l**********r
发帖数: 335 | 1 FDA approval问题
一般的美国消费品，如何知道到底FDA批准没有，有没有具体的文献检索例如像专利一
样的查找方式看到底FDA批复的具体claim
多谢，包子准备着。 | t**n
发帖数: 4365 | 2 FDA网站上就有解释
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm
"FDA approved": Maybe you saw the words on a company's Web site or in a
commercial promoting a new product or treatment. Some marketers may say
their products are "FDA approved," but how can you know for sure?
FDA is responsible for protecting the public health by regulating human and
animal drugs, biologics (e.g. vaccines and cellular and gene therapies),
medical devices, food and animal feed, cosmetics, and products that emit
radiation.
But not all of these products undergo premarket approval—a review of safety
and effectiveness by FDA experts and agency approval before a product can
be marketed. In some cases, FDA's enforcement efforts focus on products
after they are already on the market. This is determined by law.
The following facts can shed light on when the term "FDA approved" is
appropriate after such a determination is made by the agency.
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FDA does not approve companies.
FDA does not "approve" health care facilities, laboratories, or
manufacturers. FDA does inspect product manufacturers to verify that they
comply with good manufacturing practices.
Owners and operators of domestic or foreign food, drug, and most device
facilities are required to register with FDA. Blood and tissue facilities
also must register with the agency.
Mammography facilities must be FDA certified. Mammography facilities are
required to display their FDA certificates where patients can see them. The
certificate indicates that the facilities have met stringent standards and
can provide quality mammography.
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FDA approves new drugs and biologics.
New drugs and biologics must be proven safe and effective to FDA's
satisfaction before companies can market them. FDA does not develop or test
products; FDA experts review the results of laboratory, animal, and human
clinical testing done by manufacturers.
If FDA grants an approval, it means the agency has determined that the
benefits of the product outweigh the risks for the intended use.
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FDA does not approve compounded drugs.
Pharmacy compounding is an age-old practice in which pharmacists combine,
mix, or alter ingredients to create unique medications that meet specific
needs of individual patients. It's also a practice that is under FDA
scrutiny—mainly because of instances where compounded drugs have endangered
public health. In its traditional form, pharmacy compounding is a vital
service that helps many people, including those who are allergic to inactive
ingredients in FDA-approved medicines. But consumers need to be aware that
compounded drugs are not FDA-approved. This means that FDA has not verified
their safety and effectiveness. Poor practices on the part of drug
compounders can result in contamination or in products that don't possess
the strength, quality, and purity required.
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FDA uses a risk-based, tiered approach for regulating medical devices.
FDA classifies devices according to risk. Only the highest-risk devices,
such as mechanical heart valves and implantable infusion pumps, require FDA
approval before marketing. To receive FDA approval for these devices, the
manufacturer must demonstrate that its devices provide a reasonable
assurance of safety and effectiveness.
Moderate-risk medical devices (e.g., dialysis equipment and many types of
catheters) are cleared for marketing based on an FDA determination that they
are substantially equivalent to an already legally marketed device of the
same type.
FDA has exempted certain low-risk medical devices (e.g., certain bandages)
from premarket review when they are for the same use and of the same
technology.
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FDA approves additives in food for people.
FDA field investigators inspect food companies, examine food shipments from
abroad, and collect samples. Laboratory scientists analyze samples.
Compliance officers recommend legal action and follow through on enforcement
issues. What undergoes premarket approval? New food additives and color
additives must be approved before they can be used in foods. These additives
are considered food under the law.
New food additives, including substances added intentionally to food and
substances that may migrate to food because they contact food (e.g., food
packaging) must be shown to be safe to FDA's satisfaction before companies
can market them.
Companies that want to add new additives to food bear the responsibility of
providing FDA with information demonstrating that the additives are safe.
FDA experts review the results of appropriate tests done by companies to
ensure that the additive is safe for its intended use.
An approved food additive must be used in compliance with its approved uses,
specifications, and restrictions. Certain food ingredients, such as those
with a long history of safe use in food, do not require premarket approval.
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FDA approves drugs and additives in food for animals.
FDA is responsible for approving drugs and food additives given to, or used
on, over one hundred million pets, plus millions of poultry, cattle, swine,
and minor animal species. (Minor animal species include animals other than
cattle, swine, chickens, turkeys, horses, dogs, and cats.)
FDA does not approve pet food, but rather approves the food additives that
are used in pet food. FDA has the authority to take action against pet food
products that are in violation of the law.
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FDA approves color additives used in FDA-regulated products.
This includes those used in food, dietary supplements, drugs, cosmetics, and
some medical devices. These color additives (except coal-tar hair dyes) are
subject by law to approval by the agency, and each must be used only in
compliance with its approved uses, specifications, and restrictions.
In the approval process, FDA evaluates safety data to ensure that a color
additive is safe for its intended purposes.
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FDA does not approve cosmetics.
Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair
dyes, face and body cleansers, and shaving preparations.
Cosmetic products and ingredients do not require FDA approval before they go
on the market, with one exception: color additives (other than coal tar
hair dyes.) Cosmetics must be safe for their intended use and properly
labeled.
FDA field investigators inspect cosmetic companies, examine imports, and
collect samples for analysis. FDA may take action against non-compliant
products, or against firms or individuals who violate the law.
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FDA does not approve medical foods.
A medical food is used for the dietary management of a disease or health
condition that requires special nutrient needs. An example of a medical food
is a food for use by persons with phenylketonuria, a genetic disorder. A
person with this disorder may need medical foods that are formulated to be
free of the amino acid phenylalanine. A medical food is intended for use
under the supervision of a physician.
Medical foods do not have to undergo premarket approval by FDA. But medical
food firms must comply with other requirements, such as good manufacturing
practices and registration of food facilities. Medical foods do not have to
include nutrition information on their labels, and any claims in their
labeling must be truthful and non-misleading.
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FDA does not approve infant formula.
FDA does not approve infant formulas before they can be marketed. However,
manufacturers of infant formula are subject to FDA's regulatory oversight.
Manufacturers must ensure that infant formula complies with federal nutrient
requirements. Manufacturers are required to register with FDA and provide
the agency with a notification before marketing a new formula.
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FDA does not approve dietary supplements.
Unlike new drugs, dietary supplements are not reviewed and approved by FDA
based on their safety and effectiveness. Most dietary supplements that
contain a new dietary ingredient (a dietary ingredient not marketed in the
United States before October 15, 1994) require a notification to FDA 75 days
before marketing.
The notification must include the information that was the manufacturer or
distributor's basis for concluding that the dietary supplement will
reasonably be expected to be safe. After dietary supplements are on the
market, FDA evaluates their safety through research and adverse event
monitoring.
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FDA does not approve the food label, including Nutrition Facts.
FDA does not approve individual food labels before food products can be
marketed. But FDA regulations require nutrition information to appear on
most foods, including dietary supplements. Also, any claims on food products
must be truthful and non-misleading, and must comply with any special
requirements for the type of claim.
Manufacturers are required to provide the serving size of the food and
information about the nutrient content of each serving on the "Nutrition
Facts" panel of the food label (or on the "Supplement Facts" panel for
dietary supplements.)
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FDA does not approve structure-function claims on dietary supplements and
other foods.
Structure-function claims describe the role of a food or food component (
such as a nutrient) that is intended to affect the structure or function of
the human body. One example is "calcium builds strong bones."
Dietary supplement firms that make structure-function claims on labels or in
labeling must submit a notification to FDA. This notification must be
submitted no later than 30 days after marketing the dietary supplement with
the structure/function claim. Additionally, the notification must include
the text of the claim, as well as other information, such as the name and
address of the notifier. FDA does not require conventional food
manufacturers to notify FDA about their structure-function claims.
Structure-function claims on dietary supplements carry a disclaimer stating
that the claim has not been reviewed by FDA, and that the product is not
intended to diagnose, treat, cure, or prevent any disease. Conventional
foods are not required to carry such a disclaimer.
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Misuse of FDA's logo may violate federal law.
FDA's logo should not be used to misrepresent the agency nor to suggest that
FDA endorses any private organization, product, or service.
This article appears on FDA's Consumer Updates page, which features the
latest on all FDA-regulated products.
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【在 l**********r 的大作中提到】
: FDA approval问题
: 一般的美国消费品，如何知道到底FDA批准没有，有没有具体的文献检索例如像专利一
: 样的查找方式看到底FDA批复的具体claim
: 多谢，包子准备着。
| l**********r
发帖数: 335 | 3 大侠的链接我也看了，就是感觉难道FDA基本就是出问题了才检查保健品。
不过到底是美国公司美国内都基本按规矩办事，否则三鹿遍地走了。
你的签名好cute，spanking is fun， 哈哈。
and
safety
【在 t**n 的大作中提到】
: FDA网站上就有解释
: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm
: "FDA approved": Maybe you saw the words on a company's Web site or in a
: commercial promoting a new product or treatment. Some marketers may say
: their products are "FDA approved," but how can you know for sure?
: FDA is responsible for protecting the public health by regulating human and
: animal drugs, biologics (e.g. vaccines and cellular and gene therapies),
: medical devices, food and animal feed, cosmetics, and products that emit
: radiation.
: But not all of these products undergo premarket approval—a review of safety
| H**P
发帖数: 90 | 4 我的理解，保健品属于食品范畴，FDA不评价他的功能，但要求厂商报备。至于批准信
息，没查过，但一般政府可以提供free sale certificate，或者certificate for
Foreign Government吧，但得厂商得自己去管政府部门要求。 |
|
