Supplement Labeling of "Per Day" Ingredient Amount Proposed by FDA

Dietary supplement makers would be permitted to voluntarily label products with the total "per day" quantitative amount of nutrients or other components the product supplies under an FDA proposed rule published in the Federal Register Jan. 12.

Labeling also could include the total daily percentage of the Recommended Daily Value a product supplies if taken as directed.

The proposed rule would allow the optional information to be carried by products labeled for use more than once a day. The proposal also includes a sample label incorporating the "per day" column.

Comments on the proposed rule are due March 29, 1999. Comments on the proposed collection of information are due Feb. 11, 1999.

The proposal responds to a citizen petition requesting the change filed with the agency in January 1998 by the Nutrilite division of Amway ("The Tan Sheet" Feb. 2, 1998, p. 16). The company argued the change would be "reasonable" and provide for greater safety in supplement usage.

Under FDA's September 1997 and January 1994 final rules on dietary supplement labeling, manufacturers are required to label supplement products with the amount of nutrients or other substances supplied per "serving" of a supplement ("The Tan Sheet' Sept. 29, 1997, pp. 1-7).

The 1997 rule also permits voluntary labeling of the amount provided per unit (e.g., tablet, teaspoon, scoop) if more than one unit is taken in a serving. Under the current proposed rule, manufacturers would be permitted to use either the "per unit" or the "per day" optional columns, but not both on a product label.

FDA is "persuaded by the petitioner that this additional information may be useful to impress upon consumers of dietary supplement products the total daily intake of each dietary ingredient they will receive from a product that is recommended for consumption multiple times per day," the proposed rule states.

The agency notes many dietary supplement companies are in the process of changing labels to comply with the September 1997 final rule, which becomes effective March 23.

The agency "does not expect to complete this rulemaking in time for the 'per day' information to be incorporated as part of the current changes," the proposal states.

The "proposed 'per day' information would not be misleading," however, and the agency "does not intend to object to manufacturers declaring information on a 'per day' basis prior to issuance of a final rule," if it is "consistent with this proposal."

Manufacturers "should be aware that a final rule on this issue may differ from this proposal," FDA adds.

Regarding the economic impact of the rule, the agency says the proposal "provides manufacturers of dietary supplements flexibility to voluntarily present additional label information to consumers. This rule will result in costs and benefits only to the extent that firms elect to take advantage of the option of presenting information on a 'per day' basis."

"No firm will bear the cost of redesigning labels unless it believes that the claim will result in increased sales of its product," the document states.

Nutrilite told the agency about 10 of its products bear instructions for use more than once a day, and the company likely would use the optional "per day" information on almost all of them, an FDA memo of a telephone conversation with the firm states.

The company also told the agency there would be no cost associated with incorporating the change if it could be made along with the other changes required by the March 23 supplement label rule's effective date.

In a similar conversation, Pharmavite told FDA it probably would use the "per day" column on about 40, or 10%, of its products - all of which bear directions for use more than once a day.

Leiner told the agency it would probably include "per day" data on 10%, or about 45, of its products. All three companies estimated about 10% of the dietary supplement industry as a whole would use the optional label column.