Long-term food consumption and body weight changes in neotame safety studies are consistent with the allometric relationship observed for other sweeteners and during dietary restrictions.

In long-term safety studies with neotame, a new high-intensity sweetener 7000-13,000 times sweeter than sucrose, the percent changes (%Delta) in body weight gain (BWG) in Sprague-Dawley rats were several-fold greater than the %Delta in overall food consumption (FC). This study investigates the question of whether the changes in BWG were adverse or secondary to small, long-term decrements in FC. The hypothesis tested in Sprague-Dawley rats was that the relationship between long-term %Delta in FC and %Delta in BWG is linear and in a ratio of 1:1.

Observations at the interface of mutation research and regulatory policy.

Between 1970 and 1975 developments in environmental mutagenesis proceeded with amazing speed. These developments were both structural and conceptual in nature. A new infrastructure was built and new concepts about how best to protect consumers from exposures to mutagens emerged.

Soy isoflavones: a safety review.

Soy isoflavones have been a component of the diet of certain populations for centuries. The consumption of soy generally has been considered beneficial, with a potentially protective effect against a number of chronic diseases; because of their estrogenic activity, however, negative effects of isoflavones have been postulated. This review examines the literature associated with the safety of soy isoflavones, including dietary soy isoflavone exposure data of populations with high soy intakes, human studies in which soy protein or isoflavones were provided, and toxicologic studies investigating the potential genotoxicity, carcinogenicity, and reproductive and developmental toxicity of soy isoflavones.

Safety evaluation of dietary aluminum.

Aluminum is a nonessential metal to which humans are frequently exposed. Aluminum in the food supply comes from natural sources, water used in food preparation, food ingredients, and utensils used during food preparations. The amount of aluminum in the diet is small, compared with the amount of aluminum in antacids and some buffered analgesics.

Toxicity and mutagenicity studies of DN-50000((R)) and RP-1((R)) enzymes.

Improved yields of 5'-nucleotides from yeast extract for food flavouring purposes is possible through use of microbial nucleotidases, which will be available to food processors as the flavour enhancer Aromild. The safety of these enzymes, 5'-phosphodiesterase (RP-1) and the 5'-adenylic deaminase (DN-50000) was investigated in male and female rats. Feeding rats a diet admixed with 500, 2000 and 8000 mg/kg body weight of DN-50000 for 35 days resulted in no significant dose-related changes in body weight, water consumption, urinalysis, haematological profiles, blood chemistry or histopathological profiles of either male or female rats from consumption of the enzyme preparation.

Evaluation of safety of inulin and oligofructose as dietary fiber.

In the United States, most individuals consume far less dietary fiber than the daily value (DV) set at 25 g. The average daily consumption for inulin and oligofructose is estimated to be between 1 and 4 g in this country, with a higher intake of 3 to 11 g seen in Europe. Inulin and oligofructose are soluble, fermentable dietary fibers, of low net caloric value having many of the possible health benefits attributed to fiber.

A review of the studies of the safety of polydextrose in food.

Polydextrose (CAS no. 68424-04-4) is a water-soluble polymer of glucose that provides to foods the bulk and texture of sucrose. There are two main forms of polydextrose, an acidic form (PD-A) and a neutralized potassium salt (PD-N).

Does the term carcinogen send the wrong message?

The term carcinogen has been used by scientists and health regulatory officials for decades. During the last 20 years there have been attempts to redefine the term to make it more rigorous. But, as predicted two decades ago by a benchmark-setting subcommittee of the National Cancer Advisory Board, advances in scientific understanding have brought about dramatic changes in the way we are able to view the term carcinogen.

Multiple chemical sensitivities: a symposium on the state of the science.

Multiple chemical sensitivities (MCS) defies diagnostic categorization because of its pansystemic manifestations, its lack of consistent symptomatology, and its absence of specific, measurable endpoints, either physical stigmata or laboratory findings. Controlled studies have been few and difficult to perform. Moreover, the phenomenon resists systematic investigation for two reasons.

How sick a patient? Report of a workshop on cancer risk assessment.

A report by the U.S. Government Office of Management and Budget (OMB) criticized the way health, safety, and environmental regulation of potential cancer causing substances is conducted by federal agencies, especially the Environmental Protection Agency.

The human relevance of the renal tumor-inducing potential of d-limonene in male rats: implications for risk assessment.

The monoterpene d-limonene is a naturally occurring chemical which is the major component in oil of orange. Currently, d-limonene is widely used as a flavor and fragrance and is listed to be generally recognized as safe (GRAS) in food by the Food and Drug Administration (21 CFR 182.60 in the Code of Federal Regulations).

Critical assessment of carcinogenic risk policy.

Fact. Cancer is a relatively common yet greatly feared disease. Belief.

FDA procedures and policies to estimate risks of injury to the male reproductive system.

Two decades ago, the Food and Drug Administration (FDA) undertook a testing and research program to study and assess the mutagenic properties of so-called "Generally Recognized as Safe" (GRAS) substances which have a long history of use in food. Initially, the program employed three highly regarded mutagenicity tests; the host mediated assay, somatic cell cytogenetics, and the dominant lethal test. Only the latter measures male germ cell events.

Nitrates: laboratory evidence.

Neither nitrate nor nitrite per se has been demonstrated to produce cancer in experimental animals. The potential carcinogenicity of either of these substances would appear to derive from their involvement in the production of carcinogenic N-nitroso compounds. The extent to which such compounds form has been the subject of numerous studies.

Beryllium: laboratory evidence.

Beryllium-containing compounds have been studied extensively and have been known to be carcinogenic in animals since 1946. Beryllium salts and alloys were among the first nonradioactive, inorganic substances shown to induce osteogenic sarcoma in experimental animals. Beryllium-containing compounds have been demonstrated to be powerful pulmonary carcinogens in rats.

Role of mathematical models in assessment of risk and in attempts to define management strategy.

Risk assessment of food-borne carcinogens is becoming a common practice at FDA. Actual risk is not being estimated, only the upper limit of risk. The risk assessment process involves a large number of steps and assumptions, many of which affect the numerical value estimated.