"Trump" U.S. dietary supplements

In the U.S., dietary supplements are really aggressive because they are almost outside the management of
FDA
, and dietary supplements are able to break free of the "shackles" of
FDA
partly because they meet the needs of the market, but also because the industry as a whole is united and fighting. To this day, while questions from the management and research levels are never out of the question, the rapid growth of the U.S. dietary supplement industry in recent years is an indisputable fact. So, at the corporate level, China's peers can only now cast an "envious" eye on Americans, while at the management level, China's health care products are the United States
FDA
want to implement, but ultimately lost to the industrial system - "safety" and "efficacy" must be approved by the government before they can be listed. So it's easier to sell a health care product to the U.S. than to list it in China.dietary supplement definitionIn the past,
FDA
used only essential nutrients, such as vitamins, minerals, and proteins, as dietary supplements.
nutrition labelling and education act

NLEA
,
1990
) of 1990 also includes "herbs or similar nutrients" in dietary supplements. This
DSHEA
(Dietary Supplements Health and Education Act) then extended the scope of "dietary supplements" to a variety of mixtures other than essential nutrients such as ginseng, garlic, fish oil, pre-car grass, enzymes, glands, and all of the above substances.DSHEA
explains the formal definition of dietary supplements with several basic requirements, namely:a product designed to supplement a diet, not tobacco, which may contain one or more dietary ingredients: one vitamin, a mineral, a herb (herb) or other plant, an amino acid, a food ingredient used to increase the total daily intake to supplement the diet, or a concentrate, metabolite, ingredient, extract, or combination of the above ingredients;Products may be in the form of pills, capsules, tablets or liquids, cannot replace regular food or are the only variety of meals, are labeled as "dietary supplements", are approved new drugs, a licensed antibiotic or a licensed biological agent, such as products that were listed as dietary supplements or food products before they were approved, licensed, licensed (except where the U.S. Department of Health and Human Services
SHHS
exempts from this provision).SafetyDSHEA
amended the original
FD-C Act
(U.S. Federal Food, Drug, and Cosmetic Act) provision on food fraud. According to
DSHEA
, a dietary supplement is considered a fake product if it itself or some of its ingredients are consumed under label instructions or under normal circumstances (e.g. without instructions to eat) with a clear or excessive risk of disease or injury. New food ingredients contained in a dietary supplement (e.g.,
1994-

15
food ingredients not listed in the United States as dietary supplements) are also considered false if there is insufficient information to ensure that they do not cause a significant or excessive risk of illness or injury. The U.S. Department of
And Human services
released which dietary supplements or food ingredients pose a direct risk to human health and safety. However, as with other foods, it is the producer's responsibility to ensure the safety of the product before it is marketed and the correct labelling.DSHEA
provides access to "third-party" materials that help consumers understand the health benefits of dietary supplements. It includes articles, excerals, scientific abstracts, or other third-party publications.
DSHEA
specifically emphasizes that such information must not be false or misleading, that it must not be advertised against a product brand, that a scientifically balanced view must be presented with other materials, that it must be separated from the product, and that no other information (e.g. product promotional materials, etc.) may be attached to the product.Nutrition Argument DSHEA
makes various types of statements that may be used on dietary supplement products, provided that they are not (promoted) in the relationship between a dietary supplement and the diagnosis, prevention, mitigation and treatment of the disease (unless the provisions on the new drug have been approved by
FD-C Act
). For example, a product may not claim to "cure cancer" or "treat arthritis". Several health promotions approved by
FDA
, such as "Folic acid and reduce the risk of neural tube defects in newborns" and "Calcium and reduce the risk of osteoporosis", can be used in products that meet the promotional requirements as a supplement to the label. According
DSHEA
, manufacturers can also present information on nutrient deficiencies on their products, as long as these instructions provide information on the incidence of such diseases in the United States. In addition, manufacturers can also promote the impact of dietary supplements on the structure and function of the body, and even overall health. In doing all of the above publicity, the manufacturer must provide information to verify its authenticity and not mislead consumers, and the product label should be accompanied by the words: "This product has not been evaluated by the
FDA
and this product cannot be used to diagnose, treat or prevent disease." This kind of nutritional promotion does not need to be approved by the FDA
before the product
, which is different from "health promotion".ingredient identification and nutritional information , dietary supplements, like other products, must have ingredient labels. It includes the name and dosing of each food ingredient, and for composite products, there should be a total of all dietary ingredients (excluding inactive ingredients). The product label should have the words "Dietary Supplements" (e.g., "vitamin
C
dietary supplements"). If there are herb ingredients in the product, the plant site where the ingredients are sourced should be stated. If a dietary supplement is one of the official specifications (which includes the American Pharmacopeia, the American Homeopathic Pharmacopeia, the National Prescription Set, etc.), it must comply with its specifications. If it is not a variety in the above-mentioned official specification catalogue, this dietary supplement must also be consistent with the label and have the indicated effect.should also have a nutritional label on the product label. The nutritional label lists the dietary components
FDA
that determine the recommended daily intake values, and the ingredients that do not have the recommended daily intake values are listed later. Dietary ingredients with low dosing do not need to be labeled. Nutritional labels also include the content of each dietary ingredient in each serving and the source of that dietary ingredient (e.g., "calcium comes from calcium glucosate"). Ingredients identified in the nutrition label do not need to be listed in the ingredient label. In the product label, the nutritional label should be before the ingredient identification.other provisions national dietary ingredients new dietary supplements are substances that were not listed in the United States before
1994

1015
). These substances are added to food to ensure that the chemical properties of the original food do not change, or that they are used in the past and under recommended conditions to ensure that the product is safe enough. Manufacturers of such products are required to apply to the
FDA

75
days before the listing, and the submission should, to the extent possible, enable the
FDA
to conclude that the product is "safe enough".Good Manufacturing Process
(GMP) DSHEA
proposed that the
FDA
be responsible for drafting
GMP
regulations on the preparation, packaging and storage of dietary supplements to ensure their safety. This regulation can be developed after the
GMP
other products are implemented.
fda is
to work with other industry sectors and stakeholders to develop it and to consult the public at that time. Dietary Supplements Committee DSHEA
requested the establishment of a Dietary Supplements Committee to conduct research and labelling management on dietary supplements and to develop procedures for evaluating functional advocacy. Members of the Committee should determine how best to evaluate product advocacy as true, scientifically valid and not misleading to consumers in order to enable them to make informed and correct choices. Members of the Committee include personnel from all parties involved in production, research, management, sales and use. Dietary Supplements Health and Education Act the Food, Drug, and Cosmetics Act of
1938 gives the
FDA
the authority to manage dietary supplements. According to
FDA
, if a food ingredient is claimed to treat, prevent, or improve the structure and function of the body, it is a "drug" that cannot be sold as casually as food.
1950s


, they took hundreds of actions against "dietary supplements" that claimed various functions, but still failed to slow the expansion of the industry. In 1973 and
, the
FDA
announced a new policy: supplements that "have no nutritional necessity", such as vitamins that exceed normal demand, need to be approved for sale as drugs; The plan was opposed by producers and consumers, and Congress "conformed to public opinion" by passing the Vitamin Minerals Amendment

1976. According to the
,
FDA cannot "manage vitamins and minerals as drugs simply because they exceed normal demand." 1985
,
the FDA
suffered another setback. At the time, one company claimed that "high-fiber foods may reduce the risk of certain cancers".
FDA
is prepared to sue it, and the Federal Trade Commission, which supports the claim, defended the recommendation as "accurate, useful" and "scientifically based" because it was recommended by the National Cancer Institute.
the FDA
to back down, agreeing that dietary supplements can claim "scientifically based" functions. 1989
a tryptophan supplement killed at least 38
,
people.
kessler
, then the
FDA's director of
, thought the opportunity to turn things around came when he announced in
in
1993 that he would not approve any function of dietary supplements and that supplements other than vitamins and minerals would be treated as drugs. the U.S. dietary supplement industry fought back, launching a dramatic mass campaign to "defend people's right to eat dietary supplements."
parliamentary elections
the end of 1994. During the campaign, lawmakers recognized the sensitivity of the issue. Lawmakers who had previously been the strongest opponents of dietary supplements in Congress have also made a compromise gesture. Industry drafted a bill that many thought was difficult to pass. What's surprising is that, in the run-up to the congressional elections, the final text was a success. this is the Dietary Supplements Health and Education Act
DSHEA
). Comments on the bill so far have been sororated, with most
that
fda's regulatory authority over dietary supplements has been significantly weakened. Under the act, the effectiveness and safety of dietary supplements are guaranteed by the manufacturers themselves and cannot be
in
FDA approval to go on sale.
FDA
banned its sale only after "unsafe evidence" has been obtained.
the fda
regulatory function is left with a fight against "false propaganda", such as claims that "natural products" are added to drug ingredients, or claims of "disease prevention and treatment". Manufacturers cannot claim "therapeutic effects", such as "treatment of osteoporosis", but can claim to affect "body structure and function", such as "helping to increase bone density". But there was a gray space between the two, which became the main
the FDA
the FDA's warning. after
DSHEA
, the U.S. dietary supplement industry has seen unprecedented growth. Manufacturers do not
the FDA
to declare the "functionality" of the product. Simply state that the feature is "not
FDA
review" and that the product is "not intended to diagnose, treat, treat or prevent any disease." And safety,
fda
simply can't be censored. As long as you don't eat the immediate harm,
FDA