Dietary supplements caffeine

Obtain a thorough medication use history, including present and past drugs prescription and nonprescription drugs the patient s self-assessment of response and side-effect problems use of alcohol, tobacco, caffeine, and illicit substances and use of herbal products and dietary supplements, as well as any allergies and adherence difficulties. 

Jacob P III, Haller CA, Duan M, Yu L, Peng M, et al. 2004. Determination of ephedra alkaloid and caffeine concentrations in dietary supplements and biological fluids. J Anal Toxicol 28 152. 

Stimulant drugs commonly abused in the USA include methamphetamine ("crank," "crystal"), methylenedioxymethamphetamine (MDMA, "ecstasy"), and cocaine ("crack") as well as pharmaceuticals such as pseudoephedrine (Sudafed) and ephedrine (as such and in the herbal agent Ma-huang) (see Chapter 32). Caffeine is often added to dietary supplements sold as "metabolic enhancers" or "fat-burners" and is also sometimes combined with pseudoephedrine in underground pills sold as amphetamine substitutes. 

The molecular structure of ephedra resembles that of amphetamine, a stimulant. Dietary supplement product manufacturers often mixed caffeine with ephedra. Some experts believe that caffeine probably enhances or heightens ephedra s stimulant effects. Ephedra may also be combined with other herbs in supplements, depending on the desired effects. 

The slimming aid LipoKinetix contains norephedrine hydrochloride, sodium usinate, 3,5-diiodothyronine, yohimbine hydrochloride, and caffeine. Seven patients all had the signs and symptoms of acute toxic hepatitis after taking this dietary supplement (176). Three patients had taken no other concomitant medications. All recovered spontaneously after LipoKinetix was withdrawn. 

Haller CA, Jacob P III, Benowitz NL. Pharmacology of ephedra alkaloids and caffeine after single-dose dietary supplement use. Clin Pharmacol Ther 2002 71(6) 421 132. 

A drug product that contains the same active constituent as a botanical product would be regulated according to different paths, as long as they are marketed with different intent. The combination of caffeine with any other stimulant, such as ephedrine alkaloids2, may not be sold as an OTC drag product (20). However, dietary supplement products that contain ma huang (a source of ephedrine) and natural product stimulants such as kola nut (50% caffeine) are permitted on the market under DSHEA. 

Haller, C., Duan, M., Benowitz, N.L., and Jacob, P., 3rd 2004. Concentrations of ephedra alkaloids and caffeine in commercial dietary supplements. J. Analyt. Toxicol. 28, 145-151. 

Ephedrine and pseudoephedrine have been measured in guinea pig plasma using HPLC with fluorescence detection, following precolumn derivatization with 5-dimethylamino-napthalene-1-sulfonyl chloride in acetonitrile. The mobile phase was 0.6% phosphate buffer (pH 6.5)-methanol (3 8 v/v). Jacob et al. developed an LC-atmospheric pressure chemical ionization MS-MS method for the quantitaion of various alkaloids found in ephedra-containing dietary supplements and also in plasma and urine from subjects using these supplements. Using this method, the concentrations of ephedrine, pseudoephedrine, norephedrine, norpseudoephedrine, methylephedrine, methylpseudoephedrine and caffeine were determined in low nanogram quantities in plasma and urine. The analytical cycle time for this method was 12 min. 

Most of these products are legally considered neither food nor drugs and, therefore, are not regulated by the FDA (Dietary Supplement Health and Education Act, 1994). Toxicity may be related to the active Ingredlent(s) or to Impurities, contaminants, or adulterants In the product. See also Caffeine (p 142), Essential Oils (p 147), Salicylates (p 331), and Vitamins (p 366). 

The American Herbal Products Association has established a trade requirement (AHPA 2011) that dietary supplement products that contain caffeine, whether as a direct ingredient or as a constituent of herbal ingredients, be labeled to disclose the presence of caffeine in the product and the quantity of added caffeine if greater than 25 mg be formulated and labeled in a manner to recommend a maximum of 200 mg of caffeine per serving, not more often than every 3 to 4 hours and bear the following or similar statement on the label of any dietary supplement that contains caffeine in sufficient quantity to warrant such labeling ... 

The American Herbal Products Association has established a trade requirement (AHPA 2011) that dietary supplement products that contain caffeine, whether as a direct ingredient or as a constituent of herbal ingredients, be labeled... 

The label of caffeine-containing dietary supplements discloses the presence of caffeine in the product. 

The label or labeling of caffeine containing dietary supplements, except for such supplements as are described in paragraph 3 below, discloses the quantity of caffeine per recommended serving of the dietary supplement, stated in both milligrams per serving and in equivalent approximate cups of coffee, where 100 mg of caffeine represents one cup of coffee. 

The label of caffeine-containing dietary supplements discloses the presence of caffeine, but not necessarily the quantity of caffeine per recommended serving, if at least one of the following conditions is met ... 

The amount of caffeine per recommended serving of the caffeine-containing dietary supplement is less than 25 mg. 

Caffeine-containing dietary supplements are formulated and labeled in a manner to recommend a maximum of 200 mg of caffeine per serving, not more often than every 3 to 4 hours. 

The following or similar statement is included on the label of any dietary supplement that contains caffeine in sufficient quantity to warrant such labeling ... 

---