The second surprise was the FDA suggestion that for liuid extrects, ingredients should be listed by weight, and with a ration of the weight of the starting material to the solvent, for example, "fresh dandelion root extract, x mg (y:z) in 70% ethanol." This provision(2) affects liquid extracts from which all the liquid has not been removed, including tinctures. This provision reads as follows:
(B) For any dietary ingredient that is a liquid extract from which the solvent has not been removed, the quantity listed shall be the weight of the total extract with information on the concentration of the dietary ingredient, the solvent used, and the condition of the starting material (i.e. whether it is fresh or dried), e.g., "fresh dandelion root extract, x mg (y:z) in 70% ethanol," where x is the number of mg of the entire extract, y is the weight of the starting material and z is the volume (milliliters) of solvent. Where the solvent has been partially removed (not to dryness), the final concentration shall be stated (e.g., if the original extract was 1:5 and 50 percent of the solvent was removed, then the final concentration shall be stated as 1:2.5).
The American Herbal Products Association (AHPA) has asked that this provision be reconsidered, and that after reconsideration, FDA should adopt technical amendments which AHPA has proposed.
FDA's December 1995 proposal on liquid extracts stated: "For any dietary ingredients that are liquid extracts, the weight shall not include the weight of solvents."(3) FDA requested and received comments on this particular formula. Because the final regulation differed substantially from the proposal, AHPA challenged its legality. However, AHPA appreciates that the agency's intention in promulgating the provision for liquid extracts may have been based on actual and perceived confusion in the labeling of products in the marketplace. AHPA also agreed better controls are needed in the manner in which certain information is quantified on some liquid extracts of botanicals. However, AHPA told FDA this can best be accomplished by establishing standard definitions and calculations for use in presenting meaningful quantification information, rather than by establishing a single form for a ratio statement as a requirement for all products. Indeed, AHPA's standards committee has been an d continues to work on definitions and guidelines for herbal extracts.
As an alternative to FDA's final regulation, AHPA proposed that FDA amend the regulations to read as follows:
(B) For any dietary ingredient that is a liquid extract from which the solvent has not been removed, the quantity listed shall not be the weight but shall instead be the volume of the total extract. If information is included on the concentration of the dietary ingredient in the form y:z, it shall be expressed as a ratio of the weight (in grams) of the starting material to the volume (in milliliters) of solvent. Additionally, the condition of the starting material shall be stated if the starting material is in fresh condition (e.g., "fresh dandelion root extract(y:z)"), and may be stated if the starting material is in dried condition. If a product contains a dietary ingredient that is a liquid extract from which the solvent has not been removed and is labeled in any manner which quantifies or claims to contain one or more specific contained constituents of a botanical, the constituent shall be quantified on the label by weight on a "per serving" basis, in accordance with paragra ph (b)(3)(iii) of this section.
There were several reasons for the AHPA proposals.
1. The quantity of a dietary supplement that is a liquid extract should be stated in volume, not in weight.
Weight measures, AHPA argued, are not meaningful to consumers of any food product in liquid form, and may, in fact, be confusing. The Dietary Supplement Health and Education Act of 1994 ("DSHEA") states that the quantity listing requirement for each dietary ingredient shall be complied with "in a manner which is appropriate for the product.(4). There is no requirement that all quantities be stated by weight. Labeling should use language which creates the least confusion among consumers. Any requirement to state a weight measure for a liquid product would simply confuse people.
2. Solvents that have not been removed from a liquid extract must be included in the ingredient list.
Information about solvents present (such as alcohol) in many liquid extracts is useful to consumers, but solvents which have not been removed from an extract must already be included in the ingredient list.(5)
3. Information on the concentration of a liquid extract in the form y:z should be optional.
FDA's proposed rules did not propose a requirement for stating the concentration of a liquid extract and interested parties to the proposed rules could not reasonably have anticipated that the final rule would require such information.
AHPA argued, however, that while the use of such information may provide meaningful information to consumers, a requirement to state the concentration as described in the final rules is potentially misleading. The weight of the herbal ingredient at the beginning of the extraction process is only one of several factors which effect the quality or concentration of a liquid herbal extract. A requirement that emphasizes the weight of the starting material and the solvent to the exclusion of all other information, neglects every other element of the manufacturing process, such as time, temperature, pressure, or the quality of the raw materials, and essentially denies, on the label, the value of any current or potential proprietary advances in liquid extract manufacturing technology.
At the same time, AHPA believes that the inclusion of such information may, if properly calculated, provide useful information to consumers. AHPA essentially agrees with the definition of a ratio expressed in the form y:z that is included in the final rule, i.e. that the calculation for a labeled concentration ratio which is stated in the form y:z must be standardized as the ratio of the weight (in grams) of the starting material to the liquid volume (in milliliters) of the solvent, and that the condition of the starting material (i.e., whether it is fresh or dried) must be stated if the starting material is in fresh condition.
AHPA's objection to FDA's regulation is that it is mandatory. By mandating this information, FDA creates an incentive for manufacturers to create high ratios when other factors may be important to the quality of the extract. This would create competitive pressures related to a false and potentially misleading premise. By making this form of declaration optional, FDA will not disadvantage those companies marketing their products on a premise different than this ratio.
4. Quantification of stated constituents of a liquid extract should be stated on a per serving basis.
Some supplement labels claim that the product contains one or more specific constituents of an herb and/or quantifies the amount of the constituent(s). These ingredients are represented both in the form of liquid extracts from which the solvents have not been removed and in the form of extracts from which the solvents have been removed. The inclusion of such information is a fairly recent innovation in the labeling of dietary supplements containing these ingredients. This is very meaningful information -- when it is presented accurately.
AHPA therefore suggested, as a means to technically correct liquid constituent disclosures, that if a product is labeled in a manner which quantifies or names one or more specific contained constituents, compounds, or group of compounds of a botanical, such quantification be stated on the label by weight on a "per serving" basis.
(1.) (21 C.F.R. S 101.36(b)(3)(ii)(C), 62 Fed. Reg. 49825, 49851 (Sept. 23, 1997))
(2.) (21 C.F.R. S 101.36(b)(3)(ii)(B), supra)
(3.) 60 Fed. Reg. 67194, 67216 (Dec. 28, 1995) (to be codified at 21 C.F.R. S 101.36(b)(3)(ii))
(4.) 21 U.S.C. S 343(q)(5)(F)
(5.) 21 C.F.R. S 101.4(a)(1)(g)
Article copyright American Botanical Council.
By Tony Young and Rob McCaleb