artificial sweetener gets fda approval

1
Japanese plan first European fiber plant Japan's first move into synthetic fiber making in Europe has come in Ireland's County Mayo. Asahi Chemical Industries is the leading shareholder in two joint ventures to produce acrylic fiber and yarn at Ballina. Hong Kong's Textile Alli- ance, Ltd., is Asahi's major part- ner. With approvals by both the Jap- anese and Irish governments in hand and a site purchased, one venture will put an 18,000 metric- ton-per-year fiber unit on stream about June 1976. The other will bring an adjacent spinning plant capable of making 2500 tons a year of acrylic yarn into operation at the same time. Technology will come from Asahi Chemical, Japan's number one acrylic fiber maker. At home, the company produces all three major synthetic fibers, but acrylic is its largest profit maker. Asahi has sold equipment and technology abroad in the past, but has been slower to invest overseas than have such other leading Japanese fiber firms as Teijin and Toray Industries. Last year, however, it set up Asahi Chemical International as a subsid- iary to evaluate and organize for- eign ventures. The company holds a 45% inter- est in Asahi Synthetic Fibres (Ire- land); Textile Alliance owns 35% and Japan's Toray Industries 10%. Toray's interest stems from its po- sition as the main shareholder (about 30%) in Textile Alliance. Textile Alliance, whose sales cur- rently are about $160 million a year, markets textile products and also is engaged in dyeing and fin- ishing, weaving and knitting, and garment production. It's now bent on integrating backward into fiber production as well. Asahi owns 60% of Asahi Spin- ning (Ireland), Ltd., the second Irish venture, with Textile Alliance and C. Itoh & Co., a Japanese trad- ing firm, owning 15% each. The re- maining 10% in both Irish firms is held by the Irish government's In- dustrial Development Authority. Dumping okay called dangerous precedent Russell W. Peterson, chairman of the White House Council on Envi- ronmental Quality, has blasted the U.S. Eighth Circuit Court's deci- sion to allow Reserve Mining Co. to continue dumping 67,000 tons a day of taconite tailings, which con- tain asbestos fibers, into Lake Su- perior. He warns that if the lan- guage of the opinion is allowed to stand, virtually the only way the Government could prove a case in- volving health hazards is by "counting dead bodies through an after-the-fact epidemiology study." In a letter to Wallace H. John- son, an assistant attorney general in the Justice Department s land and natural resources division, Mr. Peterson further alleges that the court "in essence abandoned the traditional legal test applicable in a civil case, i.e., more probable than Peterson: unreasonable to expect proof not, and has imposed a test requir- ing scientific certainty." In its ruling the court said that "plaintiffs have failed to prove that a demonstrable health hazard ex- ists." The court added that "given the current state of medical and scientific knowledge, plaintiffs' case is based only on medical hypothesis and is simply beyond proof.' In Mr. Peterson's view it is un- reasonable to expect such proof, especially for cancer, since the full causes of the disease remain un- known "after the most intensive re- search campaign in medical histo- ry." Also, the court's approach to a possible health hazard is entirely wrong in Mr. Peterson's view. He says that lack of knowledge about a potential hazard should not be mis- read as proof that the hazard is slight or does not exist, and points out that "because of the latent ef- fects of carcinogens it will be more than 10 years before the magnitude of the health risk to the people of Duluth and Silver Bay will be fully realized, and unfortunately it will be based upon the fate of over 200,000 people." Artificial sweetener gets FDA approval With one artificial sweetener off the market for five years and another under scrutiny by the Food and Drug Administration, a new entry into the sweetener market has just been approved by FDA. The sweetener, aspartame, a product of G. D. Searle & Co., is about 180 times as sweet as sugar. And although the caloric value of aspartame is similar to that of sug- ars and proteins, the caloric intake of consumers using the product will be greatly reduced, since much smaller amounts are needed to pro- duce the same sweetening effect. Aspartame is, in fact, the conden- sation product of two amino acids, aspartic acid and phenylalanine. To be sold under the trademark Equa, the sweetener's chemical name is L-aspartyl-L-phenylalanine methyl ester, and it is claimed not to produce the bitter aftertaste as- sociated with other artificial sweet- eners. Searle predicts that the indi- vidual daily consumption of 0.8 gram of aspartame will provide about 5% of the normal daily in- take of aspartic acid and about 10% of that of phenylalanine. Aspartame is metabolized into its individual components in humans, and here some concern arises. FDA is requiring labeling of the com- pound to warn persons afflicted with phenylketonuria (PKU)—an inborn metabolic defect character- ized by intolerance for normal lev- els of phenylalanine—to avoid the product. However, Dr. Frank L. Lyman, of White Plains, N.Y., a physician and author of a book on the disease, says that because of di- etary requirements, PKU sufferers "would never use a product like this [artificial sweetener] in the first place." The new sweetener will be filling the void, partially at least, created by FDA's removal of cyclamates from the market in 1969. At that time cyclamates were suspected of being carcinogens, but new studies in the U.S. and overseas seem to disprove this, and Abbott Labora- tories, the leading producer, filed a new food additive petition with FDA in November 1973. But this review is moving slowly and proba- bly will drag on into 1975 (C&EN, Feb. 25, page 8). Meanwhile, sac- charin is also suspect as a carcino- gen, and FDA and the National Academy of Sciences currently are reviewing safety data on the widely used artificial sweetener to deter- mine its fate. August 5, 1974 C&EN 5

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Page 1: Artificial sweetener gets FDA approval

Japanese plan first European fiber plant Japan's first move into synthetic fiber making in Europe has come in Ireland's County Mayo. Asahi Chemical Industries is the leading shareholder in two joint ventures to produce acrylic fiber and yarn at Ballina. Hong Kong's Textile Alli­ance, Ltd., is Asahi's major part­ner.

With approvals by both the Jap­anese and Irish governments in hand and a site purchased, one venture will put an 18,000 metric-ton-per-year fiber unit on stream about June 1976. The other will bring an adjacent spinning plant capable of making 2500 tons a year of acrylic yarn into operation at the same time.

Technology will come from Asahi Chemical, Japan's number one acrylic fiber maker. At home, the company produces all three major synthetic fibers, but acrylic is its largest profit maker. Asahi has sold equipment and technology abroad in the past, but has been slower to invest overseas than have such other leading Japanese fiber firms as Teijin and Toray Industries. Last year, however, it set up Asahi Chemical International as a subsid­iary to evaluate and organize for­eign ventures.

The company holds a 45% inter­est in Asahi Synthetic Fibres (Ire­land); Textile Alliance owns 35% and Japan's Toray Industries 10%. Toray's interest stems from its po­sition as the main shareholder (about 30%) in Textile Alliance.

Textile Alliance, whose sales cur­rently are about $160 million a year, markets textile products and also is engaged in dyeing and fin­ishing, weaving and knitting, and garment production. It's now bent on integrating backward into fiber production as well.

Asahi owns 60% of Asahi Spin­ning (Ireland), Ltd., the second Irish venture, with Textile Alliance and C. Itoh & Co., a Japanese trad­ing firm, owning 15% each. The re­maining 10% in both Irish firms is held by the Irish government's In­dustrial Development Authority.

Dumping okay called dangerous precedent Russell W. Peterson, chairman of the White House Council on Envi­ronmental Quality, has blasted the U.S. Eighth Circuit Court's deci­sion to allow Reserve Mining Co. to

continue dumping 67,000 tons a day of taconite tailings, which con­tain asbestos fibers, into Lake Su­perior. He warns that if the lan­guage of the opinion is allowed to stand, virtually the only way the Government could prove a case in­volving health hazards is by "counting dead bodies through an after-the-fact epidemiology study."

In a letter to Wallace H. John­son, an assistant attorney general in the Justice Department s land and natural resources division, Mr. Peterson further alleges that the court "in essence abandoned the traditional legal test applicable in a civil case, i.e., more probable than

Peterson: unreasonable to expect proof

not, and has imposed a test requir­ing scientific certainty."

In its ruling the court said that "plaintiffs have failed to prove that a demonstrable health hazard ex­ists." The court added that "given the current state of medical and scientific knowledge, plaintiffs' case is based only on medical hypothesis and is simply beyond proof.'

In Mr. Peterson's view it is un­reasonable to expect such proof, especially for cancer, since the full causes of the disease remain un­known "after the most intensive re­search campaign in medical histo­ry." Also, the court's approach to a possible health hazard is entirely wrong in Mr. Peterson's view. He says that lack of knowledge about a potential hazard should not be mis­read as proof that the hazard is slight or does not exist, and points out that "because of the latent ef­fects of carcinogens it will be more than 10 years before the magnitude of the health risk to the people of Duluth and Silver Bay will be fully realized, and unfortunately it will be based upon the fate of over 200,000 people."

Artificial sweetener gets FDA approval With one artificial sweetener off the market for five years and another under scrutiny by the Food and Drug Administration, a new entry into the sweetener market has just been approved by FDA.

The sweetener, aspartame, a product of G. D. Searle & Co., is about 180 times as sweet as sugar. And although the caloric value of aspartame is similar to that of sug­ars and proteins, the caloric intake of consumers using the product will be greatly reduced, since much smaller amounts are needed to pro­duce the same sweetening effect. Aspartame is, in fact, the conden­sation product of two amino acids, aspartic acid and phenylalanine.

To be sold under the trademark Equa, the sweetener's chemical name is L-aspartyl-L-phenylalanine methyl ester, and it is claimed not to produce the bitter aftertaste as­sociated with other artificial sweet­eners. Searle predicts that the indi­vidual daily consumption of 0.8 gram of aspartame will provide about 5% of the normal daily in­take of aspartic acid and about 10% of that of phenylalanine.

Aspartame is metabolized into its individual components in humans, and here some concern arises. FDA is requiring labeling of the com­pound to warn persons afflicted with phenylketonuria (PKU)—an inborn metabolic defect character­ized by intolerance for normal lev­els of phenylalanine—to avoid the product. However, Dr. Frank L. Lyman, of White Plains, N.Y., a physician and author of a book on the disease, says that because of di­etary requirements, PKU sufferers "would never use a product like this [artificial sweetener] in the first place."

The new sweetener will be filling the void, partially at least, created by FDA's removal of cyclamates from the market in 1969. At that time cyclamates were suspected of being carcinogens, but new studies in the U.S. and overseas seem to disprove this, and Abbott Labora­tories, the leading producer, filed a new food additive petition with FDA in November 1973. But this review is moving slowly and proba­bly will drag on into 1975 (C&EN, Feb. 25, page 8). Meanwhile, sac­charin is also suspect as a carcino­gen, and FDA and the National Academy of Sciences currently are reviewing safety data on the widely used artificial sweetener to deter­mine its fate.

August 5, 1974 C&EN 5