Safety Considerations in Supplement Formulation

Identifying “food standards” have been around a long time. In fact, “something” can only be named as “something” if it meets a certain standard (Code of Federal Regulations (21CFR), section 130). It is clear and simple; neither innovation nor permutations cannot change the basic threshold. This level playing field ensures for bread to be bread it must meet the bread standards of identity, and cannot “mutate” into a mango-floured, anthocyanin-colored, açaí-flavored, cloned-bovine proteinized, selenized-yeast “loaf” that still competes for consumer attention as “B-R-E-A-D”. Standards of identity were originally promulgated to provide a measuring stick (and “club”) for egregious and malicious adulteration and misbranding. Original standards of identity resembled recipes for home-made counterparts, describing the composition of foods in exquisite detail. FDA’s thinking in providing such detailed mandatory composition was to preclude modifications of basic, staple, food formulas that would allow consumer deception to occur, and address a concern that the burgeoning synthetic food additives of questionable safety would insidiously find their way into foods prematurely.

Standards of identity or at least “standards of expectations” should also be relevant to consumers of dietary supplements and natural products. Most of us take multivitamin/mineral supplements that usually contain about a dozen basic vitamins and about the same number of minerals. That is the concept behind taking one multivitamin—to get the most needed nutrients at the right levels at about the right frequency.

However, the market of late has become more bizarre, with multis including an ever-escalating breadth of micronutrients (many of dubious necessity) and permutations. Boron, tin, nickel and vanadium have become new regulars, while aluminum, germanium, gold and platinum are touted as micro-micronutrients. Some supplements are so laden with overt toxic moieties, such as arsenic, lead and mercury or rare earths, such as strontium, uranium and thallium, that it is small wonder the entire periodic table is not listed as the complete list of all the required nutrients.

Formulations are being fine-tuned to meet specific demographics and niche users, such as adolescents, seniors, men, women, children, athletes, etc. In the past, formulators combined ingredients and the products were marketed as “joint formula,” “menopause formula” or “gastrointestinal formula.” The newest angle is tailoring specific nutritional combinations to specific, ethical, pharmaceutical medications. For example, one manufacturer supplies a proprietary mixture of vitamin B6, B12 and D, plus folic acid and calcium to use with heartburn and acid reflux medications such as Nexium®, Prevacid® and Prilosec®. This firm also offers a combination of vitamins B6, B12, folic acid and coenzyme Q10 (CoQ10) for use with cholesterol medications, including Lipitor®, Zocor® and Prevachol®. Has nutrigenomics been supplanted with supplementomics?

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