Health food function scope adjustment scheme
Posted on November 30th, 2011 in health and fitness current events | Comments Off
health food function scope adjustment scheme
(drafts)
for carrying out the “food safety law and its implementing regulations shall exercise strict supervision of health food requirements, further perfect function evaluation methods, improve the judgment standard, standardizing function says, strictly admittance threshold, now for health food function adjustment range put forward the following plan:
an, function setting principle
(a) in the Chinese traditional health care theory and modern medical theory as the guide, to meet people, to improve human health care needs for the purpose.
(2) function orientation should regulate the function, reduce the disease risk factors, in particular the crowd, not to treat the disease for the purpose.
(3) function claims should be recognized the scientific community, it is scientific, pertinence, applicability, function name should be scientific, accurate, easy to understand.
(4) function evaluation method and the judgment standard 3 g phone should be scientific, recognized and feasible.
(5) function and management should be adjusted according to scientific development, social demand and regulatory practice, according to related procedure, the implementation of the dynamic management.
2, function adjustment principle
(a) comply with the principle of health food function setting.
(2) adjust to the existing function, insist on a smooth transition to promote the gradual, temporary don’t add new functions.
(3) with similar functions, standardizing function name, make it more in line with the health care food features, more targeted.
(4) according to the scientific development, improving the appraisal method, an appropriate increase in the judgment standard, strengthening human try food test and scientific literature basis.
(5) cancel or adjust the function orientation was not accurate enough, says science is not strong, the easy and disease treatment and mislead consumers confused the function; Cancel the lack of objective evaluation index, the lack of social demand function.
(6) according to the function orientation and evaluation method, and the Brand bags the whole appropriate crowd range.
three, specific adjustment scheme
according to the function set up and adjust the principle, the existing 27) function cancel the five, involving the four gastrointestinal function into 1 item, involving improve facial skin metabolism of two for a merger shall be maintained, the final determination for 18 major function. Specific adjustment as follows:
suggest keep function:
(1) enhance immunity
keep reason:
1. The function name change for help to enhance immunity.
2. Evaluation of test the immune function by mouse lymphocyte transformation test, reacts, antibody generating cells, serum hemolysin test, carbon clearance NK cells in mice, the activity of immune and so on a test index, with the current of the basic theory of immunology is consistent, covering the cellular immune, humoral immune and nonspecific immunity and so on the immune function of the main mechanisms, and the choice of model and index extensively used in China and abroad, in the effect evaluation has also been widely recognized by the feasibility.
3. When using can be used for health food items list of raw materials, less/children as not appropriate crowd. When appropriate crowd include young children, should be limited to the materials in accordance with the traditional food or both food and Chinese herbal medicine material, in order to increase the safety.
raise the standard advice:
animal testing: increase the peripheral blood white blood cells determination indicator; ConA induced in mice of spleen lymphocyte transformation in Brdu increase with mark test method; Late onset allergy (DTH) increase foot zhi volume measurement; Improved detection method antibody generating cells; Serum hemolysin increased serum determination of trace reaction method, increase mononuclear-of macrophage cell fluorescence microspheres test; Cancel the abdominal macrophage cell chicken red blood cell trial; Increase immune suppression model method.
will enhance immunity function results judgment is amended as: normal animal experimental results judgment and immune function is lower in the animal model experimental results judgment.
improve normal animal experimental results judgment standard: in addition to the activity of NK cells the judgment, the cellular immune, humoral immune, monocyte-macrophages function measurements, need to two experiments of the results are all positive, to be able to judge the test positive for; Increase immune function is low animal experimental results judgment.
human try food test: due to ethics reason, and test cycle is long, the influence factors, the results variability, test the crowd compliance is poor, are not increase the body’s try food test.
increase of research literature on human test requirements.
(2) auxiliary cholesterol-lowering
keep reason:
1. The function name change for help to reduce the blood fat, and function setting principle is consistent.
2. Using mixed hyperlipidemia animal model, high cholesterol animal model, the choice of the health effects end blood fat index (triglycerides, total cholesterol) to evaluate, try eating the use of human body of strict randomized, placebo-controlled human test design. Choice of model, design and index extensively used in China and abroad, in the effect evaluation has also been widely recognized by the feasibility.
existing detection means and technology index, mature, feasible, triglycerides, total cholesterol levels index set up has the scientific nature.
raise the standard advice:
animal testing: to establish pure high cholesterol animal models, including high fat feed formula and animal strains of choice; Increase the monitoring indicators, such as LDL.
human try food test: reduce the blood fat increase single index test meal plan; Will be divided into most people try and triglyceride high cholesterol two classes; Try to eat observation period extended 2-six/; Strengthen the control of the test conditions, such as increasing the detailed records meal; Try to human food the judgment standard to test revised, total cholesterol, triglyceride respectively formulate the judgment standard.
(3) auxiliary fall blood sugar
keep reason:
1. The function name change for help to reduce blood sugar, and the function of the setting principle is consistent.
2. The choice of the health effects end fasting blood glucose, after eating glucose tolerance index evaluation, evaluation function using universal and traditional test model, and the human body the use of a rigorous test meal of randomized, placebo-controlled human trial design, can reflect the objective health food helps to the effect that reduce blood sugar.
raise the standard advice:
animal testing: to establish high sugar and fat with insulin resistance metabolic disorder model, closer to the human body the pathophysiological state.
human try food test: increase of serum total cholesterol, triglyceride, saccharification serum protein indicator; Try food increased to 2-observation period four months; Should have more detailed records of the meal.
(4) to improve sleep
keep reason:
1. The function name change for help to improve the sleep, and function setting principle is consistent.
2. At present to improve sleep evaluation using universal model, including extended sodium pentobarbital sleep time, sodium pentobarbital (benzodiazepines sodium) under hypnosis test, threshold dose benzodiazepines sodium sleep latency period test, accord with the basic theory of sleep, chose to sleep for the index, extensively used in China and abroad, in the effect evaluation has also been widely recognized by the feasibility.
raise the standard advice:
increase the body’s try food test.
(5) antioxidant
keep reason:
1. The function name reserves, and the function of the setting principle is consistent.
2. Antioxidant function evaluation animals in the experiment, natural aging model establishment and the D-half of lactose model, ethanol oxidative damage model, for general evaluation anti-oxidation animal model, the human body in the experiment, the rigorous test meal randomized, placebo-controlled human test design. Existing MDA content index of lipid peroxidation, antioxidant enzymes index (SOD, GSH-Px), in addition to increasing the 8-table oxygen-different prostaglandin (8-iso-PGF2 alpha, protein, nucleic acid damage, and other indicators of carbonyl. These indicators to oxidative damage theory basis for the free radicals, and academic circles to oxidative damage caused effect on the health of the mainstream view are in agreement. Choice of model and index extensively used in China and abroad, in the effect evaluation has also been widely recognized by the feasibility.
raise the standard advice:
animal testing: cancel bromination benzene model and irradiation animal model, increase ethanol oxidative damage model; Increases in serum lipid peroxidation detection 8-table oxyhydrogen different prostaglandin, carbonyl index and blood and tissue reducing glutathione indicator; Test time 30 days and, when necessary, can be extended to 45 days.
human try food test: participants aged 18-65 years old. Increases in serum 8-table oxyhydrogen different prostaglandin index for optional; Try food observation period extended to 3 to 6 months.
(6) the alleviation physical fatigue keep reason: