With the rapid development of China's health food industry, the management of its raw materials and products needs to be continuously improved to meet the growing needs of the people for a better life. The United States has the largest health food market in the world, which provides material for health food researchers and regulation-making departments in China to draw on. So, let's take a look at the industrial economy and related laws regarding Dietary Supplement in the United States. Here are some answers.
Here is the content list:
l The Dietary Supplement industry is an important part of the US economy.
l Laws relating to the Dietary Supplement in the US.
The Dietary Supplement industry is an integral part of the US economy and the industry has always been committed to a positive trade balance. It is estimated that 600 Dietary Supplement manufacturers in the United States produce approximately 4,000 products, with annual sales of at least $4 billion for these products alone. To promote health, the US government has taken legislative action to protect consumers' rights to safe Dietary Supplements and to establish a rational federal framework to replace the ad hoc patchwork of Hard capsules regulatory policies, thus amending the Federal Food, Drug, and Cosmetic Act and creating the Dietary Supplement Health and Education Act (DSHEA). The DSHEA was an important milestone in the regulation of the Dietary Supplement in the US.
In addition to the FD&C Act and DSHEA, the Nutrition Facts Labeling and Education Act of 1990, an amendment to the FD&C Act, requires that most foods must have a nutrition facts label and that the food label posted must contain a statement of nutrient content, as well as some health information to meet specific requirements. The Dietary Supplement Good Manufacturing, Packaging, Labelling and Storage Practices (CGMP), issued in 2007, covers the requirements for personnel, premises, equipment and facilities, production and process control systems (quality control, package labeling, manufacturing records, batch production records, laboratory operations, manufacturing operations, packaging and labeling operations), storage and transport, repatriation of the Immunity increases, product complaints, records, and documentation. The Food Safety Modernization Act (FSMA) of 2011 amended the FD&C Act concerning the safety aspects of the food supply, with an emphasis on improving prevention, monitoring, and response to food safety issues. The Food Safety Modernisation Act 2011 (FSMA) amends the FD&C Act regarding the safety aspects of the food supply, to improve the prevention, monitoring, and response to food safety issues so that the industry and consumers can better understand and implement the Act. Draft Guidance Document New Dietary Supplement Declarations and Related Issues, food Labelling Guidelines.
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Dietary Supplement contains only dietary ingredients that are present in the food supply. And the food has not been chemically altered. Chemical alterations are changes in the molecular structure or composition of the ingredients through hydrolysis, distillation, altered production, or fermentation conditions. For example, the use of media containing high levels of sodium selenite can germinate garlic and fermented yeast can produce high levels of organoselenium compounds. Next, we take a look at the summary of the use of Dietary Supplement and their safety profile. Here are some answers.
Here is the content list:
l Summary of the use of Dietary Supplement.
l Demonstrate the safety of Dietary Supplements, otherwise, they will be considered adulterated products.
To a certain extent, the use of Health food has become increasingly common and has influenced the nutritional status of populations. Therefore, the interference of Dietary Supplements should be taken into account when conducting studies on the health effects of nutrients, the efficacy of drugs, and other health-related studies. The possible confounding effects of other user-related behaviors should also be taken into account when evaluating the effects of Dietary Supplements used. In the absence of data on Dietary Supplement use in developed countries, work should be carried out as soon as possible to identify the problem and consider the influencing factors to develop appropriate intervention strategies in China. In addition, the investigation of Dietary Supplements should pay attention to the unification of concepts and methods to facilitate comparison between studies so as to obtain the maximum value of research.
Those who manufacture or distribute the dietary ingredient or Dietary Supplement should provide the Secretary with information that supports their conclusion that the Dietary Supplement containing the dietary ingredient is reasonably expected to be safe, including any references to published research. In other words, if a dietary ingredient intended for use in a Dietary Supplement is not present in the same chemical form in the food supply, an explanation must be given as to why the new dietary ingredient is considered safe for use under the conditions recommended or suggested by the label. If it is uncertain whether a dietary ingredient is a "new dietary ingredient", a notification may still be submitted. Regardless of whether a premarket notification is required, manufacturers and distributors are responsible for assessing the safety of the dietary ingredient used and must ensure that Vitamins sold or distributed are not adulterated. Sales records, sales contracts, manufacturing records, commercial invoices, magazine advertisements, or sales brochures can all be used as evidence to determine whether a dietary ingredient is new.
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Essential oils are liquid products of steam or water distillation of plant parts (leaves, stems, bark, seeds, fruits, roots and plant exudates). Expression is used exclusively for the extraction of citrus oil from the fruit peel, because the chemical components of the oil are easily damaged by heat. Citrus oil production is now a major by-product process of the juice industry. An essential oil may contain up to several hundred chemical compounds and this complex mixture of compounds gives the oil its characteristic fragrance and flavour. An essential oil may also be fractioned and sold as individual natural components. Other processing options can also produce further products that can be sold alongside essential oils. The plant parts can be extracted with organic solvents to produce oleoresins, concretes and absolutes or extracted with a near or supercritical solvent such as carbon dioxide to produce very high quality extracts. These oleoresins and extracts contain not only the volatile essential oil but also the concentrated non-volatile flavour components and these have wide application in the food and pharmaceutical industries. The solvent extraction processes are more difficult and complex than steam distillation and will normally be beyond the financial resources of most small scale processors, but supplying the raw materials to these extraction plants can be a market option.
The most important spices traditionally traded throughout the world are products of tropical environments. The major exceptions to this group are the capsicums (chilli peppers, paprika), and coriander which are grown over a much wider range of tropical and non- tropical environments. Production of spices and essential oils in these wet and humid environments brings special difficulties for crop and product management. Drying the crop to ensure a stable stored product is of particular importance, and in wet humid environments this creates the need for efficient and effective drying systems.
Health food is a supplement based on vitamins, minerals, and extracts with a relatively clear structure-activity relationship, which is taken orally to supplement essential nutrients and bioactive substances to improve health and reduce the risk of disease. The following Dietary Supplement manufacturers will introduce you to the characteristics and requirements of Dietary Supplements. Here are some answers.
Here is the content list:
l What are the characteristics of Dietary Supplements?
l What requirements must a Dietary Supplement meet?
The raw materials used in Dietary Supplement are mainly taken from natural species, but there are also safe and reliable substances produced through chemical or biological technology, such as plant and animal extracts, vitamins, minerals, amino acids, etc. Generally speaking, the physical and chemical properties of the functional ingredients are relatively stable, the chemical structure is relatively clear, the mechanism of action has been scientifically proven to a certain extent, and the safety, functionality, and quality control meet the regulatory standards.
Dietary Supplement is mainly available in the form of pharmaceutical-like products in the following dosage forms: hard capsules, soft capsules, tablets, oral liquids, granules, powders, etc. The packaging forms are pre-packaged in bottles, drums (boxes), bags, and aluminum blister packs.
Immunity increases with the status of general food can follow the requirements of the "Nutritional Labelling Regulation for Food" issued by the Ministry of Health in 2008 and label the product with nutrition or nutrient function claims. Health food products approved by the health administration can only claim the specific health functions approved, and the publication of advertisements needs to be approved by the State Drug Administration. Dietary Supplement, on the other hand, can only claim to supplement (specifically) nutrients.
Firstly, Dietary Supplement containing more than three (inclusive) vitamins and minerals can only be described as a complex or multiple Dietary Supplement. The label and instructions should indicate each content, recommended intake, method of storage and precautions, etc. Thirdly, Dietary Supplements should consist of one or more vitamins or minerals in the form of tablets, capsules, tablets, or oral liquid; the daily consumption of tablets should not exceed 20 grams and the daily consumption of oral liquid should not exceed 30 ml. Fourthly, Dietary Supplements must obtain a health food approval certificate before they can be manufactured and sold. Fifthly, the excipients added to Dietary Supplements should be mainly to enhance the product's process performance or improve the taste of the product. Sixth, the raw materials and excipients in Skin care should provide their sources and quality standards; chemically synthesized Dietary Supplement raw materials should be "Hygienic Standards for the Use of Food Additives", the relevant circulars of the Ministry of Health or the Pharmacopoeia of the types of Dietary Supplement raw materials allowed to be used and comply with the corresponding provisions, otherwise, Otherwise, it should be evaluated for safety and toxicology concerning the requirements for new food resources and provide scientific proof of safe human intake.
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They can be divided in to desired dosage strength without process or formulation changes.
When pellets containing the active ingredient are in the form of suspension, capsules, or disintegrating tablets, they offer significant therapeutic advantages over single unit dosage forms.
They can also be blended to deliver incompatible bioactive agents.
They can also be used to provide different release profile at the same or different sites in the gastrointestinal tract.
Pellets offer high degree of flexibility in the design and development of oral dosage form like suspension,sachet, tablet and capsule.
Pellets disperse freely in gastro intestinal tract (GIT), maximize drug absorption, and minimize local irritation of the mucosa by certain irritant drugs.
Improved flow characteristics: Spheres have excellent flow properties, which can be used in automated processes or in processes where exact dosing is required, e.g. tableting, moulding operations, capsule filling, and packaging.
Coating: Coating of granules is often applied for stabilizing active ingredients in the granule or to control the release of these active ingredients. Typical applications in the pharmaceutical industry are the controlled release medicines. The easiest shape to coat is the sphere due to the absence of edges. It is also the most economical one to coat as no extra coating material is required to fill irregularities in the surface of the granules.
Packing of beds and columns: In certain processes, porous beds or columns are used as chemical reactors. Spherical particles allow the reproduction of beds withalways the same void volume, surface area and permeability. Calculations and predictions of the process characteristics also become easier when round particles are used as many equations are based on flows around symmetrical bodies.
Density increase: Both the true and the bulk density of granules are increased by spheronising. This can improve the process and the packaging.
Marketing: For consumer products, spheronising is sometimes only applied for improved product appearance and marketing reasons.
Hardness and friability: Hardness and friability depend on the internal cohesive forces and surface characteristics. Spheronization increases the hardness and reduces the friability of granules. This will reduce the amount of fines generated during handling or transportation.
Plant oil is a compound made from unsaturated fatty acids and glycerol chemistry and is the oil obtained from the fruits, seeds, and germ of plants, such as peanut oil, soybean oil, flax oil, and castor oil, rapeseed oil, etc. Plant oil is obtained from oil-rich plant seed kernel as raw material, after a series of pretreatment, and then extracted by mechanical pressing or solvent leaching to obtain crude oil, which is refined. It is effective in providing energy, supplementing nutrition, treating constipation, and enhancing memory.
Here is the content list：
l Provides energy
l Supplements nutrition
l Treats constipation
l Enhances memory
l Prevent diseases
l Nutritional value
Plant oil can provide energy for the body. Plant oil contains protein and carbohydrates, which are good for the health of the body. It is also very healthy to choose plant oil when frying, and it is not easy to cause the body to gain weight.
Plant oil contains a variety of unsaturated fatty acids and vitamins, often eat plant oil, you can supplement a variety of nutrients, and eat a healthy body. Plant oil is rich in vitamins A, E, D, and K. They can meet the body's need for vitamins. Vitamin A can prevent night blindness, vitamin E can fight age, vitamin D can prevent rickets, and vitamin K is vital to the blood clotting system. In addition, plant oil is also rich in calcium, iron, potassium, and many other trace elements. Calcium is self-evident to the human body and can prevent osteoporosis, iron can prevent iron deficiency anemia, and potassium can stabilize blood pressure.
Plant oil has a digestive effect, the role of lubrication, eating is often dry and easy to form constipation, heat some plant oil can play the role of lubrication, can effectively treat constipation.
Plant oil contains vitamin E, as well as a certain amount of zinc, choline, and other components, which can help enhance memory, delay the decline of brain function, and effective anti-aging.
Plant oil is mainly composed of unsaturated fatty acids, which is different from the saturated fatty acids in animal oil. Unsaturated fatty acids will lower fat and cholesterol, which helps prevent high blood cholesterol. By the same token, plant oil is rich in unsaturated fatty acids, which can stabilize blood lipids, soften blood vessels and prevent atherosclerosis.
Plant oil mainly contains vitamin E, vitamin K, calcium, iron, phosphorus, potassium, other minerals, fatty acids, and so on. The fatty acids in plant oil can make the skin moist and shiny. The main components of palm oil and coconut oil in plant oil are saturated fatty acids, which are the same as animal fats, so they are solid at room temperature. Most plant oils, such as peanut oil, safflower oil, mustard seed oil, corn oil, flaxseed oil, nut oil, hemp oil, soybean oil, and sunflower oil, are composed primarily of unsaturated fatty acids and are therefore liquid at room temperature. It is recommended to consume those plant oils that are mainly composed of monounsaturated fatty acids. Plant oils rich in monounsaturated fatty acids include mustard seed oil, olive oil, and peanut oil. Plant oils that are high in polyunsaturated fatty acids include corn oil, safflower oil, soybean oil, sunflower seed oil, and sesame oil, all of which have a unique flavor.
The above is all the explanation of the benefits of plant oils for people in this article, and I hope it can help you to have a deeper understanding of plant oils.
Dietary Supplement products have a crucial impact on our lives, especially in the medical and food industries. Since Dietary Supplement is so important, let's take a look at the differences between Chinese and foreign Hard capsules products and their outlook. Here are some answers.
Here is the content list:
l The differences between Chinese and foreign Dietary Supplements.
l Prospective analysis of Dietary Supplement.
Firstly, Dietary Supplement has not yet become a legal definition in China, whereas it is a legal concept in the USA. Secondly, Dietary Supplement in China is a product set that straddles health food and general food, while Dietary Supplement in the United States is the third category of product that is different from general food and medicine. Thirdly, the ingredients of Dietary Supplement in China must be essential nutrients or biologically active substances with relatively clear constitutive relationships, whereas Dietary Supplement in the US does not have such a definition. Fourthly, the purpose of the Dietary Supplement in China is to improve the health of the body and reduce the risk of disease, whereas the purpose of Dietary Supplement in the USA is to supplement dietary ingredients. Fifthly, Health food in China has the status of healthy food and therefore can claim to assist in lowering blood lipids and eliminating melasma, while Dietary Supplements in the US cannot make such claims.
The most important uncertainties in the hazard characterization of Dietary Supplement presented by the US National Research Council arise from the following issues: firstly, if animal information is used, which toxicity endpoints should be considered, and which indicators of representation should be used. Secondly, what are the differences in bioavailability and dose-response relationships between animals and humans? Thirdly, if human information is used, what are the damaging effects of use, and what are the differences between dose-response relationships. Fourth, how information on subchronic exposures can be used to estimate the risk of lifetime exposure. Fifth, how information on non-dietary route exposures is used.
The information used to determine human effect levels for the Dietary Supplement is inadequate and we should focus on using appropriate techniques to better identify and quantify these parameters, such as the use of appropriate and sensitive exposure/effect biomarkers. In addition, ULs for most nutrients are formulated in terms of body weight, whereas RDAs can be expressed in terms of energy intake or unsaturated lipid intake, which raises the question of which indicator to use. The toxic effects of nutrient requirements and excesses vary according to the life cycle, for example during pregnancy.
Information on nutrient interactions and the different exposure settings of individuals has led to the recognition that for some Dietary Supplements a single NOAEL cannot be used alone and that further understanding of population differences in nutrient interactions may be useful in conducting risk assessments and determining appropriate ULs.
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The advantages of the tablet dosage form are:
1. They are unit dosage form and offer the greatest capabilities of all oral dosage form for the greatest dose precision and the least content variability.
2. Cost is lowest of all oral dosage form.
3. Lighter and compact.
4. Easiest and cheapest to package and strip.
5. Easy to swallowing with least tendency for hang‐up.
6. Sustained release product is possible by enteric coating.
7. Objectionable odour and bitter taste can be masked by coating technique.
8. Suitable for large scale production.
9. Greatest chemical and microbial stability over all oral dosage form.
10. Product identification is easy and rapid requiring no additional steps when employing an embossed and/or monogrammed punch face.
Disadvantages of tablet dosage form are:
1. Difficult to swallow in case of children and unconscious patients.
2. Some drugs resist compression into dense compacts, owing to amorphous nature, low density character.
3. Drugs with poor wetting, slow dissolution properties, optimum absorption high in GIT may be difficult to formulate or manufacture as a tablet that will still provide adequate or full drug bioavailability.
4. Bitter testing drugs, drugs with an objectionable odor or drugs that are sensitive to oxygen may require encapsulation or coating. In such cases, capsule may offer the best and lowest cost.