The FDA and Pharmaceutical Product Development

To help safeguard American consumers, the Food and Drug Administration or FDA plays a significant role in pharmaceutical product development. The FDA, through its Center for Drug Evaluation and Research, conducts extensive testing to ensure that these drugs are both safe for human use and effective for the diseases or conditions they are intended to treat.

Initially, potential new drugs are tested in laboratories. Once enough pre-clinical data has been acquired for companies to consider moving on to patient trials, the company submits an Investigational New Drug (IND) filing to the FDA. After an IND is approved, several phases of clinical human trials are conducted, during which the FDA tests for both safety and effectiveness.

The first phase of clinical human trials assesses the safety of a new drug in healthy volunteers, as well as its pharmacokinetics, or how the human body absorbs and distributes the drug to the system. The second phase of human clinical trials is concerned with the effectiveness of the drug, and can involve hundreds of volunteer patients. Once a drug has passed the first two phases, it undergoes a much larger scale of testing, which can last up to several years.

Once the FDA is satisfied that the drug is beneficial and that the manufacturer is able to produce the product at high levels of quality, the drug can be approved for sale in the USA. However even after it has been approved, the pharmaceutical product development process can still continue. The FDA may require another phase of post-approval surveillance in order to watch for side effects that may not appear initially.

Reading Food Labels to Control Calories and Other Nutrition Choices

Control Calories and Make the Best Nutrition Choices

Many people get confused as they are reading food labels. There are many tricky terms that can confuse someone who is trying to control calories, carbohydrates, protein, fiber or fat intake. If you are one of these people, don’t worry. These facts will help you make better nutrition choices.

Understanding Food Terms

Here are the meanings of everyday terms used by food manufacturers. It is important to know what they mean so that you can choose your foods wisely.

FDA – FDA is an abbreviation for the Food and Drug Administration. As part of the United States Department of Health and Human Services the Food and Drug Administration is responsible for food safety regulations. They also regulate drugs, vaccines and medical products. Usually, food labels are regulated through the FDA.

Low Calorie – The FDA defines low calorie as a food that is more than two tablespoons and does not provide more than 40 calories. Check those labels, though! Many low calorie foods are high in fat by percentage.

Reduced Calorie and Light – The FDA considers a food reduced calorie or light if the calories have been reduced by one-third over the original. Once again, these products can be high in fat.

Calorie Free – The FDA says that a product can be labeled calorie free as long as it has less than five calories per serving. If you don’t consume a lot of these products it’s a way to control calories.

Low Fat – The FDA considers a food low fat if it has three grams or less of fat. Watch out, though, these foods can be very high in calories and sugar.

Fat Free – Think fat free means fat free? Think again. The FDA says that if there are fewer than 0.5 grams of total fat per serving a product can be called fat free. So, that fat free product may still contain fat.

Reduced Fat – Reduced fat is regulated as a product that contains 50 percent or less fat of the original food version. It may sound good, but make sure to check the label. Even 50% less can still be more fat than you are willing to ingest.

Fiber – For a healthy diet a person needs about 25 grams of fiber per day. If you haven’t been getting that much be sure to increase your daily intake gradually so your body gets used to it otherwise you may suffer from bloating and gas.

Sodium – I hate food with lots of sodium. Why? It tastes bad to me, it’s probably over processed, it makes me thirsty then when I weigh myself the next day I’ve gained about two pounds of water weight; totally de-motivating. The only time a high sodium snack makes any sense is if I am doing a very long and strenuous workout and I need to keep the electrolytes in balance. Gatorade works as well.

How to Choose

Maybe you just want to eat something really tasty like some chocolate Milano’s. In this case disregard all the label info and just go for the tastiest treat you can find but don’t do this on a regular basis. Maybe limit this behavior to once per month or less.

Look at your goals for eating. Fat and calories are not the only things to consider. You need protein and fiber in your diet too. Also, check the quality of the fat in the product. Unsaturated is better than saturated. And remember that your diet should contain about 25% of the calories from fat. If you don’t eat enough fat you will feel hungry and want to eat more.

Carbohydrates come in different forms too. Some are pure sugar or sugar derivatives such as high fructose corn syrup which I tend to avoid. Choose more complex carbohydrates if possible.

When comparing foods I usually pick the ones with highest fiber, high protein, low sodium and good quality fats and carbohydrates in that order. This usually results in a balanced food choice. If I just need a blast of energy in the middle of a long bike ride, then a high sucrose product or a diluted sports drink works fine.

One comment about serving size, the information printed on the label almost always refers to a single serving size. When I look at the package of nuts I think, gee, only 100 calories, nearly all from fat. However, there are eight servings in the bag. What are the chances I’m only going to eat one serving? Probably zero percent. So that means I’ll probably eat at least half the bag, 400 calories from fat. Get it. Think about how much of the food you are going to eat at one time then decide.

What to Do with the Facts

As you can see, just because a food has a snappy food label on it doesn’t mean that it is 100% great for your diet. Always, always check the Nutrition Facts label with an eye towards finding out the true amount of calories, carbohydrates, protein, fat, fiber and the serving size. Think about what you want out of the food you choose. You have a lot of nutritional choices within product types. Reading food labels to control calories is one way to look at it but there is much more information provided to help you make the best food choice for your current needs.

Your Diet And Sexual Performance

On the one hand it is said that men think about sex every few seconds. On the other hand there is a multi-billion dollar industry in pharmaceuticals for treatment of erectile and sexual dysfunction. Obviously there is a significant disconnect between the desire to perform compared with the ability to perform effectively.

The human sexual response is incredibly complex and is influenced by many elements including psychological, physical and environmental factors. Aphrodisiacs have been promoted to increase libido and sexual performance for over 5000 years. The term Aphrodisiac is named after the Greek Goddess of love and beauty Aphrodite and has over time included many and varied foods, drugs, drinks, scents and devices.

Chilies and Spicy Foods have been thought to be an aphrodisiac since it produced sweating and increased heart rate similar to that experienced during sex. Other items such as Ginseng (which translates to “Man root”), Oysters and Rhinoceros horn have earned a reputation as Aphrodisiacs primarily due to their physical resemblance to the external genitalia. However, given the complexity of the sexual response it is unlikely that any one element will work in all circumstances or work at all. The multitude of spurious claims made by promoters of so called aphrodisiacs prompted the Food and Drug Administration (FDA) to issue a declaration in 1989 that there was no scientific evidence that any of the over the counter aphrodisiacs work to cure sexual dysfunction.

While there may be no magic potion that will cure all forms of sexual dysfunction there are many commonsense dietary rules that could impact positively on libido and sexual performance.

It is an almost a self-evident fact that a diet that promotes general health and well being will also promote sexual health and sexual performance. Anyone who has suffered a simple ailment such as the common cold will testify that libido and sexual desire are the first casualties of a lack of general well being. It’s extremely hard to feel “sexy” or sexually aroused when other bodily functions are not at par. Blood flow to sexual organs is an integral part of the arousal process in both males and females. As a result a diet that promotes heart and circulatory health will almost inevitably improve sexual performance.

Obesity is another killer of libido and sexual performance. It impacts in many ways. Firstly, obesity is often associated with plaque build up in arteries that affect circulation of blood through the body including the genitalia. This not only decreases sexual performance but may also reduce sexual pleasure. Secondly obesity is also a risk factor for erectile dysfunction and low testosterone levels. Studies at the University of Columbia Medical School have shown that weight reduction can lead to increased levels of testosterone and consequently improved sexual performance. On the other hand too little fat in the diet may not be a good thing either. Some fat is required for the production of hormones. Hence it is important to strike a sensible balance.
There are also certain other specific foods that are credited with an improved sex life while others are to be discouraged.

Alcohol in moderation may lower inhibitions and help to set the mood. However, when consumed to excess although it may heighten desire it definitely impairs sexual performance.

Chocolate contains a compound called phenylethylamine that triggers the release of dopamine a chemical that is also released during orgasm. As a result chocolate can promote feelings of euphoria and enhance pleasure.

Chilies can stimulate the nervous system, which in turn may accentuate the sense of sexual arousal. This may be achieved through the release of endorphins in the brain.

Ginger is believed to have a similar stimulant effect that improves circulation to the genitals.

Honey is rich in the mineral Boron that helps the body utilize the hormone estrogen.

Oysters may be good for you after all. Their magic powers however have nothing to do with their appearance. Instead it is their zinc content, which is valuable. Zinc is essential for production of testosterone and zinc deficiency may cause prostate problems in men. Healthy zinc levels are also vital to maintain sperm counts.

Soy is credited with benefits in combating the effects of PMS and Menopause in women and may help improve vaginal lubrication by better utilizing estrogen. Soy is also believed to promote prostate health.

There may not be any magic potion to create a raging libido and sexual desire and performance may be affected by many factors besides what we eat. However, the evidence seems clear Maintaining a generally healthy diet and supplementing it with certain foods in moderation can have a positive impact on sex life.

It’s Difficult to Live Healthy in America

The biggest reason it’s difficult to live healthy in American is because our government does not properly regulate safety measures in anything we eat, drink, swallow or breathe.

Oh! You say, “wait a minute” what about all these agencies that control all these safety measures? Well that’s the number one problem, they are government agencies and they are so corrupt that it’s unbelievable.

The FDA (Food and Drug Administration) is probably the most corrupt of all the agencies. They are “supposed to” regulate safety in our food and our drug products. Ha! Ha! That’s a joke.

But you know what? It really isn’t funny. It’s disgusting and very disturbing that we can’t trust our own government to do the job of protecting us. Let’s start with food regulation. Fast food (namely called junk food) is one of the worst culprits when it comes to your food intake.

Commercials tell our children that junk food is good food. And that industry spends 10 billion a year marketing to children. Food is not considered “junk food” just because of high fat or sugar content. There is a long list of poisonous chemicals used by the food industry that are harmful to everyone.

There are many serious nutritional deficiencies in today’s food that diminish the body’s capacity to deal safety with these chemicals and heavy metals, especially with magnesium and selenium being at the top of the list.

Now while we are on the subject of fast food let’s talk about soft drinks too, which is usually part of the regular diet at fast food restaurants. Especially dangerous are the diet drinks that most people believe are healthier than regular soft drinks.

In most cases the sweetener is these drinks is aspartame. Dr. Adrian Gross told Congress that without a shadow of a doubt, aspartame can cause brain tumors and brain cancer and violates the Dalaney Amendment, which forbids putting anything in food that is known to cause cancer.

What’s really interesting here is Dr. Gross is FDA’s own Toxicologist. So here we have two very concerning situations. The FDA doesn’t ban the product and the government officials let it slide by.

Besides the soft drink issue we are also faced with our personal drinking water issue too, which would take up at least a whole article on this subject alone.

The biggest issue that really tops all others is the pharmaceutical industry. At the present time it’s reported that 50% of the U.S. population is taking some kind of prescription drug.

Here’s an interesting observation of a typical visit to your doctor. First of all you probably spend more time in the waiting room waiting to get in to see your doctor than the doctor spends discussing your ailment. When you do get in there to see them, I’m betting he or she never gets to the core reason for your illness.

In the case of my doctor, who I only visit a maximum of two visits a year, it’s to talk to him about weaning me off of my high blood pressure medicine. By suggesting certain nutritional supplements he believes that will eventually happen fairly soon.

This is the kind of doctor everyone needs. But from all the information I’ve gathered from various sources, this is not the function of your typical doctor. Since they get very little education about nutrition in all their hours of medical school, they wouldn’t know what supplements to suggest.

The whole point I’m trying to get across to everyone is if you got a medical problem, it needs to be addressed immediately. However you don’t solve your illness by taking prescription drugs, that’s only a band aid solution. You need to find out WHY
You got your health problem.

If you got a pain, find out WHY you got a pain. If you find it hard to get through the day because your energy gets depleted easily, find out WHY you are not energetic. If you can’t sleep at night, find out WHY you can’t sleep.

Some people believe they can solve their own problem by buying pills off the shelf and taking them whenever they think they need them. That could be the most dangerous decision you could ever make.

Tylenol’s commercial ends up saying, “feel better.” Well you know what? You probably will feel better a little while after you take the pill. But once it wears off you take another one and another one and… Before long you are hooked for who knows how long.

This kind of situation could be endless until someday when it could just “back-fire.” Sooner or later, I guarantee, it will “back-fire” with some other kind of illness that you experience later. So now, all of a sudden, the “feel better” turns into “feel lousy”

But wait a minute, its really not “difficult to live healthy in America” – That is IF. And that’s a big “IF” That is IF you take charge of your own health and start getting the right answers about how to get healthy and stay healthy.

Here’s the best advice you will ever get on a health issue. First find a doctor who “cares about you” and starts to treat your illness with alternative methods instead of conventional methods. Secondly get off any prescription drugs you are on with his withdrawal methods.

Then live the healthiest life you have ever lived for as long as you want.

The information provided in this guide and on this site is neither intended, nor should
it be taken, as medical advice. It is provided solely for entertainment purposes.

Disclaimer

The information provided in this guide and on this site is neither intended, nor should it be taken, as medical advice. It is provided solely for entertainment purposes.

The authors and publishers are not doctors. You should always consult your doctor for professional medical advice.

Sonny grew up in a family that owned a local florist business that lasted for 63 years. For 29 years he was personally involved in the business. Eventually becoming dissatisfied with it he left to become a sales representative and spent more than 20 years in sales roles.