User’s Guide to Natural and Dietary Supplements Related to Law in Maryland

The Dietary Supplement Health and Education Act of 2009 (DSHEA) in the United States established the regulatory structure of food-like supplements via the FDA. The FDA regulates dietary supplements safety, production, and labeling, and our partners at the Federal Trade Commission are responsible for overseeing the marketing of these products. In addition, if the label includes any statement that a product will affect body structure or function, an assertion about general wellness, or an assertion about benefits related to classic nutritional deficiencies, a dietary supplement also should bear a disclaimer that Food and Drug Administration has not evaluated that statement, and the product is not intended to diagnose, treat, cure, or prevent any illness.

Further, there is no requirement that manufacturers submit evidence of product safety to FDA prior to marketing a dietary supplement unless the supplement contains a new dietary ingredient (a dietary ingredient that was not marketed in this country prior to October 15, 1994) that has not been preserved in the food supply as an article used for food in a form in which the food has not been chemically altered (21 U.S.C. FDA regulates dietary supplements pursuant to a set of regulations distinct from the regulations governing ordinary food and drug products. Many prescription drugs and over-the-counter medications are also made with botanicals, but those products only have refined ingredients, and are regulated by FDA.

Dietary Supplements Related to Law in Maryland

Herbal supplements typically do not get as much scientific review, nor are they subject to as strict regulation as medications. However, herbs and botanical products – including products labelled natural – may have powerful effects on the body. Consumption of food and herbs supplements is prevalent among inpatients, and interactions are frequently missed by physicians.

The number of ED visits attributable to adverse events associated with supplements we identified is likely to be underestimated because patient use of supplements is underreported, and physicians might not recognize adverse events associated with supplements as frequently as they recognize adverse events associated with medications. Clinicians may also have a limited understanding of interactions between prescription medications and dietary supplements compared to interactions between prescription medications. The number of emergency department visits attributed to supplement-related adverse events that we identified is probably an underestimation, since supplement use is underreported by patients, and physicians may not identify adverse events associated with supplements as often as they do those associated with pharmaceuticals. Physicians also may have more limited knowledge of interactions between prescription drugs and dietary supplements than they do interactions between prescription drugs. Thus, disentangling effects of healthful dietary choices and lifestyle choices from dietary supplement use is generally not straightforward in epidemiologic studies. Randomized controlled trials are the best way to investigate supplement use and health outcomes, yet these tend to yield inconsistent results. In some cases, excess vitamin and mineral intake can be detrimental or produce undesirable side effects; thus, maximal levels are needed to assure safe supplement use.

Dietary supplements were used by approximately half of adults (49%), in 2007-2010, though that was somewhat lower than 2003-2006 (53%). Dietary supplements are defined under law as products intended to complement the diet; they are not medicines, and thus are not intended to prevent, diagnose, treat, alleviate, or cure diseases. Less than one-fourth of supplements used by adults were recommended by a doctor or healthcare professional. About one-quarter (23%) of supplements were reported as being used at the recommendation of a health care professional.

Physicians and health professionals were most likely to recommend using a calcium supplement to women, and for heart health in men. Multivitamin-mineral products remain the most frequently reported type of supplement, mainly used for improving or maintaining health.

Over the following 50 years, efforts were made to enact several regulations that would regulate food additives, including the definition of nutrients as necessary and significant, establishing minimum and maximum limits of nutrients that could be added to products according to their recommended dietary allowances (RDAs), designating products that contained more than 150% of RDAs asdrug-like supplements, and placing limits on the claims made for health effects (Swann 2016). The Act classified many OTC food and nutrition products as foods, not drugs. The version that became law was passed as a result of industry misleading many of its customers to believe the FDA intended to severely limit sales of supplement products.

The FDA is not liable for dangerous products until after they hit the market, so the agency cannot act on the regulation until the contaminated or mislabeled product is likely in a consumers hands. The Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546), passed in December 2006, requires manufacturers of dietary supplements and nonprescription drugs to inform FDA about serious adverse events associated with their products. The FDA may take action against companies making false or unreasonable claims in order to market their supplements.

The regulators ability to carry out its mission successfully is hindered by the vast amount of products and manufacturing facilities, as well as a lack of analytical methods for all ingredients and products on the market, which is particularly challenging with respect to plant-based, herbal supplements. Now, this is further complicated by the fact that the FDA has many sitting bureaucrats that detest dietary supplements and who would like to see a premarket approval, this will push out of sight the costs for vitamins, minerals, even herbal products. Many misleading claims would be banned, supplement strengths would become more standardized, and dosages above a half-time of your recommended daily allowance (RDA) would be regulated as anover-the-counter medicine.

Many supplements have at least one food component, such as vitamins, minerals, herbs, botanicals, amino acids, or enzymes. These only apply to supplements containing vitamins and/or minerals, in which those products are regulated as foods, and they cover supplement composition, including safety, purity, and bioavailability.