THE COLOR ADDITIVE AMENDMENTS OF 1960

IV. THE COLOR ADDITIVE AMENDMENTS OF 1960

Regulation of color additives has a longer history in the United States than regulation of any food additive other than preservatives. These two food substances were the subject of special legislation enacted by Congress in the Color and Preservatives Act of 1900 (93), requiring FDA to investigate their safety even before there was federal legislation authorizing national regulation. Under the 1906 Act, separate provisions were enacted that FDA interpreted to authorize greater control over food colors than any other form of additive (94), even though that authority was on very uncertain legal ground. The 1938 Act explicitly provided for FDA listing of coal tar colors, which are harmless and suitable for use in food and for the batch certification of these colors, the only form of premarket approval for food substances prior to 1958 (95).

Just two years after enactment of the Food Additives Amendment, prompted by a Supreme Court decision interpreting the FD&C Act to require absolute safety for any color additive (96), Congress enacted a new statute to require premarket approval of color additives (97). It established a system similar to that for food additives, but it was different in one critical respect.

The 1960 Amendments, unlike the 1958 Amendment, did not contain a general exclusion for GRAS substances. Instead, it excluded only those GRAS substances that were listed on a formal published FDA GRAS list under the 1958 Amendment (98). As

a practical matter, this exclusion has meant nothing. As will be discussed further, this difference accounts for a large part of the failure of the 1960 Amendments. It has meant that every color additive, of any kind, must be the subject of a color additive regulation before it may lawfully be used.

A. The Transitional Provisions A. The Transitional Provisions

Like the Food Additives Amendment, the Color Additive Amendments included transitional provisions (102). The 1960 Amendments provided for provisional listing of pre-1960 color additives ‘‘on an interim basis for a reasonable period’’ pending the com- pletion of scientific testing that would allow permanent listing under color additive regula- tions.

The Color Additive Amendments were enacted into law on July 12, 1960. The statute provided a two-and-one-half year transitional period for this testing and promulgation of color additive regulations, but then went on to state that FDA could establish a longer transitional period, without limitation. As the years went by, and FDA testing requirements escalated, the transitional period was repeatedly extended by FDA. In the late 1970s, FDA imposed additional new testing requirements for carcinogenicity, thus forcing a major extension of the time needed to complete testing and to promulgate color additive regula- tions (103).

The resulting delay provoked litigation that began in the mid-1970s and continued for the next 10 years. In each of these cases, the courts found that the continued provisional listing was lawful under the statute (104).

Today, 40 years after the law was enacted, the transitional provisions are still not yet fully implemented. The FD&C lakes remain provisionally listed (105) and thus have not yet been subject to final FDA action.

There are only two potential explanations for the difference between the remarkably swift and efficient handling of the food additive transitional provisions and the extraordi- narily inefficient bungling of the color additive transitional provisions. Both were handled by the same group of people within FDA. First, for food additives, there was a statutory deadline with a ‘‘hammer’’ that required definitive FDA action. A food additive that missed the deadline became illegal by operation of law. For color additives, in contrast, there was no statutory deadline and no definitive action required. Second, the food additive decisions were required to be made during an era when FDA was accustomed to making prompt decisions and taking decisive action, before the current paralysis began to set in. By the time that the transitional color additives were ripe for action, the agency’s capacity to make decisions had already deteriorated badly.

B. The Lack of a GRAS Exclusion

For a new food substances, the GRAS exclusion has turned out to be the single most important statutory provision. The food additive provisions are basically a dead letter at this point in time. Unless reformed, they will only rarely be used in the future. For color additives, unfortunately, there was only a very limited GRAS exclusion, which has had no impact. The color additive GRAS exclusion explicitly requires that to be exempt from the requirement for a color additive regulation, the coloring substance must be included on a published FDA GRAS list. No such list exists. As a result, all substances intended to color food must be the subject of a color additive regulation.

The lack of a GRAS exclusion under the Color Additive Amendments has put color additives at a distinct disadvantage to food additives. Nor is there any rational scientific or public policy basis for this difference.

the time of industry or FDA on color additive regulations for such ordinary substances as beet powder, grape extract, fruit juice, vegetable juice, carrot oil, and paprika (106). The mere existence of the requirement for a color additive petition and regulation for simple compounds like these unnecessarily clogs the regulatory process and stifles product innovation.

C. Implementation of the Color Additive Amendments

The record of color additive technology in the United States in the past 40 years under FDA administration of the Color Additive Amendments is atrocious. Only one new coal tar color additive—FD&C Red No. 40 (107)—has been approved during this time for broad food use. As a practical matter, color additive technology for use in food products in the United States today is not just moribund, it is completely dead.

One new company made a valiant effort to enter this market, during the mid-1970s: the Dynapol Corporation. Recognizing that FDA was beginning to disapprove important food color additives, the company sought a new approach. Focusing on FD&C Yellow Nos. 5 and 6 and on FD&C Red No. 2, the company initially made three polymeric food additives by chemically attaching the colors to nonabsorbable polymer molecules, thus in theory reducing toxicity because they would pass through the gut without being absorbed and metabolized. Five years later this effort came to an abrupt end when, in a rat bioassay, one of these compounds proved to be tumorigenic (108). The company concluded that it would not be feasible to obtain a color additive regulation with these results under the Delaney Clause even if human safety could be shown and thus went out of business.

It is easy to argue that color additives are not a major health priority, and thus that the total destruction of new technology in color additives is not of major concern. The fact remains, however, that color additives are exceedingly important to the entire food and drug supply. Color is essential to the palatability of food products. Drugs are frequently distinguished by their coloring as well as their shape. The entire purpose of many cosmet- ics is to impart color to the skin. A number of medical devices depend upon coloring as part of their utility and distinctiveness. It would be a drab world, indeed, if color did not exist.

D. The Lack of Market Protection

Unquestionably, the lack of any form of market protection for a new color additive has contributed greatly to the decline of this technology in the United States. The only new color additive approved in the past 40 years, FD&C Red No. 40, was the subject of a patent. It is inconceivable that any company would invest the millions of dollars and years of time necessary to obtain approval of a new color additive under the present law, which permits a competitor to market the identical product immediately, unless there is strong patent protection or the law is changed to provide a substantial period of market exclusiv- ity. Like food additives, color additives were granted patent term restoration in 1984 but not market exclusivity (109).