FDA mengetahui kesimpulan dari International Agency for Research on Cancer (IARC) dan
Joint FAO/WHO Expert Committee on Food Additives (JECFA) tentang aspartam yang
dikeluarkan pada 14 Juli 2023. Aspartam yang diberi label oleh IARC sebagai
"kemungkinan karsinogenik bagi manusia" tidak bukan berarti aspartam sebenarnya
terkait dengan kanker.
FDA tidak setuju dengan kesimpulan IARC bahwa studi ini mendukung pengklasifikasian
aspartam sebagai kemungkinan karsinogen bagi manusia. Ilmuwan FDA meninjau
informasi ilmiah yang termasuk dalam tinjauan IARC pada tahun 2021 ketika pertama kali
tersedia dan mengidentifikasi kekurangan yang signifikan dalam studi yang diandalkan
oleh IARC. Kami mencatat bahwa JECFA tidak mengangkat masalah keamanan untuk
aspartam di bawah tingkat penggunaan saat ini dan tidak mengubah Asupan Harian yang
Dapat Diterima (ADI).
Aspartam adalah salah satu bahan tambahan makanan yang paling banyak dipelajari dalam
persediaan makanan manusia. Ilmuwan FDA tidak memiliki masalah keamanan saat
aspartam digunakan dalam kondisi yang disetujui. Pemanis disetujui di banyak negara.
Otoritas regulasi dan ilmiah, seperti Health Canada (https://www.canada.ca/en/health- Atas ()
canada/services/food-nutrition/food-safety/food-additives/sugar-substitutes/aspartame-
artificial-sweeteners.html) (http://www.fda.gov/about-fda/website-policies/website-
disclaimer)dan Otoritas Keamanan Pangan Eropa
(https://www.efsa.europa.eu/en/consultations/call/110531)
(http://www.fda.gov/about-fda/website-policies/website-disclaimer)telah mengevaluasi
aspartam dan juga menganggapnya aman pada tingkat penggunaan yang diizinkan saat ini.
Pemanis atau pengganti gula, seperti aspartam, sukralosa, dan zat turunan stevia, adalah bahan
yang digunakan untuk mempermanis dan dalam beberapa kasus meningkatkan cita rasa
makanan. Beberapa pemanis jauh lebih manis daripada gula meja, dan jumlah yang lebih
sedikit dibutuhkan untuk mencapai tingkat kemanisan yang sama seperti gula dalam makanan.
Orang mungkin memilih menggunakan pemanis daripada gula karena berbagai alasan.
Misalnya, pemanis hanya menyumbang sedikit atau tidak sama sekali kalori untuk diet dan
umumnya tidak akan meningkatkan kadar gula darah.
Pemanis banyak digunakan dalam makanan dan minuman yang dipasarkan sebagai "bebas
gula" atau "diet", termasuk makanan yang dipanggang, minuman ringan, campuran minuman
bubuk, permen, puding, makanan kaleng, selai dan jeli, produk susu, dan banyak makanan dan
minuman lainnya. minuman. Konsumen dapat mengidentifikasi apakah suatu produk
mengandung pemanis dengan mencari nama pemanis pada daftar komposisi pada label produk.
FDA terus memantau ilmu terbaru yang tersedia pada pemanis dalam berbagai cara. Ilmuwan
FDA menilai kembali sains tentang paparan dan keamanan pemanis setiap kali agensi
mengajukan petisi bahan tambahan makanan atau pemberitahuan GRAS untuk pemanis
tersebut. Kami juga tetap mengikuti literatur yang diterbitkan dan tingkat paparan konsumen
saat ini dan berpartisipasi dalam kegiatan penetapan standar dan ilmiah internasional yang
terkait dengan keamanan bahan makanan.
Aspartam
Aspartame is approved
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=172.804) for
use in food as a sweetener. Aspartame brand names include Nutrasweet®, Equal®, and
Sugar Twin®. It contains calories, but consumers will likely use less than they would of
table sugar because it is about 200 times sweeter.
Aspartame is one of the most studied food additives in the human food supply. To
determine the safety of aspartame, the FDA has reviewed more than 100 studies designed
to identify possible toxic effects, including studies that assess effects on the reproductive
and nervous systems, carcinogenicity, and metabolism. FDA scientists reassessed the
science on the exposure and safety of aspartame in food each time the agency filed a food
additive petition, received relevant information from other regulatory agencies and
research institutions that have evaluated aspartame, and responded to objections that were
raised related to the approved uses of aspartame. Since the last approved use in 1996, the
FDA has continued monitoring the scientific literature for new information on aspartame.
We stay abreast of published literature and the current level of consumer exposure and
participate in international scientific and standard-setting activities related to food
ingredient safety. Other regulatory agencies have evaluated aspartame, and it is approved in
many countries.
To determine the safety of acesulfame potassium, the FDA reviewed more than 90 studies
designed to identify possible toxic effects, including studies on reproductive effects,
carcinogenicity, and metabolism.
Sukralosa
To determine the safety of sucralose, the FDA reviewed more than 110 studies designed to
identify possible toxic effects, including studies on the reproductive and nervous systems,
carcinogenicity, and metabolism. The FDA also reviewed human clinical trials to address
metabolism and effects on patients with diabetes.
Neotama
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Neotame is approved
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=172.829) for
use in food as a sweetener. Neotame is sold under the brand name Newtame® and is
approximately 7,000 to 13,000 times sweeter than table sugar.
To determine the safety of neotame, the FDA reviewed data from more than 110 animal and
human studies designed to identify possible toxic effects, including effects on the immune,
reproductive, and nervous systems.
Keuntungan
To determine the safety of advantame, the FDA reviewed data from 37 animal and human
studies designed to identify possible toxic effects, including effects on the immune system,
reproductive and developmental systems, and nervous system. The FDA also reviewed
pharmacokinetic and carcinogenicity studies, and several additional exploratory and
screening studies.
Sakarin
Saccharin brand names include Sweet and Low®, Sweet Twin®, Sweet'N Low®, and Necta
Sweet®. It is 200 to 700 times sweeter than table sugar (sucrose) and contains no calories.
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The FDA has regulated saccharin as a food additive (/about-fda/page-not-found) since
1977. First discovered and used in 1879, saccharin is currently approved for use, under
certain conditions, in beverages, fruit juice drinks, and bases or mixes when prepared for
consumption per directions, as a sugar substitute for cooking or table use, and in processed
foods. Saccharin is also listed for use for certain technological purposes.
In the early 1970s, saccharin was linked with the development of bladder cancer in
laboratory rats. This link led Congress to mandate additional studies of saccharin and the
presence of a warning label on saccharin-containing products until such a warning could be
considered unnecessary. Since then, more than 30 human studies demonstrated that the
results found in rats were irrelevant to humans and that saccharin is safe for human
consumption. In 2000, the National Toxicology Program of the National Institutes of
Health concluded that saccharin should be removed from the list of potential carcinogens.
Products containing saccharin no longer have to carry the warning label.
Certain Steviol Glycosides obtained from the leaves of the stevia plant (Stevia rebaudiana
(Bertoni) Bertoni) or fermentation-based processes
Steviol glycosides are natural constituents of the leaves of Stevia rebaudiana (Bertoni)
Bertoni, a plant native to parts of South America and commonly known as Stevia. They are
reported to be 200 to 400 times sweeter than table sugar. They are used as general-
purpose sweeteners in foods.
The FDA has evaluated many GRAS notices for the use of high purity (95% minimum
purity) steviol glycosides, including Rebaudioside A (also known as Reb A), Stevioside,
Rebaudioside D, or steviol glycoside mixture preparations with Rebaudioside A and/or
Stevioside as predominant components. FDA has not questioned the notifiers' GRAS
conclusions for these high-purity stevia derived sweeteners under the intended conditions
of use identified in the GRAS notices submitted to the FDA. The FDA's response letters on
such high purity steviol glycosides are available at the FDA's GRAS Notice Inventory
(https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices)
website.
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The use of stevia leaf and crude stevia extracts is not considered GRAS, and their import
into the U.S. is not permitted for use as sweeteners. For details, see Import Alert 45-06
(https://www.accessdata.fda.gov/cms_ia/importalert_119.html).
The safety of steviol glycosides has been extensively studied and reported in the scientific
literature (https://pubmed.ncbi.nlm.nih.gov/30268795/). In humans, steviol glycosides
are not hydrolyzed by digestive enzymes of the upper gastrointestinal tract and are not
absorbed through the upper portion of the gastrointestinal tract. Several chronic studies
and clinical studies in humans have been conducted demonstrating no adverse effects.
Extracts from Siraitia grosvenorii Swingle fruit, also known as Luo Han Guo or monk fruit
Siraitia grosvenorii Swingle fruit extract (SGFE) contains varying levels of mogrosides,
which are the constituents of the fruit primarily responsible for the characteristic sweetness
of SGFE. SGFE, depending on the mogroside content, is reported to be 100 to 250 times
sweeter than sugar. Siraitia grosvenorii Swingle, commonly known as Luo Han Guo or
monk fruit, is a plant native to Southern China. These fruit extracts are intended for use as
general-purpose sweeteners and as tabletop sweeteners.
The FDA has evaluated GRAS Notices for SGFE. The FDA has not questioned the notifiers’
GRAS conclusions for SGFE under the intended conditions of use identified in the GRAS
notices submitted to the FDA. The FDA’s response letters on SGFE are available on the
FDA’s GRAS Notice Inventory
(https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices)
website.
SGFE was the subject of a number of published studies including subchronic studies,
clinical studies, and genotoxicity studies.
Thaumatin
Thaumatin is a group of intensely sweet basic proteins isolated from the fruit of
Thaumatococcus danielli (West African Katemfe fruit). Thaumatin is intended for use as a
sweetener in various foods, including wine and other fermented or distilled beverages,
jams, ice cream, bakery items, potato-based and similar snacks, and breakfast cereals.
Thaumatin has a sweetness 2000-3000 times that of table sugar.
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The FDA has evaluated several GRAS Notices for thaumatin and has not questioned the
notifiers’ general recognition of safety conclusions for Thaumatin under the intended
conditions of use identified in the notices submitted to the FDA. The FDA’s response letters
on thaumatin are available at the agency’s GRAS Notice Inventory
(https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices)
website.
Thaumatin has been the subject of numerous published sub-chronic studies as well as
mutagenicity and allergenicity studies.
Saccharin Sweet and Low®, Sweet Twin®, Sweet'N 200 to 700 times sweeter than table
Low®, Necta Sweet® sugar (sucrose)
Steviol Glycosides Truvia®, PureVia®, Enliten® 200 to 400 times sweeter than table
sugar (sucrose)
Luo Han Guo Nectresse®, Monk Fruit in the Raw®, 100 to 250 times sweeter than table
PureLo® sugar (sucrose)
Aspartame Nutrasweet®, Equal®, Sugar Twin® 200 times sweeter than table sugar
(sucrose)
Acesulfame Potassium Sweet One®, Sunett® 200 times sweeter than table sugar
(Ace-K) (sucrose)
For each of these sweeteners, the FDA determined that the estimated daily intake of the
substance would not exceed the ADI, even when considering high exposure estimates. An
additive does not pose safety concerns if the estimated daily intake is less than the ADI. In the
case of steviol glycosides, an ADI was established by the Joint Food and Agricultural
Organization/World Health Organization Expert Committee on Food Additives (JECFA). An ()
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ADI has not been specified for monk fruit or thaumatin. An ADI may not be necessary for
several reasons, including evidence of the ingredient's safety at levels well above the amounts
needed to achieve the desired effect (such as sweetening) in food.
The chart below shows the safe limit for each sweetener and the amount a person would need to
consume to equal that limit based on its sweetness intensity.
How many packets can a person consume and still be at the safe level for each sweetener
based on its sweetness intensity?
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Number of Sweetener Packets a Person Would Need to
Examples of Brand Names Consume in a Day to Reach the Acceptable Daily Intake
Containing Sweetener Sweetener (ADI)*
Splenda® Sucralose 23
Sweet and Low®, Sweet Twin®, Saccharin 45 (sweetness intensity at 400 times sucrose)
Sweet'N Low®, Necta Sweet®
Truvia®, PureVia®, Enliten® Steviol Glycosides 9 (sweetness intensity at 300 times sucrose)
The ADI in milligrams per kilogram body weight per day (mg/kg bw/d) for the sweeteners
in the chart:
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Other Types of Sweeteners Allowed in the U.S.
The FDA permits the use of sugar alcohols, another class of sweeteners, as sugar substitutes.
Examples include sorbitol, xylitol, lactitol, mannitol, erythritol, and maltitol. The sweetness of
sugar alcohols varies from 25% to 100% as sweet as sugar. Sugar alcohols are slightly lower in
calories than sugar and do not promote tooth decay or cause a sudden increase in blood glucose.
They primarily sweeten sugar-free candies, cookies, and chewing gums.
Another class of sweeteners are sugars that are metabolized differently than traditional sugars
(/food/food-additives-petitions/sugars-are-metabolized-differently-traditional-sugars). These
sugars meet the chemical definition of a sugar, but they are metabolized, or used by the body,
differently than traditional sugars like sucrose. The FDA has evaluated GRAS notices for D-
allulose (also referred to as D-psicose), D-tagatose, and isomaltulose and has no questions about
the GRAS conclusions under certain intended conditions of use. The FDA’s response letters on
D-allulose (also referred to as D-psicose), D-tagatose, and isomaltulose are available at the
agency’s GRAS Notice Inventory (http://www.fda.gov/grasnoticeinventory) website.
Informasi Terkait
Pembaruan Konsumen: Betapa Manisnya: Semua Tentang Pengganti Gula
(/consumers/consumer-updates/how-sweet-it-all-about-sweeteners)
Timeline Kegiatan FDA Terpilih dan Peristiwa Penting Mengatasi Aspartam (/food/food-
additives-petitions/timeline-selected-fda-activities-and-significant-events-addressing-
aspartame)
EFSA: Data Ilmiah tentang Aspartam
(https://www.efsa.europa.eu/en/consultations/call/110531)
(http://www.fda.gov/about-fda/website-policies/website-disclaimer)
Gambaran Umum Bahan Makanan, Aditif & Warna (/about-fda/page-not-found)
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