Baynes J, Dominiczak M. Medical Biochemistry. New York: Mosby; 1999:182-183.
Fiume Z. Final report on the safety assessment of Malic Acid and Sodium Malate. Int J Toxicol. 2001;20(Suppl 1):47-55.
Malic Acid functions in cosmetic formulations as a pH adjuster, and Sodium Malate functions as a skin conditioning agent-humectant. Malic Acid is reportedly used in almost 50 cosmetic formulations across a range of product types at low concentrations, whereas Sodium Malate is used in only one. As a pH adjuster, Malic Acid is used at low concentrations. One commercial method of preparing Malic Acid is hydration of fumaric acid or maleic acid, and then purified to limit the amount of the starting material present. Because Malic Acid is a component of the Kreb’s cycle, another method is fermentation. Malic Acid was relatively nontoxic in acute toxicity studies using animals. In a chronic oral study, feeding Malic Acid to rats resulted only in weight gain changes and changes in feed consumption. Malic Acid did not cause reproductive toxicity in mice, rats, or rabbits. Malic Acid was a moderate to strong skin irritatant in animal tests, and was a strong ocular irritant. Malic Acid was not mutagenic across a range of genotoxicity tests. Malic Acid was irritating in clinical tests, with less irritation seen as pH of the applied material increased. Patients patch tested with Malic Acid, placed on a diet that avoided foods containing Malic or citric acid, and then challenged with a diet high in Malic and citric acid had both immediate urticarial and delayed contact dermatitis reactions. These data were considered sufficient to determine that Malic Acid and Sodium Malate would be safe at the low concentrations at which these ingredients would be used to adjust pH (even though Sodium Malate is not currently used for that purpose). The data, however, were insufficient to determine the safety of these ingredients when used in cosmetics as other than pH adjusters and specifically, the data are insufficient to determine the safety of Sodium Malate when used as a skin conditioning agent-humectant. The types of data required for the Expert Panel to determine the safety of Sodium Malate as a skin-conditioning agent are: concentration of use data; dermal irritation and sensitization data; and ocular irritation data, if available. The data needed to assess the safety of Malic Acid or Sodium Malate for some function other than as a skin-conditioning agent cannot be specified without knowing the intended function. Were these ingredients to be used as exfoliants, for example, data similar to that included in the Cosmetic Ingredient Review safety assessment of Glycolic Acid would be needed. Until these data are available, it is concluded that the available data are insufficient to support the safety of these ingredients in cosmetic formulations for functions other than use as a pH adjuster.
Baynes J, Dominiczak MH. Medical Biochemistry. New York: Mosby; 1999:162-165.
Russell IJ, Michalek JE, Flechas JD, Abraham GE. Treatment of fibromyalgia syndrome with Super Malic: a randomized, double blind, placebo controlled, crossover pilot study. J Rheumatol. May1995;22(5):953-8.
OBJECTIVE. To study the efficacy and safety of Super Malic, a proprietary tablet containing malic acid (200 mg) and magnesium (50 mg), in treatment of primary fibromyalgia syndrome (FM).
METHODS. Twenty-four sequential patients with primary FM were randomized to a fixed dose (3 tablets bid), placebo controlled, 4-week/course, pilot trial followed by a 6-month, open label, dose escalation (up to 6 tablets bid) trial. A 2-week, medication free, washout period was required before receiving treatment, between blinded courses, and again before starting open label treatment. The 3 primary outcome variables were measures of pain and tenderness but functional and psychological measures were also assessed.
RESULTS. No clear treatment effect attributable to Super Malic was seen in the blinded, fixed low dose trial. With dose escalation and a longer duration of treatment in the open label trial, significant reductions in the severity of all 3 primary pain/tenderness measures were obtained without limiting risks.
CONCLUSIONS. These data suggest that Super Malic is safe and may be beneficial in the treatment of patients with FM. Future placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue therapy for at least 2 months.
Malic acid is a 4-carbon organic acid that is synthesized in humans as one of the steps in the Kreb’s (citric acid) cycle during the production of ATP, which is the body’s primary source of energy. [ Ref. ] Malic acid also occurs naturally in many fruits and vegetables, and its concentration in apples is especially high, which accounts for it often being called “apple acid.” Because of its role in cellular energy production, malic acid may be helpful to individuals suffering from chronic fatigue and fibromyalgia. It has also been suggested that malic acid can help prevent hypoxia. Because of this, some athletes supplement with malic acid, hoping that it will increase the delivery of oxygen to muscle cells, thereby improving stamina and endurance. Malic acid is an abundant naturally occurring organic acid that is also used widely as an additive in the food and beverage industries to acidify wines, acid drinks, fruit juice, soda water, and various soft drinks. Malic acid is also frequently used in cosmetic formulations as a pH adjuster and sodium malate is used in topical cosmetics as a moisturizing agent for the skin. [ Ref. ]
Malic acid is easily absorbed from the gastrointestinal tract.
Toxicities & Precautions
Therapy with malic acid at normal dosage levels has been reported to be safe and without any significant side effects.
Functions In The Body
Malic acid’s primary function in humans is related to its being a primary step in the Kreb’s or citric acid cycle, which results in the production on energy. [ Ref. ]
Chronic Fatigue Syndrome
There are no published studies on the use of malic acid in the treatment of chronic fatigue syndrome (CFS). However, CFS is very similar to fibromyalgia, and many clinicians utilize malic acid to help improve energy production in patients with both conditions.
Research in this area is limited. However, the results from one published study reported that patients taking 1,200 mg of malic acid and 300 mg of magnesium twice daily for six months experienced significant reductions in the severity of pain, tenderness, and psychological components associated with the condition. [ Ref. ]
Symptoms and Causes of Deficency
Malic acid is regularly produced in humans, and no deficiency condition has been identified.
Malic acid is present in many fruits and vegetables. Some of the highest concentrations occur in apples, cranberries, grapes, and cucumbers.