned in the list got a reprieve. GNC Holdings and Vitamin Shoppe were not mentioned in the cases that were brought by the federal prosecutors leading to a slight recovery in share prices. The crackdown is a positive move to ensure that the consumers are well protected from harmful products; the investors can also learn from the incidence, use of ingredients that harm the consumers will not only lead to numerous criminal and civil cases but will also adversely affect their businesses.

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