Hopkins Lab Notes

From here -> http://www.hoptechno.com/book2.htm

Americans have been consuming saccharin for more than 100 years. It is - like so many other food additives - made from petroleum-based materials. Discovered by a Johns Hopkins University scientist in 1879, it was used initially as an antiseptic and food preservative.


70s Saccharin testing....

Two of the studies that followed only increased public health concerns. One was done in 1972 by the Wisconsin Alumni Research Foundation, the other in 1973 by FDA. In both tests, male and female rats were fed doses of saccharin from the time of weaning. The offspring of those rats were given saccharin for their entire lives. In both tests, the incidence of bladder tumors in the animals fed saccharin was considered significant. However, arguments were made that an impurity, not saccharin itself, was causing the tumors.

In February 1974, Canada's Health Protection Branch - FDA's counterpart there - began a major rat study to resolve the scientific uncertainties surrounding saccharin. The Canadian project, in which parent rats and their offspring were exposed to saccharin, focused on the effects of the suspect impurity in saccharin, orthotoluenesulfonamide (OTS). In early 1977, the study demonstrated that neither OTS nor other alleged culprits - bladder parasites and bladder stones - were causing the tumors. The substance responsible, the study showed, was saccharin.

*People revolted claiming that the amount of saccharin fed to the rats was equivalent to 800 cans of soda for a person.
*Took it out of contest, those rioting jerks.

Cyclamate

A cigarette placed almost unthinkingly on a pile of crystal powder led to the discovery of cyclamate by a University of Illinois scientist in 1937. When the scientist put the cigarette back in his mouth, he found that the powder, a derivative of cyclohexylsulfamic acid, had a sweet and pleasant taste. In the years that followed, the sweetener has endured both the sweet smell of success and the bitter taste of rejection.

That is...disgusting.

It was really popular until it was banned because of undeniable evidence of tumors in tests.

Abbott Laboratories, North Chicago, Ill., the sole U.S. producer of cyclamate, sought FDA's permission to re-market the artificial sweetener in November 1973, for use only in special dietary foods and for specific technological purposes. Abbott's petition included more than 400 toxicological reports, all completed after 1970, with assessments of cyclamate's carcinogenicity, mutagenicity (capability of producing genetic damage), and metabolism. In March 1976, the National Cancer Institute told FDA that Abbott's evidence did not establish or refute the cancer-causing potential of cyclamate. FDA concurred and informed the company that its evidence did not demonstrate "to a reasonable certainty" that cyclamate was safe for human consumption.

He tried again in the 80s to use it in combonation with other sweeteners but still got denied.

Aspartame

Following the 1983 approval for carbonated beverage use, some scientists and consumer groups charged that aspartame was a health hazard because it broke down and exposed consumers to excessive levels of methanol. At high enough levels, methanol is a poison and can cause blindness. It also is metabolized into formaldehyde, a "known carcinogen," the critics charged.

The critics maintained that decomposition of aspartame could occur - and expose consumers to possibly high levels of methanol and formaldehyde - if a beverage containing the sweetener was stored for long periods at high temperatures. FDA evaluated the charges and concluded "that the levels of methanol resulting from the use of aspartame in carbonated beverages did not pose any safety issues because they were well below levels of exposure expected to produce toxicity." It was also noted that other foods - including juices, fruits and vegetables - exposed consumers to higher amounts of methanol without adverse effects.

After evaluating the complaints, CDC reported in November of 1984 that, although some individuals may have an "unusual sensitivity" to aspartame products, the data obtained "do not provide evidence for the existence of serious, widespread, adverse health consequences attendant to the use of aspartame." Although a wide variety of symptoms were reported, CDC said most were mild and the kind that would be "common to the general populace."
Food Additive Regulations in the FDA;

The Food, Drug, and Cosmetic Act provides, in the now-famous Delaney Clause, tht no new food additive can be used if animal feeding studies or other appropriate tests show that it caused cancer. The Delaney Clause, however, does not apply to additives that were generally recognized by experts as safe for their intended uses. Saccharin, cyclamate and a long list of other substances were being used in foods before passage of the Delaney Clause in 1958 and were considered "generally recognized as safe" -or what is known today as GRAS. (Aspartame, on the other hand, became the first artificial sweetener to fall under the 1958 amendment's requirement for pre-marketing proof of safety because the first petition to FDA for is approval was filed in 1973.)

FDA notes

Does FD&C Yellow No. 5 cause any allergic reactions?
FD&C Yellow No. 5, or tartrazine, is used to color beverages, desert powders, candy ice cream, custards and other foods. The color additive may cause hives in fewer than one out of 10,000 people. By law, whenever the color is added to foods or taken internally, it must be listed on the label. This allows the small portion of people who may be sensitive to FD&C Yellow No.5 to avoid it.


FDA Info on additives -> http://www.cfsan.fda.gov/~dms/opa-addi.html

FDA tries to get out of its responsibility... here

Because of inherent limitations of science, FDA can never be absolutely certain of the absence of any risk from the use of any substance. Therefore, FDA must determine - based on the best science available - if there is a reasonable certainty of no harm to consumers when an additive is used as proposed.


This is unclear, but is it saying that sugar salt MSG ect. are safe by default because they were being used before the Food Additive Amendment?

Under the Food Additives Amendment, two groups of ingredients were exempted from the regulation process.
GROUP I - Prior-sanctioned substances - are substances that FDA or USDA had determined safe for use in food prior to the 1958 amendment. Examples are sodium nitrite and potassium nitrite used to preserve luncheon meats.
GROUP II - GRAS (generally recognized as safe) ingredients - are those that are generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on published scientific evidence. Among the several hundred GRAS substances are salt, sugar, spices, vitamins and monosodium glutamate (MSG). Manufacturers may also request that FDA review the industry's determination of GRAS Status.


WHAT IF SOMEONE'S ALLERGIC TO SOMETHING IN THE COLLECTIVE GROUP?! DX

But some ingredients can be listed collectively as "flavors," "spices," "artificial flavoring," or in the case of color additives exempt from certification, "artificial colors", without naming each one. Declaration of an allergenic ingredient in a collective or single color, flavor, or spice could be accomplished by simply naming the allergenic ingredient in the ingredient list.


Now this is just BS. Even if there isn't scientific proof, dietary modifications for children with ADHD can never be a bad thing.

Do additives cause childhood hyperactivity?
A No. Although this hypothesis was popularized in the 1970's, well-controlled studies conducted since then have produced no evidence that food additives cause hyperactivity or learning disabilities in children. A Consensus Development Panel of the National Institutes of Health concluded in 1982 that there was no scientific evidence to support the claim that additives or colorings cause hyperactivity. However, for some children with attention deficit hyperactivity disorder (ADHD) and confirmed food allergy, dietary modification has produced some improvement in behavior. The panel said that elimination diets should not be used universally to treat childhood hyperactivity, since there is no scientific evidence to predict which children may benefit. A 1997 review published in the Journal of the American Academy of Child & Adolescent Psychiatry noted there is minimal evidence of efficacy and extreme difficulty inducing children and adolescents to comply with restricted diets. Thus, dietary treatment should not be recommended, except possibly with a small number of preschool children who may be sensitive to tartrazine, known commonly as FD&C Yellow No.5.

Ridiculous!!

Do low-calorie sweeteners cause adverse reactions?
A No. Food safety experts generally agree there is no convincing evidence of a cause and effect relationship between these sweeteners and negative health effects in humans. The FDA has monitored consumer complaints of possible adverse reactions for more than 15 years.
For example, in carefully controlled clinical studies, aspartame has not been shown to cause adverse or allergic reactions. However, persons with a rare hereditary disease known as phenylketonuria (PKU) must control their intake of phenylalanine from all sources, including aspartame. Although aspartame contains only a small amount of phenylalanine, labels of aspartame-containing foods and beverages must include a statement advising phenylketonurics of the presence of phenylalanine.
Individuals who have concerns about possible adverse effects from food additives or other substances should contact their physicians.


All Q&A things from here -> http://www.cfsan.fda.gov/~dms/foodic.html