Inspections, Compliance, Enforcement, and Criminal Investigations
CPG Sec. 120.500 Health Fraud - Factors in Considering Regulatory Action
Health Fraud products are articles of unproven effectiveness that are promoted to improve health, well being, or appearance. They can be drugs, devices, foods or cosmetics for human or animal use.
The previous CPG 7150.10 (See Sec. 120.500), Quackery - Priorities for Initiating Legal Action, established agency priorities based on categorizing the violative articles as a "direct health hazard", "indirect health hazard", or "major economic cheat". While such descriptions served the purpose of communicating the general impact of different types of health fraud products on the public, they did not take into account a number of factors which influence the initiation of a regulatory action.
This revision of the CPG establishes practical definitions for "direct health hazard", and "indirect health hazard". Because all health fraud products are in fact economic cheats, a separate definition for major economic cheat has been eliminated. The revised CPG also describes factors the agency will consider prior to initiating regulatory actions against health fraud products.
*HEALTH FRAUD: The deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate, or done without adequate knowledge or understanding of the article.*
A health fraud product presents a direct health hazard if it is likely to cause injury, death or other serious adverse effect when used as directed or in a customary manner.
A health fraud product presents an indirect health hazard if, as a result of reliance on the product, the consumer is likely to delay or discontinue appropriate medical treatment. The health hazard is indirect when it does no direct harm to the person as a result of its use, but rather denies, delays, or interferes with effective treatment. Consumers who purchase these products are misled by exaggerated or false claims that are made for the products.
Products that pose a direct health hazard to the user shall receive the agency's highest priority attention, regardless of whether they are health fraud products. Documented cases of such products should be expedited and referred to the appropriate center for regulatory follow-up. Health fraud products for which there is not a documented direct health hazard (i.e. indirect health hazard products) will still be considered for regulatory action but on a lower priority.
In evaluating regulatory actions against indirect health hazard products, the following factors should be considered by districts and the centers:
1. Whether the therapeutic claims or conditions to be treated are significant as interpreted by the appropriate center;
2. Whether there are scientific data or specific information to support the safety or effectiveness of the product for its intended or customary use;
3. The degree of vulnerability of the prospective user group, e.g., the elderly, persons with illnesses for which there is no recognized effective treatment;
4. The availability of other administrative or regulatory alternatives to bring the product or firm into compliance, e.g., education, referral or cooperation with local, state or other federal agencies;
5. The amount of agency resources required and whether they are sufficient to pursue the action to its conclusion;
6. The source of the product, size of the industry distributing the same or similar products, and the impact of the action on that source and industry;
7. The cost of the product, the economic impact of this case on the target user group, as well as the profit (per sale) realized from the sale of the product;
8. The amount (dollar and volume) of product sold, and the geographical scope of its distribution;
In most cases, the seriousness of the therapeutic claims and the nature of the indirect hazard will be obvious. We recognize that when a product with unproven therapeutic claims is first introduced, it is difficult to predict its economic impact because, whether or not a regulatory action is taken, the product may not be accepted in the marketplace. Generally, new health fraud products with undetermined economic impact and limited health significance should result in a *Warning* Letter to the promoter. *Further* regulatory action should be considered for products ** when it appears there is a growing national or substantial regional market for them. The office of compliance in each center will designate a contact and a back-up person for primary consultation on health fraud action.
Foods for human use, nutritional supplements and cosmetics with therapeutic claims will generally be treated as drugs and should be referred to the *CBER or CDER*, Health Fraud Staff, which will coordinate these issues with the Center for Food Safety and Applied Nutrition.
Health fraud products that are the statutory responsibility of another agency should generally be referred to that agency for follow-up. For example, a strictly mail order operation, or one which principally uses media advertising should be referred to the U.S. Postal Service or the Federal Trade Commission and assistance provided, as needed. Local and state health departments and other federal agencies should be consulted because they may be sources of possible corrective action. If the health fraud practice or operation has been legalized (or its practical equivalent) in a certain locality, it is unlikely that a referral for a regulatory action against that practice or operation would be approved in that locality unless there are compelling reasons to do so. This does not preclude action in other jurisdictions. Referral of information on fraudulent products to the appropriate home district and headquarters units should be done as a matter of course.
In general, regulatory action will continue to be deferred on products that are covered by the OTC Review, pending the publication of final monographs.
*Material between asterisks is new or revised*
Revised: 6/5/87, 3/95