Dietary Supplements: Manufacture to Market
The Food Journal
April 1, 2013
- It takes a fair amount of scrutiny to understand where the guidelines for supplements are synonymous between the Food Safety Modernization Act of 2011's New Dietary Ingredients and the Federal Food, Drug and Cosmetics Act regarding food additives. The FDA issued a document called "New Dietary Ingredients and Food Additives: What they have in common" for clarification. The Modernization Act required new and existing brands of dietary supplements to notify the FDA should the supplement contain a dietary ingredient not marketed as a dietary supplement before October 15, 1994, even if they have been safely used in the market place for years. The Federal Food, Drug and Cosmetics Act states any substance that is intentionally added to food is a food additive, subject to pre-market review and approval by FDA, unless the substance is generally recognized among qualified experts (see the Generally Recognized as Safe (GRAS) provision) as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.
- After Congress passed the Nutrition Labeling and Education Act (NLEA) in 1990, the supplement industry got nervous because NLEA regulated health claims for food. The supplement industry was concerned that supplements may be regulated next and the DSHEA regulations were approved. Supplements can be put on the market without providing proof to FDA of effectiveness or safety (as prescription drugs need to do), and manufacturers can make claims called structure-function claims, circumventing the health claim limitations NLEA imposed on food. The subliminal message of structure/function claims is that it prevents or treats disease even though the language is not specific to prevention or treatment of disease. Structure/function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. The Office of the Inspector General of the US Department of Health and Human Services orchestrated a study in 2012 and determined that "Dietary supplement Structure/Function claims fail to meet Federal requirements."
- The Standards of Supplements: There are three FDA grades for supplements: Pharmaceutical grades (meets pharmaceutical standards), food grade (meets standards set for human consumption) and feed grade (meets standards set for animal consumption). The problem is that The Food and Drug Administration has standards for Good Manufacturing Practices but do not actively certify or regulate the standing of supplement grades. Supplement manufacturers can certify through a third party that help product producers comply with the Food Safety Modernization Act and other governmental regulations regarding herbal and dietary supplements.
- The Recommended Daily Allowances (RDA) for food and supplements do not use common language. RDAs are based on sex and age. Supplements have no stated Daily Value. Therefore the RDA for supplements is based on one value for each nutrient, known as the Daily Value (DV), selected for the labels of dietary supplements and foods. A DV is often, but not always, similar to one's RDA or AI for that nutrient. The FDA had to select one standard for labeling purposes. Therefore, they developed the Daily Values (DVs) for nutritional labeling. They are based on the 1968 RDAs. Usually the Daily Value used was the Allowance for adolescent males but that was not across the board. According to the Office of Dietary Supplements of the National Institute of Health, "DVs were developed by the U.S. Food and Drug Administration (FDA) to help consumers determine the level of various nutrients in a standard serving of food in relation to their approximate requirement for it."
- If consumers are turning to both certain foods and dietary supplements in order to be healthier, supermarkets need to be aware of the benefits for their customers and that the oversight for supplements is different than the foods and products in their pharmacies. Consumers have to report an adverse event, which means the FDA probably only knows a small percentage of adverse events that occur. It is after dietary supplements are on the market that the FDA evaluates their safety through research and adverse event monitoring. According to the SAER Law, the FDA recommends that all supplement products bear either a domestic phone number or address on the product label so consumers can more easily report adverse events. The FDA also provides a list of Tainted Supplements.
The Government Process of Supplement Regulation and the role of the FTC:
The Dietary Supplement and Health and Education Act of 1994 gives the FDA the authority over supplement regulation. But they don't approve supplements. The National Institute of Health site has this to say: "While the supplement company is responsible for having evidence that their products are safe and the label claims are truthful and not misleading, they do not have to provide that evidence to the FDA before the product is marketed." The way the FTC is primarily in charge of overseeing claims is in advertising including print and broadcast ads, catalogues, informercials and similar direct marketing materials. Since the DSHEA weakened the FDA's authority to ensure efficacy and safety of supplements by removing supplements categorically from drugs, the FTC has gotten more vigilant in its dissemination of information. Strauss commentary If a supplement is adulterated, the Secretary of Health and Human Services also comes into play here. According to an October 8th, 2002 testimony by the Deputy Commissioner of the Food and Drug Administration, "Under DSHEA, a dietary supplement is adulterated if, among other things, it or any of its ingredients presents 'a significant or unreasonable risk of illness or injury' when used as directed on the label, or under normal conditions of use if there are no directions." The FDA bears the burden of proof to show that a product or ingredient presents such a risk. In addition, the Secretary of Health and Human Services (HHS)has the authority to declare that a dietary supplement or dietary ingredient poses an "imminent hazard" to public health or safety." Herbalife's John Venardos and Mark LeDoux of National Alternatives Intl., created a slide show at Focus on the Future to help producers understand.
What it takes to get a product removed:
One of the most serious differences in the way foods and supplements are managed at retail has to do with product recalls. According to the report Death by Dietary Supplement by Henry Miller of the Hoover Institution, "The U.S. Congress has virtually exempted herbal remedies from government oversight." The FDA posts on its web site, "The FDA does not approve dietary supplements before they reach the consumer." A Consumer Reports article tells of the FDA receiving seven reports of serious health problems regarding consumers who took Soladek vitamin solution, marketed by Indo Pharma of the Dominican Republic. "When the FDA learned that tested samples contained vitamins A and D at concentrations many times the recommended daily allowances, it issued a consumer warning. Why not simply order a problem product off the market?" The article goes on to say that current laws make it so difficult for the FDA to take products off the market that to date it has banned only one ingredient, ephedrine alkaloids. That effort dragged on for a decade, during whichephedra weight-loss products were implicated in thousands of adverse events, including deaths. Energy drinks are categorized as dietary supplements. "We don't have energy drinks defined by any regulation," Daniel Fabricant, director of the F.D.A.'s dietary supplement division, acknowledged in an interview in October.
The Younger Generation: Supplements for children:
Increasingly parents are looking to supplement their children's diets if they believe they are not getting enough nutrients through their normal diet. According to the American Academy of Pediatrics (AAP), "As much as possible, try to maximize the vitamins your child receives in her regular meals." Their site then lists vitamins and minerals necessary for normally growing children, and some of the foods that contain them. In 2008, AAP doubled the recommended daily intake of vitamin D for infants and children from 200 IU/day (2003 recommendation) to 400 IU/day. The study went on to find that about 25% of breastfed infants did not meet the new recommendation without supplementation. Therefore, supplementation with vitamin D is recommended for fully breastfeeding or mostly breastfeeding infants. So breastfeeding mothers, as well as parents with their finicky eaters, turn to supplements worried their children will not get the essential vitamins and minerals such as vitamin A, B vitamins, C and D and Iron. The question is if there is not an accurate daily value for all nutrients, then how do you determine what is right for your child? The Food and Nutrition Board, Institute of Medicine, National Academies provides Dietary Reference Intakes. Parents can check the Reference Intake for their child's age and sex on the web site as well asTolerable Upper Intake, a level considered the maximum daily allowance for safety. This is not a concern with daily multi-vitamin/mineral supplements, but supplements of individual nutrients are often megadoses that may be of concern for children because children have smaller bodies than adults. Children can also be attracted by colored and flavored supplements. Parents need to be careful to keep all supplements and medications out of their children's reach.
The Position of the Grocer:
Supermarkets offer a wide array of supplements for their customers who want health-related options. The supplement may take up less square shelf footage and bring more revenue per square foot and therefore be an attractive addition to the product mix. Selling supplements enables the grocer to sell a greater variety of products, increase basket size and reduce the need for the shopper to go elsewhere for the additional items. Recent studies such as the one presented in 2012 at the Institute of Food Technologists' Wellness meeting says "more consumers favor getting their vitamins and minerals from the foods they eat and beverages they drink instead of supplements." Where there are retail dietitians or in-house nutritional experts, they can direct people to the right foods, help them read labels and work with them on their specific health needs. Pharmacists in the same store may be directing the same customers towards supplements. Demery commentary The Council for Responsible Nutrition has prepared a six-page outreach for retail on the subject of consumer dialogue about supplements which may be helpful. Furthermore, on the Council for Responsible Nutrition web site information can be found on its strong programs on self-regulation and proactive policy agendas in this area. Supermarket web sites have become more robust on health and wellness. Enhancing the information on supplements and their value can aid their consumer with his or her options. The FDA web site provides name searches for supplements to see its history. FDA's Center for Food Safety and Applied Nutrition (CFSAN) has a wealth of educational materials that make it easy to understand and use the Nutrition Facts Label. The FDA also has its own You Tube channel. The US Department of Health and Human Services directs consumers to helpful sites.
Earlier this year, the FDA called for public comment on the paperwork burdens from manufacturers of supplements reporting to the FDA within 30 days of the first marketing any and all statements on the labels. Lempert commentary