7 between diet and health. It is precisely because public health issues are involved that the free flow of truthful information is critical. APPENDIX 2.-CORRESPONDENCE AND RELATED DOCUMENTS Submisssion for the Record FDA's New Proposal to Permit Disease-Specific Health Claims on Food Products Thursday, December 10, 1987 House of Representatives SUBMISSION: Chairman Weiss states that the record will remain open so that any one wishing to submit further testimony may. Mr. Paul J. Sage of the Food and Drug Administration is submitting a copy of the key points that he preparted for this hearing. (467) Weiss' offer to receive ten day I would like to take advantage of Mr. Paul Sage Key points re: Health Claims In Foods FDA's new policy of permitting health and disease claims in food labeling a policy which, quite surprisingly, was adopted simultaneously with its being proposed represents a complete break with tradition. I believe, and other knowledgable authorities on quackery believe, that it will usher in a new wave of nutritional quackery, a major public health problem that is not at all well-regulated today. the marketplace and confusion among consumers. all of the policy's adverse ramifications. There will be chaos in It is hard to parse out The policy is, to a considerable extent, contrary to law because it ignores important definitions and requirements of the Food, Drug, and Cosmetic Act, so as to contravene its intent. For example, foods that are promoted with disease claims are drugs within the meaning of the statute and the policy waives important requirements that drugs must meet. These requirements include preclearance of claims on the basis of substantial evidence, adequate directions for use, and registration and drug listing requirements which make it possible for FDA to identify sponsors and find products that are promoted for use in the prevention, treatment, mitigation, or cure of disease. For the most part, FDA does not have authority to waive these requirements and it would not be in the public interest to waive them. Moreover, the policy is unfair to drug manufacturers because it exempts food manufacturers from meeting statutory requirements that drug manufacturers can, must, and do regularly meet. Even in applications where it might not be contrary to law the policy is vastly overbroad. any It is overbroad because anyone would be permitted to develop and put health or disease claims to use without notifying FDA or obtaining approval from the agency. In the absence of drug registration and listing requirements, FDA will not be able to find health claims promptly, much less review them in a timely manner. This is important because, once launched, deceptive health claims acquire a life of their own and they are very difficult to extinguish. Moreover, to be effective, FDA's regulatory response must be swift and sure. The proposal is overbroad because it would permit any kind of food to bear health claims, even when possible benefits are outweighed by adverse health effects. The Campbell Soup Company is already promoting the fiber in its "Salt 'N Vinegar" potato chips are high in fat, low in fiber, and high in sodium. How are they labeled? - NO CHOLESTEROL! I submit that you ain't seen nothing yet. -2 The policy is also overbroad because it would permit any kind of will important messages will to make by If this is permitted, unimportant ones. try Witness the "No Cholesterol" potato chips. everything seem important for In addition to being over broad, unfair, and largely contrary to law, the policy is unnecessary. promoted for dual uses if they are safe and effective for food and drug, The statute permits products to be labeled and or drug and cosmetic purposes. unreasonable to expect that the regulated industry meet the requirements This is eminently reasonable. Is it of the statute or that FDA enforce them? I should hope that it is not. Today, misinformation about health is rampant and health fraud is not well-regulated. FDA's new policy is of doubtful legality; it introduces a new ambiguity into the definition of products that clearly appear to be drugs, and it exempts food products a drug by with drug claims from compliance with drug labeling and preclearance treating as foods provisions of the law. it will require substantial resources to enforce. It will be impossible to effectively monitor and come too late, after the barn door is open and the damage caused by Most enforcement will misinformation is done. The damage will not be easy to correct. to In my opinion, it would be far better for FDA requirements which prohibit health claims in food labeling and put some of the resources saved to work prosecuting promoters of health fraud. In preserve existing any event, the interim enforcement policy which was adopted when this proposal was published should be rescinded and FDA should call for a moratorium on health claims in foods at the present time. |