A couple months ago, I has to write a paper for my Economics class.  I chose to write about the FDA.  I specifically wrote about the food and dietary supplements that the FDA regulates and I also felt that I would be able to write something here that my clients can actually benefit from.  Well, enjoy the research paper, I did get an A on the project and I would like to know what you think as well.  If you would like a work cited page, one will be provided upon request.  

The Food and Drug Administration:  FOOD

By: William Bowen

Class:  American Economic Problems, T/TH

Professor Keep

Date:  05/17/2011

The FDA’s responsibility in the food category entails all domestic and imported food except meat, poultry, and frozen, dried and liquid eggs, which the US Department of Agriculture oversees those areas of the food industry.  Under the Food and Nutrition sections, the FDA is in place to set regulations, make compliances and issue policies in order to monitor the entire food market.  Within this section of the paper I am going to analyze the Food and Nutrition structure within the FDA focusing on the strengths and weaknesses of the current Administration, as well as providing suggested areas of improvement, such as stricter regulations on bioengineered foods and dietary supplements.  When it comes to all the regulations, compliances and issued policies that are in place for the Food and Nutrition section, the FDA covers the registration of food facilities, imported foods, Shell Egg Producer Licensing, food labeling and nutrition, dietary supplements, produce and plant products, seafood, food ingredients and packaging, enforcement, and finally food defense and anti-terrorism.  All in all, the FDA protects national food supply and regulates the safety of food for the American people.

Before getting in too deep in the structure of the food and nutrition sections, it is important to understand what an economic importance the food market industry plays in the U.S. economy today.  The yearly statistics published by the FDA estimate that consumers spend approximately twenty-five cents of every dollar on products that are regulated by the FDA.  Furthermore, of that amount, approximately 75 percent is spent on foods.  The Center oversees and regulates $417 billion worth of domestic food, $49 billion worth of imported foods, and more than $60 billion worth of cosmetics sold throughout interstate commerce.  The FDA also published that there are more than 377,000 registered food facilities that manufacture, process, package, and hold food consumed by humans or animals in the United States and several thousand cosmetic firms, which includes approximately 154,000 domestic facilities and 223,000 foreign facilities. (CFSAN)  The economic importance of the American food industry is incredible.  It accounts for 20% of the U.S. Gross National Product, and according to the FDA, it employs an estimated 14 million individuals with jobs and an additional 4 million jobs in related industries.

Under the compliance and regulations of the various food areas, there are 25 programs that have been created, from documents and policies on imported food and dietary supplements to guidelines and polices on creating nutrition labels and categorizing safe from unsafe ingredients in foods.  CFSAN has the responsibility of overseeing the administration of all 25 compliance programs.  The FDA has published the “Food and Drug Administration Compliance Program Guidance Manual”, which covers all of the areas of food safety, how each particular program will operate, annual program enhancements, oversight instructions of each program, and enforcement of compliance.  CFSAN must use the Compliance Manual to carry out policies and regulations in place to ensure complete food safety across all levels of the market and industry. 

According to the FDA website, The Center for Food Safety and Applied Nutrition (CFSAN) was established to work in conjunction with the Agency’s field staff, and is responsible for promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.  The FDA’s Compliance Program Manual is the Bible for CFSAN and their administration practices.  I will be referencing various chapters of the Compliance Program Manual as I address strengths and weakness throughout the food area of the FDA. 

When focusing on the food labeling and nutrition area of the FDA, there are many regulations and policies that are set in place to ensure that the information on the food labels and nutrition facts are accurate and to ensure the consumer is completely informed of the foods, ingredients, or edible substance they decide to put in their bodies.  The Food, Drug and Cosmetic Act of 1938 outlines how the entire food section will be regulated and The Nutrition Labeling and Education Act of 1990 was designed to give consumers more scientifically valid information about foods they eat.  As part the Labeling and Education Act of 1990, the guidelines on how to test the food to find out if any ingredients in foods were related to any health problems were put into place.  This helps the FDA maintain strict regulations on processed foods, mass produced fruits or vegetables, and other means of the production of food.  The FDA also regulates the information and lingo used on the front of food packaging that describes the amount of vitamins or minerals found in a single serving.  For example, a food product that reads “High, Rich in, Excellent source of” means 20% or more of the Daily Value.  If a label reads “Good source, Contains, Provides” means 10% to 19% of the Daily Value.  And if the label reads “More, Enriched, Fortified, Added” means 10% or more of the Daily Value (Duyff

Along with scientific tests that are carried out under the Nutrition Labeling and Education Act of 1990, the FDA also completes health and diet surveys every 6 years to find out information from consumers how much information they know about general health and wellness, as well as understanding the relationships between certain foods that contain higher amounts of fat and the increased risk of coronary heart disease.  Through these surveys, the FDA is able to determine what guidelines they will set for food label content the industry producers will need to include on the specific label.  They also create guidelines that food manufacturers must follow for healthy food symbols on the front of any product packaging.  Exhibit 1 shows and excerpt from the “Fact Sheet: Key Findings from 2002 and 2008 U.S. Food and Drug Administration’s Health and Diet Survey”.

EXHIBIT 1:

More Americans know about the link between diet and heart disease.

• The percent of the U.S. population who know diet is related to heart disease increased from 83% in 2002 to 91% in 2008.
• Among them, fats were frequently mentioned as related to heart disease, 53% in 2002, and 62% in 2008
• The percent of the U.S. population who know that certain foods or drinks may help prevent heart disease or heart attacks remained the same in 2002 and 2008 at 81%. Fruits and vegetables were most frequently linked with reducing heart disease.
• However, of those who were aware of the link, fewer mentioned the link between vegetables and heart disease (49% in 2002 and 34% in 2008) and between fruits and heart disease (36% in 2002 and 32% in 2008).

Americans’ knowledge of relationship between the types of fat they eat and heart disease has risen dramatically:

• The percent of the U.S. population that correctly identify that trans fat in the diet may raise the risk of heart disease has almost doubled in only four years- from 32% in 2004 to 62% in 2008.
• The percent of the U.S. population that correctly identify that omega 3 fatty acids may lower the risk of heart disease increased from 31% in 2004 to 52% in 2008.
• The percent of the U.S. population that correctly identify that saturated fat may raise the risk of heart disease did not show much change from 74% in 2004 to 73% in 2008.

Americans’ use of the food label has increased:

• The percent of the U.S. population that report “often” reading a food label the first time they buy a product increased from 44% in 2002 to 54% in 2008.
• Of those that read food labels when purchasing a product for the first time in 2008, the food label was most often used to:
• See how high or low a food is in things like calories, salt, vitamins or fat (two-thirds of consumers).
• Get a general idea of the nutritional content of the food (over one-half).
• Reported use of calorie information on the food label is mixed with almost one-half (46%) of the U.S. population saying they often use the label to gain calorie information and about one-third (34%) rarely or never using calorie information.

Use of nutrient content claims on the front of food packages is mixed among Americans.

• Reported use of nutrient content claims such as “low fat,” “high fiber,” and “cholesterol-free” is also mixed
• 38% of the U.S. population using such claims often,
• 34% sometimes, and
• 27% rarely/never using these types of claims.
• Reported use of the claim “0 grams of trans fat” is also mixed.
• 31% of the U.S. population saying they often refer to this claim,
• 36% sometimes, and
• 32% rarely/never refer to this claim.

Americans express different degrees of trust about claims on food labels.

• 41% of Americans trust that all or most of the nutrient claims such as “low fat” or “high fiber” are accurate while 56% believe that some or none of them are accurate.
• 56% of those who have ever used the “0 grams of trans fat” claim believe that all or most of the trans-fat claims are accurate, while another 42% of them believe only some or none of the claims are accurate.

Almost two-thirds (64%) of Americans report seeing nutrition labeling on menus, napkins or place mats in restaurants and about one-half of them use the information often or sometimes.

From my reading and analyzing the food labeling and nutrition information sections, I found that many policies and regulations are set in place to ensure food safety and to ensure consumers are fully educated with nutrition information of their foods they eat.  On the other hand, after researching the obesity rates across the U.S., obesity across the U.S. has practically doubled since 1990 (Center for Disease Control and Prevention). Below is a comparison of the obesity increases from 1990-2009.

 

 

After this discovery of information, the FDA has taken the necessary measures to ensure appropriate food safety and the delivery of truthful information of food facts, but they need to have new policies in place to promote healthier eating patterns to reduce the rate of obesity and the multitude of health risks that are involved with this.  According to Professor Becker, the average life span for our current generation has dropped to age 57.  The average lifespan for the baby boomers is 79 years of age.  If the FDA does not tighten their policies and regulations of the manufacturing of certain foods, the U.S. as a whole will perish a lot sooner than we think.

According to the Office of Dietary Supplements, National Institute of Health, Congress in the Dietary Supplement Health and Education Act, which became law in 1994, a dietary supplement is a product (other than tobacco) that meets one of the following below standards:

• is intended to supplement the diet;
• contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
• is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
• is labeled on the front panel as being a dietary supplement.

The FDA regulates Dietary Supplements under a completely different set of regulations than conventional foods and prescription drugs.  Dietary Supplements are monitored and regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA).  The Act states that the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.  Generally, the manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.  The FDA also regulates post-marketing of dietary supplement information.  These responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature.  Along with marketing, the Federal Trade Commission work hand and hand with the FDA to regulate dietary supplement advertising. (FDA)

After analysis of all research, dietary supplements are definitely not being regulated enough.  There are several instances within the dietary supplement market where companies create supplements merely as an avenue to produce movement/revenue in the economy.  According to Karen Gauci R.D., your body only absorbs 10% of any vitamin or supplement you ingest.  That means if you take a 100 Mg vitamin tablet, you will only absorb 10 Mg.  Mrs. Gauci also stated that supplements just make your organs work extra hard to break down an unnecessary combination of ingredients you can get from just eating healthy foods. However, supplement companies do not provide clients with this information and instead market the supplements in a way that seem quite health beneficial and necessary.

The FDA also sets regulations that deal with biotechnology and manufacturing foods.  In the Federal Register of May 29, 1992, FDA published its "Statement of Policy: Foods Derived from New Plant Varieties". The 1992 policy clarified the agency's interpretation of the application of the Federal Food, Drug, and Cosmetic Act with respect to human foods and animal feeds derived from new plant varieties and provided guidance to the industry on scientific and regulatory issues relating to these foods. The 1992 policy applied to all foods derived from all new plant varieties, including varieties that are developed using recombinant deoxyribonucleic acid (rDNA) technology. This site refers to foods derived from plant varieties that are developed using rDNA technology as "bioengineered foods."

According to Biochemical Engineering students Matthew Kuure-Kinsey and Beth McCooey, they describe rDNA as being the general name for taking a piece of one DNA, and combining it with another strand of DNA. Thus, the name recombinant! Recombinant DNA is also sometimes referred to as "chimera." By combining two or more different strands of DNA, scientists are able to create a new strand of DNA.
The most common recombinant process involves combining the DNA of two different organisms.  Under the 1992 policy, any new rDNA plant manufacturer must complete a vigorous set of actions and testing as well as show nutritional value when applying for licensing to manufacture food products for the consumer market. 

There have been some articles and scientists that claim that hormones and food additives have increased the growth rate of children over the course of a decade.  After analysis of the biotechnology of food production and further investigation on this matter, I have determined that further research must be completed to make any suggestions or provide any feedback for improvement in this area of the FDA. 

The Food Umbrella of the FDA plays a vital role in the United States, from the importance to the economy, to the safety of our country’s food supply and striving to maintain the safety of the American people.  Throughout this paper, I have analyzed compliance and regulations, food labeling and nutrition information guidelines, policies and regulations directed toward dietary supplements, and bio-engineered foods.  Upon completion of my paper, I have determined that the FDA is working hard to keep the current system running to ensure public health and safety, but there is always room for improvement in any system of administration that is established at this level of magnitude.  Food labeling and nutrition information is well regulated, but dietary supplements are a wide open market that has potential to cause serious damage of American citizens.  The FDA will continue to try their best to monitor and regulate the complete spectrum of the food and nutrition areas.