- Click here for explanation of classification scheme.

Review of intake of aspartame vs. acceptable daily intake.

• Electronc databases such as Medline, chemical abstracts, science citation index, biosis, food science and technology abstracts, agricola, toxline
• 1970 to 2002
• Published worldwide in peer-reviewed journals
• Scientists as reviewers
• Search terms: Aspartame, Nutrasweet, aspartic acid, phenylalanine, methanol, diketopiperazine.
  

Not meeting inclusion above.

Review of history and articles.

Information from 1970 to 2002.

Human studies with a few references to animal outcomes.

Prior to Regulator Approval

• Extensive toxicologic and pharmacologic research was done in laboratory animals, using much greater doses of aspartame than people could possibly consume.
• Toxicology studies showed no observed effect level at least 4,000mg/kg of body weight. This was established for aspartame by the Scientific Committee for Food (SCF) in 1985, the Canadian Health Protection Branch in 1979 and the Joint FAO/WHO Expert Committee on Food additives in 1980.
• An acceptable daily intake of 40mg/kg of body weight was established for aspartame based on these results. When aspartame was first approved by the US, the FDA established an ADI of 20mg/kg of body weight (1974).

Human Subjects

• Humans were assessed in several groups: Healthy infants, children, adolescents and adults; obese individuals, diabetics, lactating women and individuals heterozygous (PKUH) for the genetic disease phenylketonuria (PKU) (who have a decreased ability to metabolize the essential amino acid, phenylalanine).
• The FDA used these additional data from humans and increased the ADI for aspartame to 50mg/kg of body weight in 1983 (FDA, 1984).

Safety Evaluation

• Regulators evaluate projected use levels relative to the ADI. If projected levels approach or exceed the ADI, restrictions may be imposed.
• Before approval in the US, projected averaged intakes ranged from 8.3mg/kg of body weight per day, if all sucrose in an average-sized person’s diet was replaced by aspartame, to 25mg/kg of body weight per day, if all dietary CHO was replaced by aspartame.
• 12,000 individuals' dietary records were analyzed. It was estimated that if possible foods were replaced with aspartame-containing foods, the 99th percentile daily consumption of aspartame would be 34mg/kg of body weight (FDA, 1981). Initially, FDA considered the 99th percentile of estimated intake as representative of high-level consumers. Due to the projections that the 99th percentile may have large and variable intakes which may skew the data, the FDA currently uses the projections of the 90th percentile.

Aspartame Intake in the US

• 1981: Was approved by the FDA for use in dry applications (e.g., table-top, gelatins) in 1981
• 1983: Approval in carbonated soft drinks
• 1984: About 30% of the US population was estimated to consume aspartame
• MRCA Information Services began monitoring aspartame in the US
• 1984-1992: Detailed menu census surveys from over 2,000 households per year were monitored for a 14-day survey. Data were collected by age group: Zero to 23 months, two to five years, six to 12 years, 13 to 17 years and 18 years or over, as well as all age groups together. Children's intake was of concern, due to their smaller body weights, as they may consume more of an additive on a milligram-per-kilogram basis than adults.

MRCR Data: Aspartame Intake (mg/kg of Body Weight per Day) in US; 90th percentile; 14-Day Average for Eaters from 1984 to 1992; Butcko et al, 1994

Dates of Survey	General Population	Two to Five Years	Individuals on a Reducing Diet	Women of Childbearing Age	Diabetics
1984-1985	1.6	3.1	1.6	2.0	2.1
1985-1986	2.1	4.8	2.2	2.2	2.2
1986-1987	2.2	3.7	2.3	2.5	3.0
1987-1988	2.3	2.6	2.6	2.8	3.3
1988-1989	2.2	4.0	2.5	2.6	2.6
1989-1990	2.5	3.1	2.7	3.2	2.7
1990-1991	2.8	3.5	2.8	3.7	3.4
1991-1992	3.0	5.2	3.3	4.2	3.3

• Average daily intake over the 14-day period for the general population of aspartame eaters at 90th percentile ranged from 1.6 to 3.0mg/kg of body weight per day from 1984 to 1992.
• Children, diabetics, weight-reduction people and females of childbearing age consumed about 5% to 10% of the ADI in the US (50 mg/kg of body weight). Other data from the USDA on CSFII have found similar results.
• Thomas-Doberson, 1989, 1990, calculated aspartame intake by children from products, estimating how many servings of different products would need to be consumed to obtain intake at the ADI (50 mg/kg of body weight per day in the US) and at 34 and 17mg/kg of body weight per day. This article was criticized for raising safety issues with incomplete citation of the literature. Actual intakes by children is about 10% of the ADI in the US.
• Butchko and Kotsonis, 1996, asparatame intakes
• Adults: 2% to 3% of daily dietary intake of aspartate and phenylalanine, respectively
• Children: About 1% of both aspartate and phenylalanine.

European Countries

• Finland
  Virtanen et al, 1988: Almost three quarters of the diabetic children surveyed in Finland consume asparatame-containing products. Mean intake was 1.15mg/kg of body weight per day, less than 3% of the ADI in Europe (40mg/kg of body weight).
• France
  Chambolle et al 1994: Reported that from 1991 to 1992 intake was 0.6 and 1.0mg/kg of body weight per day at the 90th and 95th percentiles. Study was limited due to no data for food consumed outside the home and some categories were missing.
  Garnier-Sagne et al 2001: Insulin-dependent diabetic children from two to 20 years of age were evaluated with a five-day dietary questionnaire. Intakes were mean 2.4, 97.5th percentile, 7.8 and maximum 15.6mg/kg of body weight per day. All sugar-free products were assumed to contain only one sweetener at its maximum level, whereas many products are blends of several sweeteners.
• Germany
  Bar and Biermann, 1992: Survey conducted from 1988 to 1989 found the 90th percentile average daily intake was 2.75mg/kg of body weight per day for aspartame.
• Italy
  Leclercq et al, 1999: Teenagers who were known to be users of diet products had estimated average intakes of aspartame of 0.03mg/kg of body weight per day. Maximum intake was 0.39mg/kg of body weight per day.
• Netherlands
  Hulshof and Bouman, 1995: Food frequency questionnaire found mean estimated intake was 2.4mg/kg of body weight per day. Intake at the 95th percentile was 7.5mg/kg of body weight per day. Food intake records showed the mean and 95th percentile intakes were 1.9 and 7.5mg/kg of body weight per day, respectively.
• Norway
  Bergsten 1993: Average estimated intake varied from 0.9 to 3.4mg/kg of body weight per day among males and females of various age groups.
• United Kingdom
  Hinson and Nicol, 1992: Survey from 1988 found aspartame consumption at the 90th percentile was 4% of the ADI (40mg/kg of body weight per day). Children and diabetics ingested about 7% and 6%, respectively.
• MAFF, 1995: In 1994, the 97.5th percentile of asparatame consumption in diabetics who would likely be frequent consumers of aspartame was about 10.1mg/kg of body weight per day, only 25% of the ADI.

Other Countries

• Australia
  Australia National Food Authority, 1995: Mean consumption was about 6% to 7% of the ADI for a seven-day survey.
• Brazil
  Toledo and Ioshi, 1995: Aspartame intake at the median by users of intense sweeteners was 2.9% of the ADI. Intakes at the median by diabetics and individuals on weight-control diets were 1.02mg/kg of body weight per day (2.6% of the ADI and 1.28mg/kg of body weight per day (3.2% of the ADI).
• Canada
  Heybach and Ross 1989: General population of aspartame eaters consumed 5.5mg/kg of body weight per day during cold weather months and 5.9 during warm weather months in 1987. Children and special populations consumed from 5.5 to 11.4mg/kg of body weight per day.

Table One: Approximate Aspartame Content of Some Common Foods and Beverages

Food	Serving Size	Aspartame Content (mg)
Beverage	12 fluid ounces (355ml)	180
Yogurt	Eight fluid ounces (240ml)	125
Hot Chocolate	Six fluid ounces (180ml)	50
Table-top Sweetener	One packet	35
Pudding Dessert	Four fluid ounces (120ml)	25

• Surveys with over 5,000 individuals per year were done from 1984 to 1992 to monitor intake levels of aspartame in the US. Average daily aspartame intake at the 9th percentile in the general population ranged from about two to three mg/kg of body weight per day over the surveys. Intake by two- to five-year-old children ranged from 2.5 to five mg/kg of body weight per day. Aspartame intake was monitored in seven European and other countries.
• Although survey methodologies may have been different, aspartame intake was consistent across studies and well below the ADI.

Government:	Veterans Affairs
Industry:	NutraSweet Company; Cantox Health Sciences, Inc., Graystone Associates Food Company: Other:
University/Hospital:	University of Heidelberg (Germany); Vrije Universiteit (Netherlands); Harvard Medical School; University of Cincinnati; Ohio State University of Veterinary Medicine; University of Minnesota, Eastern Michigan University; Louisiana State University Medical Center; Yale University of Medicine; Universi