Harold Salwin, Division of Food Technology, Protein and Cereal Products Branch. (HFF-416). Howard Pippin, Division of Regulatory Guidance, Guidelines and Compliance Research Branch (HFF-312). F. Leo Kauffman, Ph.D., Assistant Director, Division of Food Technology (HFF-413) Prince Harrill, Ph.D., Deputy Director, Division of Food Technology (HFF-411). Lou Brock, Regulation Coordination Staff (HFF-302). Subject: Meeting with Representatives of the American Bakers Association Concerning Status of ABA petitions and other matters of interest to ABA pending before FDA. 1. The visitors asked about the status of the Confirmation of Effective date notice for Part 17-Standards of Identity for Bakery Products. Mr. Quinn informed the vistors that we expect a notice to be published in the Federal Register in the very near future. 2. The visitors asked about the status of its petition to shorten common or usual names for certain ingredients used by bakers. Mr. Quinn told the visitors that we would expedite their petition as soon as possible. Mr. Quinn did point out that it has been FDA's policy in the past to require that the complete scientific names, with or without the shortened name in parentheses, appear on the label. 3. The visitors asked whether their comments on the Bakery GMP proposal had been helpful. Dr. F. Lee Kauffman told them that they were. 4. The visitors indicated that they were developing a labeling manual and wanted to leave us a copy of the draft section on incidental additives to get our informal suggestions. Mr. Quinn advised the visitors that they should submit the draft formally. LIST OF AGENCY CONTACTS WITH INDUSTRY IN REGARDS TO FOOD INGREDIENT REGULATIONS OF JANUARY 1, 1976 MEMORANDUM OF MEETING Between Bob Lake, Acting Regulation Staff Coordinator (HFF-302) Bureau of Foods and William G. Botty, President, Robert N. Pyle, Executive Director, Independent Bakers Association, Suite 450, 1707 L Street, N.W., Washington, D.C. 20036. Subject: Status of the American Bakers Association Petition of January 10, 1977 concerning the Labeling of Bakery Products. In April 1977, Mr. Botty and Mr. Pyle stopped by my office and introduced themselves as representatives of the Independent Bakers Association. They apologized for coming in unannounced, but stated that they were interested in knowing whether the American Bakers Association had recently submitted a petition concerning the labeling of bakery products. They also wanted to know what the petition might contain. Initially, I did not recall having seen that petition, so I asked whether they had any idea as to when it might have been submitted to the Agency, and whether they could give me any specific information about the nature of the petition. They advised that they were uncertain as to when the petition might have been submitted and indicated that they had not seen it. However, they understood that a ptention was to be submitted by the American Bakers Association asking for revision of some provisions in the FDA ingredient labeling regulations that were published on January 6, 1976 (there are now found in 21 CFR 101.4). They went on to indicate that they were concerned about the matter for two reasons; first, the economic impact of the January 6, 1976 regulation was considered by them to be serious for small bakers, and second, they were concerned that the American Bakers Association might not be adequately representing small independent bakers. I asked them to wait a bit while I checked the files. I found that a petition had been submitted by the American Bakers Association on January 10, 1977 (FDA Docket No. 77P-0017). I also noted that the petition had been forwarded to the Guidelines and Compliance Research Branch (HFF-312) for preparation of a response. I showed a copy of that petition to Mr. Botty and Mr. Pyle. They asked for a copy for themselves, so I had a copy made for them. They then asked when the petition would be acted upon. I told them that I was unable to specifically answer that question, but pointed out that we had a number of petitions to consider, including some that were submitted before the American Bakers Association petition. I went on to say, however, that the petition was being evaluated, and that the Agency would respond to it as soon as it could. I also suggested to them that they could file a petition on behalf of the Independent Bakers Association if they had special concerns. I went on to state that if they submitted a properly supported petition, it would be given full consideration by the Agency. Before they left, Mr. Botty and Mr. Pyle asked what the basis for the January 6, 1976 regulation was. I pointed out to them that Section 403 of the Federal Food, Drug, and Cosmetic Act provided for ingredient declaration for all ingredients except spices, flavorings, colorings, and mandatory ingredients in products covered by standards of identity. BOB LAKE. DPARTMENT OF HEALTH, EDUCATION, AND WELFARE-MEMORANDUM OF TELEPHONE CONVERSATION AND VISIT, JULY 29, 1977 In April 1977, Mr. William Botty of the Independent Bakers Association called me concerning the ingredient labeling regulation and its effect on small bakers. He demanded that I see him right away. I told him that I was tied up with important matters right now but that I would make an appointment within the next couple of days. Mr. Botty became abusive saying that he was a taxpayer and I was a servant of the people and that unless I saw him immediately he would contact his senator and/or congressman, etc. I told him that there was nothing I could do for him but I would see him. After a while he came in with Mr. Robert N. Pyle, also of the Independent Bakers Association. I told him that I had no authority to amend regulations and I explained how a petition could be submitted. He finally calmed down somewhat after I explained the petition method and told him how and who handled petitions in the Bureau. RAYMOND E. NEWBERRY. BUREAU OF FOODS, DIVISION OF REGULATORY GUIDANCE, Mr. ROBERT N. PYLE, Independent Bakers Association, Washington, D.C. DEAR MR. PYLE: This replies to your letter of April 15, 1977 to Commissioner Kennedy concerning the labeling of bakery products. Apparently, both you and your member, Mr. Derst, have been misinformed. We have replied to several congressional inquiries concerning Mr. Derst's confusion. First of all the fat declaration regulation (indicated by § 1.10(b) (14) of the enclosure) permits alternative methods of declaring fats and oils [e.g. "Vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil")]. Secondly, it has never been permissible to use alternative sweeteners (e.g. dextrose, corn sugar, cane sugar, etc.) without specific label identification of the sweetener used. We are enclosing a copy of the regulations involved and refer you to $1.10b on page 1166. This points out that interested persons may submit petitions to specify the manner in which ingredients shall be declared (i.e. by specific or class name, or $1.10a to exempt an ingredients (s) from the requirements for label declaration). Sincerely yours, R. E. NEWBERRY, Assistant to the Director. Present: MEMORANDUM OF MEETING, MAY 25, 1978 Howard Bauman, Vice President of Science and Technology, Pillsbury College. Kurt Stern, Executive Vice President, The DCA Company. Robert R. Kimmel, Associate General Counsel and Assistant Secretary, International Multifoods Corporation. Joseph P. Hile, Associate Commissioner for Compliance, FDA. Howard R. Roberts, Acting Director, Bureau of Foods, FDA. Subject: Ingredient Labeling. The visitors indicated that they were concerned about ingredient labeling in situations where a component of a finished food was itself composed of several ingredients. They stated that there was some confusion in the industry as to the interpretation of section 1.10(b) (2) In such situations. Their position was that components having a common or unsual name established by usage could be treated by the alternative labeling procedure of section 1.10 rather than the "integrated" procedure (i.e., listing in parentheses following the name of the component its ingredients in descending order of predominance rather than listing each individual ingredient by order of predoimnance in the finished food.) They noted that there was a widely held view in industry that essentially all bakery products will have to bear integrated ingredients labels to comply with section 1.10. They next pointed out that the rigid requirement for integrated labeling would not necessarily be informative to consumers (e.g., a "valuable" ingredient such as egg could be too far down on the list to be noticed), it would likely divulge trade secrets (component suppliers would have to tell customers the exact component formula), it would lead to restraint of trade (the tendency would be to use a single supplier to avoid label change) and would impede research (again to avoid label change). We suggested to the visitors that in light of their concern and the apparent industry confusion they should submit a written request for an advisory opinion. They indicated that they would do so. We promised to respond to their request as expeditiously as priorities would permit. HOWARD R. ROBERTS, Ph. D. COST OF WORK ON THE JANUARY 6, 1976 REGULATIONS REGARDING FOOD LABELING AND LABEL DECLARATION OF INGREDIENT REQUIREMENTS The total cost of work on these regulations to date is approximately $37,000. There were no travel expenses or consultant fees involved in the promulgation of these regulations. Mr. SKELTON. Proceed, please. Dr. ROBERTS. However, we can safely say that over the years we have received literally hundreds of complaints and comments from consumers who want ingredient labeling not only for bakery, but indeed for all food products. Ingredient labeling: Let me next explore further, for the moment, the subject of consumer interest in labeling. The most obvious point in this regard is that the laws passed by the Congress-acting as representatives of the consumers-require basic ingredient labeling of foods. Then going back a few years, one of the major themes of the 1969 White House Conference on Food, Nutrition and Health was the need to provide additional information about the composition of foods to the public. The consumer Task Force of the Conference, specifically called for full informative labeling of all foods being opposed in general in any exemptions. Especially since about 1970, consumers, in increasing numbers, have been telling the Agency that they not only want all ingredients listed on the label, but they would like to have the percent of each ingredient shown also. Currently, for most foods, FDA does not require percentage declarations of ingredients. In May of 1971, five George Washington University law students, calling themselves LABEL-Law Students Association Buyers' Ed ucation and Labeling-petitioned the FDA to make total ingredient labeling mandatory for standardized foods. The proposal attracted 4,000 comments from consumers, consumer groups, the medical and scientific community, State and local governments, and the food industry. Most of the comments favored the proposal, even though FDA is precluded by the act from requiring such labeling for mandatory ingredients. While FDA concluded that it did not have the authority to require label declarations of mandatory ingredients in standardized foods, the Agency has encouraged such declarations. This consumer concern has steadily increased with concern over the multiple ingredients in processed foods, and there has been a corresponding demand that those ingredients be completely disclosed. We received numerous comments expressing this desire in response to our June 14, 1974 proposal regarding a uniform method of declaring the percentage of ingredients in foods. The main theme throughout the consumer responses to that proposal was that they not only wanted full ingredient labeling, but that they wanted percent ingredient labeling as well. To further illustrate this point, I would like to submit for the record a summary of 1975, 1976, and 1977 consumer surveys conducted by FDA and the U.S. Department of Agriculture on food ingredient labeling which show increasing consumer interest in more informative food labeling. Mr. Chairman, consumers today want to know in specific detail what they are eating. [The summary referred to above follows:] A SUMMARY OF CONSUMER SURVEYS ON FOOD INGREDIENT LABELING FOR 1975 (FDA), 1976 (USDA), AND 1977 (USDA) In the summer of 1975 a national area probability sample of 1,664 U.S. adults who did at least one half of the food shopping for the household were interviewed face-to-face in the households. Of these, a subsample of 514 respondents were asked questions of about expectations from food labels. 1. Forty-five percent said they almost always or usually read ingredients on labels carefully. 2. Shoppers were asked about the situation where a breakfast cereal contains a lot of sugar but is not sugar coated. The label does not point out sugar conttent except in the list of ingredients. Shoppers might not realize the cereal actually contains a lot of sugar. The majority (62 percent) said that as far as they knew this hasn't happened but thought it could happen to them. When asked whether something should have been done about it or not, 66 percent said something should be done. The inference is that consumers want it made clear how much sugar is in the product which suggests the need for more information on ingredients. When the total sample of 1,664 U.S. adult food shoppers were asked if they checked the list of ingredients on any of the cans or packages before they bought something or not, about 46 percent, almost half, said they had. About 32 percent said "no" but that they had checked the list of ingredients on cans or packages in the past. Combined, these totals to about 78 percent of the U.S. population reporting they have used ingredient labeling. The U.S.D.A. survey shows the importance of ingredient labeling to consumers and that consumers are paying more attention to it. The U.S.D.A. survey was also a nationally, representative sample with approximately 1,400 shoppers and from approximately the same universe selected and in cooperation with FDA. It showed that in the spring of 1976, 65 percent of the shoppers found ingredient labeling extremely or very useful and 67 percent gave this response in 1977. In 1976, about half the shoppers said they al ways or almost always read the ingredients listed on the label the first time they bought a product and in 1977 the proportion of this response rose to 66 percent. Dr. ROBERTS. In February, 1975, FDA received a petition from the Center for Science in the Public Interest calling for the percentage labeling of ingredients in infant and junior foods. In September 1976, FDA published a proposal for percentage ingredient labeling of infant and junior foods in part based on this petition. Again, the comments received in response to this proposal were overwhelming in support of increased label information. In a national survey conducted by Louis Harris and reported earlier this year, 85 percent of the consumer respondents voiced concern ranging from a little bit to a great deal about misleading packaging and labeling. Respondents in this same survey ranked food manufacturers first among those industries that they felt should receive most attention from the consumer movement. The foregoing are but some brief examples of consumer interest. Our experience with responses to many of our proposed regulations indicates a high level of consumer interest not only in label declaration of the identity of all ingredients but in the declaration of the percentage of each ingredient present in food. I might just add a footnote here. Two members of this subcommittee have in the past cosponsored legislation for full ingredient labeling along with the percentage labeling of each ingredient. Mr. SKELTON [presiding]. May I ask you, sir, would you suspend for just a couple of minutes. The chairman will be back momentarily, and in order for me to make the vote, I better leave now. Dr. ROBERTS. Fine. [Brief recess.] Dr. ROBERTS. Let me now get back to the subject regulations. FDA proposed on June 14, 1974, regulations revoking the previously mentioned TC-94 and including various provisions for the label declaration of ingredients. On January 6, 1976, we published final regulations on those parts of the proposal governing the way in which certain food ingredients may be declared on the label-21 CFR 101.4-as well as other parts not of immediate interest. Recognizing a need for sufficient lead time. to prepare the new labels, 2 years were allowed for the necessary changes; the effective date for compliance with the new regulation is January 1, 1978. I would like to submit for the record a copy of this regulation. Mr. Russo. Without objection, so ordered. [The document referred to follows:] F.D. & C. ACT TRADE CORRESPONDENCE Bakery Products (435); Bread (435.2); Declaration of shortening (451.11); leavening ingredients (485); and “yeast nutrient,” (“dough conditioner") (494). "In the case of shortening and leavening, we have taken the position that where particular shortening or leavening ingredients that may be used at any given time by a manufacturer cannot always be predicted in advance, we would not object to declaring such ingredients by the term 'shortening' or 'leavening', as the case may be, in lieu of naming each specific substance. This is on the understanding that if it develops that the practice results in denying the consumer |