“FDA and Dietary Supplements”
A.)The “traditional paradigm” is the beliefs of man in comparing food versus drugs. Food is the basic need of man, as accepted world wide, which contributes to the growth and progress of human’s body and also gives energy in everyday. It also acts as a defense mechanism against sickness and other illnesses. And because it is the basic need of man to survive, it is proven safe rather than drugs or medicine which only cures diseases, and basically prescribed by doctors. While supplements help the body to gain energy.
The new paradigm now aids a great help to health providers. It is now believed that food together with medicine could prevent diseases more quickly. Because the medicine taken by man can interact more quickly with food and the results could be seen in less than a time. Taking only drugs can be dangerous than combining it with food. It is more often seen that patients with diseases regains their strength faster if they eat the right food together with taking the right medicine. Although the new paradigm still says that food can aid in more diseases, it also says that not all food can help in maintaining a healthy diet. For example, fatty foods should be avoided by persons who have problems in heart, so fatty foods should be banned in their diet. Lots of exercise and a healthy diet with fruits and vegetables can help them prevent getting strokes and heart attacks. Quitting smoking is also one of the great help to improve their healthy lifestyle. But it’s still not right to depend on foods for the rest of our life, especially in treating deadly diseases.
B.) A “dietary supplement” is a pill taken in to complement the diet, in can also be called as vitamins to help increase the desire to eat healthy foods. It contains minerals and vitamins which help the body to prevent getting sickness. Dietary supplements are often mistaken as medicines because of the fact that they are taken in by mouth. But it is clear that supplements don’t treat diseases, they only give the body the feeling of strength and healthiness. General claims are as that of health, nutrient and structure. The FDA regulates the dietary supplement in other ways than that of drugs. Supplements are not required to be analyzed by FDA for its protection in spreading it to the market because it is assumed to be safe rather than drugs.
C.) “Health Claims”, are describe as the connection of any material to an illness or connection to health. Example of health claims are that of if the material has an effect on helping reduce the danger of an illness. This health claims are approved based on the entirety of existing evidences more of scientific basis, authoritative statements and court statements.
D.) “Authoritative Statements”, subjected by a systematic body of a U.S Government with authorized duty for public health defense or a study particularly in relevance to human health and nutrition. One issue is that of, the 120 days proceeding to use the claims, the producer or maker must present to FDA a copy of the authoritative statement due to which the claim was based and a balance illustration of the scientific literature.
E.) “Qualified Health Claims”, are claims not needing to be qualified because the content is already acceptable. While the approved health claims are those of claims that were approved for they have valued legal stand or evidences and also has existing evidence as of scientific basis. The strength of evidence for qualified claims versus approved health claims is that, although, there are scientific evidences, but they are not definite, which means it is either a fact or just information from someone. In short, the evidences are not that strong.
F.) “Nutritional support claims”, such as “rich” in, “high” in, etc. can be used if the food or drug contains that certain nutrient or vitamins that is already identified by FDA in its regulations. It cannot be used in food classification except the claim is made in conformity with authorizing FDA regulations. The roles of FDA in reviewing the claims are that of they approve whatever claims that will be passed on them depending on the content of the claim.
G.) “Disease” is a malfunction of an organ, part or composition of ones body, which is suffering an abnormality or status of health heading to malfunctioning of some parts. Sometimes, diseases are caused by viruses that enter the blood stream leading the human body to collapse. Claims relating to disease were somewhat symptoms of diseases like arthritis, but FDA do not believe the law approves such products that claimed to be as pain-reliever, for diseases should be prevented nor cured. Conditions associated with a natural state are those conditions that occur in a specific period of life or natural occurrences that is not considered as a disease. However, FDA put the following claims under their final rule. FDA views OTC drugs may however be suitable of claims in labeling a supplement though OTC drug review would be considered by FDA. Statements that are OK for supplements are those of statements that say supplements are rich in, high in and those that really contains minerals and nutrients that is needed by the body as stated in the label. Types which are not OK are those which states that it is high in and rich in but not stated in the label. Natural condition supplement claim are those claims which are natural conditions of the body that is treated while taking supplements, examples are wrinkles, nausea and other signs of skin aging, while drug/disease claim are those which fall under claims about drugs that treats diseases, examples are osteoporosis and heart diseases.
I.) The traditional medicine especially the Smooth Move products are somewhat a dietary supplement and at the same time, a bit of medicine, for some products intend to relief and cure sickness, particularly constipation, sickness in the urinary tract, prevents aging and stress, stimulates the body, giving it energy for the entire day, and most of the products are antioxidants and also for women having problems about their menstrual cycle. This products give all the necessary information as for the supplements as FDA recommends.
I.) Chamomile tea is a supplement which usually has a calming effect on the user. Maybe, it would be difficult to produce chamomile products for the best chamomile products came from Nile Delta, Egypt, but farmers had their time of growing chamomile herbs here in the country. Chamomile tea can be in demand to consumers because of its calming and soothing effect on the user. But most probably, few consumers who believe in the product will take chamomile tea as their calming agent. I would probably market it as a supplement and give taste test and samples of the product to target consumers, preferably, the old ones who really want chamomile tea for its soothing effect on their body.
J.) The major issues on the IFT report about “Limitations of Current Policies” were the function and health claims cannot be entailed as disease claims because the terms used to illustrate health claims should be cautiously phrased therefore the claims are true and not confusing.
The classification of the Sterol Ester case is somewhat confusing because FDA allowed those products to be marketed because of the claims that it provides nutritive value, has taste and has aroma which were not contributed by the product, only, it could exposed health care if it is found that this product would gives nutritive significance.
“Dietary Supplements Regulation”
A.) The Dietary Supplement Health and Education Act (DSHEA) law for supplement regulations in the U.S deals that supplements are food products that intend to provide the body vitamins and minerals and usually made from or contain herbs and other amino acids that contributes health to the body and the labeling of products as supplements depends on it’s mineral content while the Canadian System of Regulation with Natural Health Products Regulations (NHPR) are appropriate to sale, produce, package, label, import, distribute and storage of the products are administered by the newly created Natural Health Products Directorate (NHPD) within Canada.
B.) The Canadian System of Regulation makes more sense because it does not require any claims than that of the U.S Regulations. In Canada, the products were standardize as either food or drugs by the Food and Drugs Act and Regulation, and the drugs are required to have a pre-market approval and also the issuance of DIR or Drug Identification Number. And this regulation has a system that made it easier for the issuance of the product’s safety.
C.) Hill’s criteria are used to appraise research conclusion and this criteria have directed the assessment of diet and health interrelationship for at least twenty years. Other factors to consider in evaluating efficacy according to IFT committee are the relating of the precise benefits to the use of individual foods that needs exact scientific procedure.
D.) The evidences for the efficacy of the omega-3 fatty acids are strong for it is based on research studies that centers on the function of omega-3 fatty acids in varying gene appearance and also give a healthy advantage. But it is found that intake of omega-3 fatty acids had no connection in controlling or reducing the risk of coronary heart disease (CHD). FDA showed that omega-3 fatty acids have no outcome on serum cholesterol and therefore it also has no connection in the case of CHD.
E.) The report about the safety of a supplement and the suggestion of its evaluation should be done for when a component is classified as generally recognize as safe (GRAS), there should be dependable information about the substance properties and safety before and after its opening to the consumers.
F.) The Dietary Supplement and Nonprescription Drug Consumer Act helps in the assurance of the safety of the supplement further by requiring the manufacturer or producer of supplements to pass to the secretary a report obtained of a serious occasion connected to a dietary supplement while used in the U.S and also a copy of the label of a dietary supplement.
G.) The author’s words became important in classifying and regulating vitamin B14, pangamic acid because the FDA had apprehended criticism for Aangamik tablets produced by Food Science Laboratories. FDA claimed that the tablets were contaminated for it contains food additives and supposed was unsafe. And it was also classified as either a vitamin or a pro vitamin.
H.) Example that the author used to show the need of GMPs for dietary supplements is the issue in which two women had intake of this dietary supplement and founded that they undergo traditional symptoms of digitalis-induced cardiac toxicity because the said supplement was founded that it contain a plantain called Digitalis lanata which is found that it is an infected dietary ingredient.
I.) The positive impact of GMPs in companies and consumers, they could see the products if it is safe or not before presenting in the market and before using it by the consumers because it would be tested first before the products will be produced. The negative impact is that the products would be stocked for a long period of time because it should be tested first, the companies will wait for the results, it needs a lot of time and effort for the companies to stop the manufacturing of the products and the consumers will look for another product which are already tested and safe, so the companies that is producing the products would suffer from the decrease of their sales due to the waiting of results.