- Email: [email protected]
Esophageal Injury by Apple Cider Vinegar Tablets and Subsequent Evaluation of Products
RESEARCH Research and Professional Briefs
Esophageal Injury by Apple Cider Vinegar Tablets and Subsequent Evaluation of Products LAURA L. HILL, MS, RD; LOGAN H. WOODRUFF; JERALD C. FOOTE, PhD, RD; MORELA BARRETO-ALCOBA
ABSTRACT Apple cider vinegar products are advertised in the popular press and over the Internet for treatment of a variety of conditions. After an adverse event was reported to the authors, eight apple cider vinegar tablet products were tested for pH, component acid content, and microbial growth. Considerable variability was found between the brands in tablet size, pH, component acid content, and label claims. Doubt remains as to whether apple cider vinegar was in fact an ingredient in the evaluated products. The inconsistency and inaccuracy in labeling, recommended dosages, and unsubstantiated health claims make it easy to question the quality of the products. J Am Diet Assoc. 2005;105:1141-1144.
A
pple cider vinegar products are advertised in the popular press and over the Internet for treatment of a variety of conditions, including aging, weight loss, hemorrhoids, high blood pressure, arthritis, sore throat, and indigestion (1-3). A 48-year-old woman reported an adverse event to the authors. She developed severe pain and difficulty swallowing after an apple cider vinegar tablet became lodged in her throat for approximately 30 minutes. A review of the medical record revealed possible injury, with tenderness of the larynx and pain during swallowing and neck palpation. An esophagogastroduodenoscopy performed 14 days later appeared normal; however, 6 months after the initial event, the patient reported continued pain and difficulty swallowing. Subsequently, apple cider vinegar products were gathered and evaluated for pH and for component acids (acetic, citric, malic, and lactic) using high-performance liquid chromatography (HPLC). After noticing potential
L. L. Hill is a doctoral candidate in Human Environmental Science/Food Science, L. H. Woodruff is a graduate research assistant, J. C. Foote is assistant professor, Department of Human Environmental Science (Human Nutrition), and M. Barreto-Alcoba is a doctoral candidate, Department of Food Science, University of Arkansas, Fayetteville. Address correspondence to Laura L. Hill, MS, RD, Department of Human Environmental Science, University of Arkansas, HOEC 118, Fayetteville, AR 72701. E-mail: [email protected] Copyright © 2005 by the American Dietetic Association. 0002-8223/05/10507-0010$30.00/0 doi: 10.1016/j.jada.2005.04.003
© 2005 by the American Dietetic Association
microbial growth in samples prepared at room temperature, bacterial (aerobic plate counts) and yeast/mold counts were conducted. METHODS A convenience sample of eight apple cider vinegar tablet products was obtained from grocery stores, health food stores, a pharmacy in Northwest Arkansas, and an Internet site. One of the samples (sample H) was the same brand ingested by the woman in the case described here. HPLC and pH measurements were conducted at a single laboratory. Positive and negative controls, including blanks and acid standards, were used in HPLC analysis. Triplicate samples were used in all tests and none of the samples were blinded to researchers. In preparation for HPLC analysis, samples from each brand were weighed and dissolved in 5 mL HPLC-grade water (Millipore purification system, Millipore, Billerica, MA) at 4°C for 20 hours. Samples were vortexed, centrifuged, and filtered. HPLC was performed with a Waters Chromatography System (Millipore) at a flow rate of 0.5 mL per minute and an injection valve set at 10 L with a variable ultraviolet wavelength detector set at 210 nm. The separation was performed with a Carbohydrate Analysis Column (3.9⫻300 mm) (Waters Chromatography, Millipore). The mobile phase for all the samples was 0.1% H3PO4 except for sample E, which required 0.3% H3PO4. For the microbial analysis, AOAC International methods (4) were used to obtain aerobic plate counts and yeast/mold counts for each of the products. Serial dilutions were plated on Petrifilm Aerobic Count Plates as well as Yeast and Mold Count Plates (3M Company, St Paul, MN). RESULTS AND DISCUSSION Considerable variability was found between brands. The pH readings for all samples were acidic and ranged from 2.9 to 5.7 (Table). Acetic acid in the samples ranged from 1.04% to 10.57%. Citric acid ranged from 0% to 18.5%. None of the samples contained lactic acid. Malic acid was present in sample G only (49.12%). Average weight per tablet ranged from 380 to 758 mg. Dosage recommendations varied tremendously from one tablet (300 mg) daily to two tablets (500 mg) three times daily. According to the Food and Drug Administration Office of Regulatory Affairs Compliance Policy number 7109.22 (5), there is not a standard of identity for any variety of vinegar. Acetic acid is the identifying acid in vinegars (6). However, in addition to acetic acid, Natera and colleagues found apple cider vinegar also contained citric and lactic
Journal of the AMERICAN DIETETIC ASSOCIATION
1141
Table. Tablet mass, pH, and percent component acids for apple cider vinegar tablet samples Component Acidsab Sample
Tablet mass (mg)
pH readings
Acetic acid (%)
Citric acid (%)
A B C D Ed F G H
4™ mean⫾SD c ™3 758⫾13 492⫾8 646⫾2 380⫾10 681⫾11 644⫾6 732⫾4 646⫾1
5.2 5.7 5.1 4.5 5.6 5.4 2.9 4.6
4™™™™™™™™™™™™ mean⫾SD ™™™™™™™™™™™™™ 3 1.04⫾0.11 0.34⫾.02 5.35⫾0.32 12.89⫾.45 2.22⫾0.37 0.24⫾0.11 3.21⫾0.07 18.54⫾0.68 3.65⫾0.54 NAe 8.88⫾0.94 8.38⫾0.913 1.91⫾0.05 0.00 10.57⫾0.17 9.89⫾0.07
a
Component acid was expressed as the percent of the specific acid tested present in the tablet, not as a percent of the total acid content. There was no lactic acid found in any of the samples. Only sample G contained malic acid at 49.12%. c SD⫽standard deviation. d Neither total separation nor identification was achieved, possibly due to the presence of ginger and Garcinia cambogia listed on the label. e NA⫽not applicable. b
acids (6), while Giumanini and colleagues found malic and lactic acids (7). Only one sample contained malic acid, none of the samples contained lactic acid, and citric acid content varied noticeably. This led the researchers to question whether any of the products tested indeed contained apple cider vinegar as an ingredient. Product labels did not appear to be accurate regarding the amount of acetic acid present. Sample C claimed to contain 4% acetic acid and was determined to contain 2.22%. Sample D claimed to contain a minimum of 35% acetic acid, but was found to contain only 3.2%, with the majority of the acid present as citric (18.54%). Sample G also claimed to have a minimum of 35% acetic acid, but only contained 2% with the predominant acid being malic (49.12%). If samples D and G had, in fact, contained the amount of acid claimed on the label, they could be considered poisonous, as indicated by the Consumer Product Safety Commission, which states that an “acetic acid preparation containing free or chemically unneutralized acetic acid in concentration of 20% or more shall be deemed a poison” (8). Apple cider vinegar tablets could also be considered toxic according to the Code of Federal Regulations because personal injury occurred when swallowed (8). Under these guidelines, apple cider vinegar tablets could possibly be considered a corrosive agent due to their ability to destroy living tissues (8). Severity of acid chemical burns can be attributed to length of contact time, pH, volume, concentration, and physical form of the acid (9). Despite the fact that the esophagus is described as relatively unaffected by acid ingestion (10), the concentration of acid in sample H in conjunction with the contact time was sufficient to cause injury in the case described here. Five of the samples contained component acid concentrations 3 to 10 times the amount found in household vinegar, which is typically 5% acid. Two samples had greater component acid content and were more acidic than the brand (sample H) ingested by the woman described here. Product G had the highest component acid content and was one of the larg-
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July 2005 Volume 105 Number 7
est tablets; therefore, of all the samples tested, it could present the greatest risk of injury. No bacterial growth was detected on aerobic count plates. Samples A, B, and E had yeast and mold counts in the range of 103 to 105 colony-forming units/g. Sample E claimed to be yeast-free, but tested positive for yeast and mold contamination—yet another label inaccuracy discovered in the testing of these products. However, samples D and H also claimed to be yeast-free and this proved to be accurate.
As health care professionals, the maxim “First, do no harm” is always appropriate when advising patients about dietary supplement use. Some of the labels imply that taking this product will aid in weight control or loss, and it is unclear if these claims are within the allowed structure/function claims for dietary supplements. Also, sample F, which was obtained on the Internet, claimed to be “a blood thinner, detoxifier, and/or diuretic,” have “cleansing, healing, and germ fighting abilities,” and to aid in “weight loss, digestive difficulties, joint pain and infections.” This product appeared to be promoted as a drug according to the Federal Food Drug and Cosmetic Act (11). Previously published reports have described adverse events as a result of the use of vinegar home remedies. An infant received first-degree chemical burns after vinegar was applied topically to reduce a fever (12). A woman suffered a deep ulcer on her foot after a topical vinegar treatment was applied for 2 hours (13). An 8-year-old girl was treated for head lice with vinegar, which inadvertently spilled on her face and resulted in swelling and burns (14). Evidence of adverse effects continues to be linked to dietary supplement use (15). Recent adverse events include supplements that caused hepatic sequelae (16-
21)— one of which required a liver transplant (22), renal sequelae (23,24), and neurotoxicity (25). Other supplements were adulterated with prescription drugs (26,27), contained contaminants such as lead (28,29), or did not contain the stated herb (30,31). Herb⫺drug interactions continue to be documented in the literature (32-38). Limitations of this study include the small sample size and absence of intrabrand replication. However, results of this study should raise concern about the safety and quality of these supplements. CONCLUSIONS Dietetics professionals should continue to be vigilant in eliciting information from their clients about their dietary supplement use. In addition, clients should be encouraged to inform their physicians of all supplements in use. Dietetics professionals are in a unique position to provide science-based, credible information to their clients, especially those at high risk, who may have greater potential for herb⫺drug interactions. The risks associated with these products often may be greater than any possible benefit. The inconsistency and inaccuracy in labeling, variability in dosage recommendations, and unsubstantiated health claims cause suspicion about the safety and quality of these particular products. In general, dietetics professionals should, at the very least, advise caution when discussing dietary supplements. A thorough review of the literature concerning the safety and efficacy of the supplement(s) in question should be conducted to better assist patients in making informed decisions. This may not always be practical in a clinical setting; however, dietetics professionals have authored useful references pertaining to dietary supplements with substantial documentation from the literature (39-41). As health care professionals, the maxim “First, do no harm” is always appropriate when advising patients about dietary supplement use. References 1. Goldstein L. Our four favorite healing vinegar remedies. Prevention. 2000;52:255. 2. Jacobs S. The cultured club: Fantastic fermented foods. Vegetarian Times. 1984;80:44-48. 3. Anonymous. Some ACV a day to keep the doctor away. Better Nutrition. 2002;64:22. 4. Downes FP, Ito K, eds. Compendium of Methods for the Microbiological Examination of Foods. 4th ed. Washington, DC: American Public Health Association; 2001. 5. Food and Drug Administration. Office of Regulatory Affairs. Section 525.825. Vinegar, Definitions—Alteration with Vinegar Eels (CPG 7109.22). Available at: http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/ cpg525-825.html. Accessed September 14, 2004. 6. Natera R, Castro R, Garcia-Moreno MV, Hernadez MJ, Garica-Barroso C. Chemometric studies of vinegars from different raw materials and processes of production. J Agric Food Chem. 2003;51:3345-3351. 7. Giumanini AG, Verardo G, Martina DD, Toniutti N. Improved method for the analysis of organic acids and new derivatization of alcohols in complex natural
8.
9. 10.
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19.
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aqueous matrixes: Application to wine and apple vinegar. J Agric Food Chem. 2001;49:2875-2882. Food and Drug Administration. Code of Federal Regulations. Title 16, Commercial Practices. Chap. 2. Part 1500. 2003. Available at: www.access.gpo.gov/nara/cfr/ waisidx_03/16cfr1500_03.html. Accessed August 12, 2004. Ramasamy K, Gumaste VV. Corrosive ingestion in adults. J Clin Gastroenterol. 2003;37:119-124. Neimark S, Rogers AI. Chemical injury of the esophagus. In: Berk JE, ed. Bockus Gastroenterology. 4th ed. Philadelphia, PA: WB Saunders Company; 1985: 769-776. United States Code. Title 21. Food and Drugs. Chap. 9. Sec. 321. 2003. Available at: http://frwebgate. access . gpo . gov / cgi-bin / getdoc.cgi?dbname⫽browse_ usc&docid⫽Cite:⫹21USC321. Accessed August 12, 2004. Korkmaz A, Sahiner U, Yurdakok M. Chemical burn caused by topical vinegar application in a newborn infant. Pediatr Dermatol. 2000;17:34-36. Kuniyuki S, Oonishi H. Chemical burn from acetic acid with deep ulceration. Contact Dermatitis. 1997; 36:169-170. Benmeier P, Lusthaus S, Weinberg A, Neuman A, Eldad A. Facial chemical burn. Burns. 1994;20:282. Palmer ME, Haller C, McKinney PE, Klein-Schwartz W, Tschirgi A, Smolinske SC, Woolf A, Sprague BM, Ko R, Everson G, Nelson LS, Dodd-Butera T, Bartlett WD, Landzberg BR. Adverse events associated with dietary supplements: An observational study. Lancet. 2003;361:101-106. Shad JA, Chinn CG, Brann OS. Acute hepatitis after ingestion of herbs. South Med J. 1999;92:1095-1097. Sleeper RB, Kennedy SM. Adverse reaction to a dietary supplement in an elderly patient. Ann Pharmacother. 2003;37:83-86. Estes JD, Stolpman D, Olyaei A, Corless CL, Ham JM, Schwartz JM, Orloff SL. High prevalence of potentially hepatotoxic herbal supplement use in patients with fulminant hepatic failure. Arch Surg. 2003;138:852-858. Favreau JT, Ryu ML, Braunstein G, Orshansky G, Park SS, Coody GL, Love LA, Fong T. Severe hepatoxicity associated with the dietary supplement LipoKinetix. Ann Intern Med. 2002;136:590-595. Stickel F, Egerer G, Seitz HK. Hepatoxicity of botanicals. Public Health Nutr. 2000;3:113-124. Adachi M, Saito H, Kobayashi H, Horie Y, Kato S, Yoshioka M, Ishii H. Hepatic injury in 12 patients taking the herbal weight loss aids Chaso or Onshido. Ann Intern Med. 2003;139:488-492. Neff GW, O’Brien C, Montalbano M, DeManno A, Kahn S, Safdar K, Nishida S, Tzakis A. Consumption of dietary supplements in a liver transplant population. Liver Transplant. 2004;10:881-885. Gold LS, Slone TH. Aristolochic acid, an herbal carcinogen, sold on the Web after FDA alert. N Engl J Med. 2003;349:1576-1577. Mueller BA, Scott MK, Sowinski KM, Prag KA. Noni juice (Morinda citrifolia): Hidden potential for hyperkalemia. Am J Kidney Dis. 2000;35:310-312. Ize-Ludlow D, Ragone S, Bruck IS, Bernstein JN,
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26.
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28.
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30. 31. 32.
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Duchowny M, Garcia Peña BM. Neurotoxicities in infants seen with the consumption of star anise tea. Pediatrics. 2004;114:e653-e656. Available at: www.pediatrics.org/cgi/doi/10.1542/peds.2004-0058. Accessed November 8, 2004. United States Food and Drug Administration. FDA warns consumers that Actra-RX “dietary supplements” promoted for sexual enhancement contains undeclared prescription drug ingredient. FDA Talk Paper TO4-47. November 2, 2004. Available at: www. fda.gov/bbs/topics/ANSWERS/2004/ANS01322.html. Accessed November 8, 2004. Wood DM, Athwal S, Panahloo A. The advantages and disadvantages of an ‘herbal’ medicine in a patient with diabetes mellitus: A case report. Diabet Med. 2004;21:625-627. Centers for Disease Control. Lead poisoning associated with Ayurvedic medications—Five states 20002003. MMWR Morb Mortal Wkly Rep. 2004;53:582584. Available at: www.cdc.gov/mmwr/preview/ mmwrhtml/mm5326a3.htm. Accessed July 9, 2004. Dolan SP, Nortrup DA, Bolger PM, Capar SG. Analysis of dietary supplements for arsenic, cadmium, mercury, and lead using inductively coupled plasma mass spectrometry. J Agric Food Chem. 2003;51: 1307-1312. Garrard J, Harms S, Eberly LE, Matiak A. Variations in product choices of frequently purchased herbs: Caveat emptor. Arch Intern Med. 2003;163:2290-2295. Gilroy CM, Steiner JF, Byers T, Shapiro H, Georgian W. Echinacea and truth in labeling. Arch Intern Med. 2003;163:699-704. Miller LG. Herbal medicinals—Selected clinical con-
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33.
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siderations focusing on known or potential drug-herb interactions. Arch Intern Med. 1998;158:2200-2211. Izzo AA, Ernst E. Interactions between herbal medicines and prescribed drugs—A systematic review. Drugs. 2001;61:2163-2175. Dergal JM, Gold JL, Laxer DA, Lee MSW, Binns MA, Lanctot KL, Freedman M, Rochon PA. Potential interactions between herbal medicines and conventional drug therapies used by older adults attending a memory clinic. Drugs Aging. 2002;19:879-886. Aggarwal A, Ades PA. Interactions of herbal remedies with prescription cardiovascular medications. Coron Artery Dis. 2001;12:581-584. Abebe W. Herbal medication: Potential for adverse interactions with analgesic drugs. J Clin Pharm Ther. 2002;27:391-401. Brazier NC, Levine MAH. Drug-herb interaction among commonly used conventional medicines: A compendium for health care professionals. Am J Ther. 2003;10:163-169. Sparreboom A, Cox MC, Acharya MR, Figg WD. Herbal remedies in the United States: Potential adverse interactions with anticancer agents. J Clin Oncol. 2004;22:2489-2503. Fragakis AS. The Health Professional’s Guide to Popular Dietary Supplements. 2nd ed. Chicago, IL: American Dietetic Association; 2003. Herr SM. Herb-Drug Interaction Handbook. 2nd ed. Castleton, NY: Church Street Books; 2002. DeBusk RM. A practical guide to herbal supplements for nutrition practitioners. Top Clin Nutr. 2001;16: 53-67.
Esophageal Injury by Apple Cider Vinegar Tablets and Subsequent Evaluation of Products LAURA L. HILL, MS, RD; LOGAN H. WOODRUFF; JERALD C. FOOTE, PhD, RD; MORELA BARRETO-ALCOBA
ABSTRACT Apple cider vinegar products are advertised in the popular press and over the Internet for treatment of a variety of conditions. After an adverse event was reported to the authors, eight apple cider vinegar tablet products were tested for pH, component acid content, and microbial growth. Considerable variability was found between the brands in tablet size, pH, component acid content, and label claims. Doubt remains as to whether apple cider vinegar was in fact an ingredient in the evaluated products. The inconsistency and inaccuracy in labeling, recommended dosages, and unsubstantiated health claims make it easy to question the quality of the products. J Am Diet Assoc. 2005;105:1141-1144.
A
pple cider vinegar products are advertised in the popular press and over the Internet for treatment of a variety of conditions, including aging, weight loss, hemorrhoids, high blood pressure, arthritis, sore throat, and indigestion (1-3). A 48-year-old woman reported an adverse event to the authors. She developed severe pain and difficulty swallowing after an apple cider vinegar tablet became lodged in her throat for approximately 30 minutes. A review of the medical record revealed possible injury, with tenderness of the larynx and pain during swallowing and neck palpation. An esophagogastroduodenoscopy performed 14 days later appeared normal; however, 6 months after the initial event, the patient reported continued pain and difficulty swallowing. Subsequently, apple cider vinegar products were gathered and evaluated for pH and for component acids (acetic, citric, malic, and lactic) using high-performance liquid chromatography (HPLC). After noticing potential
L. L. Hill is a doctoral candidate in Human Environmental Science/Food Science, L. H. Woodruff is a graduate research assistant, J. C. Foote is assistant professor, Department of Human Environmental Science (Human Nutrition), and M. Barreto-Alcoba is a doctoral candidate, Department of Food Science, University of Arkansas, Fayetteville. Address correspondence to Laura L. Hill, MS, RD, Department of Human Environmental Science, University of Arkansas, HOEC 118, Fayetteville, AR 72701. E-mail: [email protected] Copyright © 2005 by the American Dietetic Association. 0002-8223/05/10507-0010$30.00/0 doi: 10.1016/j.jada.2005.04.003
© 2005 by the American Dietetic Association
microbial growth in samples prepared at room temperature, bacterial (aerobic plate counts) and yeast/mold counts were conducted. METHODS A convenience sample of eight apple cider vinegar tablet products was obtained from grocery stores, health food stores, a pharmacy in Northwest Arkansas, and an Internet site. One of the samples (sample H) was the same brand ingested by the woman in the case described here. HPLC and pH measurements were conducted at a single laboratory. Positive and negative controls, including blanks and acid standards, were used in HPLC analysis. Triplicate samples were used in all tests and none of the samples were blinded to researchers. In preparation for HPLC analysis, samples from each brand were weighed and dissolved in 5 mL HPLC-grade water (Millipore purification system, Millipore, Billerica, MA) at 4°C for 20 hours. Samples were vortexed, centrifuged, and filtered. HPLC was performed with a Waters Chromatography System (Millipore) at a flow rate of 0.5 mL per minute and an injection valve set at 10 L with a variable ultraviolet wavelength detector set at 210 nm. The separation was performed with a Carbohydrate Analysis Column (3.9⫻300 mm) (Waters Chromatography, Millipore). The mobile phase for all the samples was 0.1% H3PO4 except for sample E, which required 0.3% H3PO4. For the microbial analysis, AOAC International methods (4) were used to obtain aerobic plate counts and yeast/mold counts for each of the products. Serial dilutions were plated on Petrifilm Aerobic Count Plates as well as Yeast and Mold Count Plates (3M Company, St Paul, MN). RESULTS AND DISCUSSION Considerable variability was found between brands. The pH readings for all samples were acidic and ranged from 2.9 to 5.7 (Table). Acetic acid in the samples ranged from 1.04% to 10.57%. Citric acid ranged from 0% to 18.5%. None of the samples contained lactic acid. Malic acid was present in sample G only (49.12%). Average weight per tablet ranged from 380 to 758 mg. Dosage recommendations varied tremendously from one tablet (300 mg) daily to two tablets (500 mg) three times daily. According to the Food and Drug Administration Office of Regulatory Affairs Compliance Policy number 7109.22 (5), there is not a standard of identity for any variety of vinegar. Acetic acid is the identifying acid in vinegars (6). However, in addition to acetic acid, Natera and colleagues found apple cider vinegar also contained citric and lactic
Journal of the AMERICAN DIETETIC ASSOCIATION
1141
Table. Tablet mass, pH, and percent component acids for apple cider vinegar tablet samples Component Acidsab Sample
Tablet mass (mg)
pH readings
Acetic acid (%)
Citric acid (%)
A B C D Ed F G H
4™ mean⫾SD c ™3 758⫾13 492⫾8 646⫾2 380⫾10 681⫾11 644⫾6 732⫾4 646⫾1
5.2 5.7 5.1 4.5 5.6 5.4 2.9 4.6
4™™™™™™™™™™™™ mean⫾SD ™™™™™™™™™™™™™ 3 1.04⫾0.11 0.34⫾.02 5.35⫾0.32 12.89⫾.45 2.22⫾0.37 0.24⫾0.11 3.21⫾0.07 18.54⫾0.68 3.65⫾0.54 NAe 8.88⫾0.94 8.38⫾0.913 1.91⫾0.05 0.00 10.57⫾0.17 9.89⫾0.07
a
Component acid was expressed as the percent of the specific acid tested present in the tablet, not as a percent of the total acid content. There was no lactic acid found in any of the samples. Only sample G contained malic acid at 49.12%. c SD⫽standard deviation. d Neither total separation nor identification was achieved, possibly due to the presence of ginger and Garcinia cambogia listed on the label. e NA⫽not applicable. b
acids (6), while Giumanini and colleagues found malic and lactic acids (7). Only one sample contained malic acid, none of the samples contained lactic acid, and citric acid content varied noticeably. This led the researchers to question whether any of the products tested indeed contained apple cider vinegar as an ingredient. Product labels did not appear to be accurate regarding the amount of acetic acid present. Sample C claimed to contain 4% acetic acid and was determined to contain 2.22%. Sample D claimed to contain a minimum of 35% acetic acid, but was found to contain only 3.2%, with the majority of the acid present as citric (18.54%). Sample G also claimed to have a minimum of 35% acetic acid, but only contained 2% with the predominant acid being malic (49.12%). If samples D and G had, in fact, contained the amount of acid claimed on the label, they could be considered poisonous, as indicated by the Consumer Product Safety Commission, which states that an “acetic acid preparation containing free or chemically unneutralized acetic acid in concentration of 20% or more shall be deemed a poison” (8). Apple cider vinegar tablets could also be considered toxic according to the Code of Federal Regulations because personal injury occurred when swallowed (8). Under these guidelines, apple cider vinegar tablets could possibly be considered a corrosive agent due to their ability to destroy living tissues (8). Severity of acid chemical burns can be attributed to length of contact time, pH, volume, concentration, and physical form of the acid (9). Despite the fact that the esophagus is described as relatively unaffected by acid ingestion (10), the concentration of acid in sample H in conjunction with the contact time was sufficient to cause injury in the case described here. Five of the samples contained component acid concentrations 3 to 10 times the amount found in household vinegar, which is typically 5% acid. Two samples had greater component acid content and were more acidic than the brand (sample H) ingested by the woman described here. Product G had the highest component acid content and was one of the larg-
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July 2005 Volume 105 Number 7
est tablets; therefore, of all the samples tested, it could present the greatest risk of injury. No bacterial growth was detected on aerobic count plates. Samples A, B, and E had yeast and mold counts in the range of 103 to 105 colony-forming units/g. Sample E claimed to be yeast-free, but tested positive for yeast and mold contamination—yet another label inaccuracy discovered in the testing of these products. However, samples D and H also claimed to be yeast-free and this proved to be accurate.
As health care professionals, the maxim “First, do no harm” is always appropriate when advising patients about dietary supplement use. Some of the labels imply that taking this product will aid in weight control or loss, and it is unclear if these claims are within the allowed structure/function claims for dietary supplements. Also, sample F, which was obtained on the Internet, claimed to be “a blood thinner, detoxifier, and/or diuretic,” have “cleansing, healing, and germ fighting abilities,” and to aid in “weight loss, digestive difficulties, joint pain and infections.” This product appeared to be promoted as a drug according to the Federal Food Drug and Cosmetic Act (11). Previously published reports have described adverse events as a result of the use of vinegar home remedies. An infant received first-degree chemical burns after vinegar was applied topically to reduce a fever (12). A woman suffered a deep ulcer on her foot after a topical vinegar treatment was applied for 2 hours (13). An 8-year-old girl was treated for head lice with vinegar, which inadvertently spilled on her face and resulted in swelling and burns (14). Evidence of adverse effects continues to be linked to dietary supplement use (15). Recent adverse events include supplements that caused hepatic sequelae (16-
21)— one of which required a liver transplant (22), renal sequelae (23,24), and neurotoxicity (25). Other supplements were adulterated with prescription drugs (26,27), contained contaminants such as lead (28,29), or did not contain the stated herb (30,31). Herb⫺drug interactions continue to be documented in the literature (32-38). Limitations of this study include the small sample size and absence of intrabrand replication. However, results of this study should raise concern about the safety and quality of these supplements. CONCLUSIONS Dietetics professionals should continue to be vigilant in eliciting information from their clients about their dietary supplement use. In addition, clients should be encouraged to inform their physicians of all supplements in use. Dietetics professionals are in a unique position to provide science-based, credible information to their clients, especially those at high risk, who may have greater potential for herb⫺drug interactions. The risks associated with these products often may be greater than any possible benefit. The inconsistency and inaccuracy in labeling, variability in dosage recommendations, and unsubstantiated health claims cause suspicion about the safety and quality of these particular products. In general, dietetics professionals should, at the very least, advise caution when discussing dietary supplements. A thorough review of the literature concerning the safety and efficacy of the supplement(s) in question should be conducted to better assist patients in making informed decisions. This may not always be practical in a clinical setting; however, dietetics professionals have authored useful references pertaining to dietary supplements with substantial documentation from the literature (39-41). As health care professionals, the maxim “First, do no harm” is always appropriate when advising patients about dietary supplement use. References 1. Goldstein L. Our four favorite healing vinegar remedies. Prevention. 2000;52:255. 2. Jacobs S. The cultured club: Fantastic fermented foods. Vegetarian Times. 1984;80:44-48. 3. Anonymous. Some ACV a day to keep the doctor away. Better Nutrition. 2002;64:22. 4. Downes FP, Ito K, eds. Compendium of Methods for the Microbiological Examination of Foods. 4th ed. Washington, DC: American Public Health Association; 2001. 5. Food and Drug Administration. Office of Regulatory Affairs. Section 525.825. Vinegar, Definitions—Alteration with Vinegar Eels (CPG 7109.22). Available at: http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/ cpg525-825.html. Accessed September 14, 2004. 6. Natera R, Castro R, Garcia-Moreno MV, Hernadez MJ, Garica-Barroso C. Chemometric studies of vinegars from different raw materials and processes of production. J Agric Food Chem. 2003;51:3345-3351. 7. Giumanini AG, Verardo G, Martina DD, Toniutti N. Improved method for the analysis of organic acids and new derivatization of alcohols in complex natural
8.
9. 10.
11.
12. 13. 14. 15.
16. 17. 18.
19.
20. 21.
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