The toxic tangle of American food, government, and culture...
QUALITY
Dietary supplements are complex products. The FDA has established quality standards for dietary supplements to help ensure their identity, purity, strength, and composition. These standards are designed to prevent the inclusion of the wrong ingredient, the addition of too much or too little of an ingredient, the possibility of contamination, and the improper packaging and labeling of a product. The FDA periodically inspects facilities that manufacture dietary supplements.
In addition, several independent organizations offer quality testing and allow products that pass these tests to display their seals of approval. These seals of approval provide assurance that the product was properly manufactured, contains the ingredients listed on the label, and does not contain harmful levels of contaminants. These seals of approval do not guarantee that a product is safe or effective.
Organizations that offer this quality testing include: U.S. Pharmacopeia, ConsumerLab.com, NSF International, and the Natural Products Association.
NIH OFFICE OF DIETARY SUPPLEMENTS, http://ods.od.nih.gov
Vitamins, Dietary Supplements, Quality Control and the FDA
The following is a 3-part interview of Al Czap by Tye Smit: The things you don't know about manufacturing and quality control from the CEO of Thorne Research and publisher of the peer reviewed medical Journal: Alternative Medicine Review.
Part 1 of 3
Part 2 of 3
Part 3 of 3
FEDERAL REGULATION OF DIETARY SUPPLEMENTS
The majority of adults in the United States take one or more dietary supplements either every day or occasionally. Today’s dietary supplements include vitamins, minerals, herbals and botanicals, amino acids, enzymes, and many other products. Dietary supplements come in a variety of forms: traditional tablets, capsules, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and E; minerals like calcium and iron; herbs such as echinacea and garlic; and specialty products like glucosamine, probiotics, and fish oils.
Dietary supplements are products intended to supplement the diet. They are not drugs and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The U.S. Food and Drug Administration (FDA) is the federal agency that oversees both dietary supplements and medicines.
In general, the FDA regulations for dietary supplements are different from those for prescription or over-the-counter drugs. Unlike drugs, which must be approved by the FDA before they can be marketed, dietary supplements do not require premarket review or approval by the FDA. 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.
Dietary supplement labels may carry certain types of health-related claims. Manufacturers are permitted to say, for example, that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (like immunity or heart health). Such a claim must be followed by the words, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Manufacturers must follow certain good manufacturing practices to ensure the identity, purity, strength, and composition of their products. If the FDA finds a product to be unsafe or otherwise unfit for human consumption, it may take enforcement action to remove the product from the marketplace or work with the manufacturer to voluntarily recall the product.
Also, once a dietary supplement is on the market, the FDA monitors information on the product’s label and package insert to make sure that information about the supplement’s content is accurate and that any claims made for the product are truthful and not misleading. The Federal Trade Commission, which polices product advertising, also requires all information about a dietary supplement product to be truthful and not misleading.
The federal government can take legal action against companies and Web sites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.
NIH OFFICE OF DIETARY SUPPLEMENTS, http://ods.od.nih.gov
"Robyn O'Brien's fervent message describes the toxic tangle of American food, government, and culture. THE UNHEALTHY TRUTH is a healthy dose of medicine that we all need to swallow, and I say this as an advocate for the environment, but more importantly, as a father of five." -Graydon Carter, Editor-in-chief, Vanity Fair
Real food, is that too much to ask? A former financial and food industry analyst, author, Fulbright grant recipient and mother of four, Robyn O’Brien brings compassion, insight and detailed analysis to her research on the health of the American families and its food system. She has been called "food's Erin Brockovich" by the New York Times.
Grounded in a successful Wall Street career that was more interested in food as good business than good-for-you, this mother of four was shaken awake by the dangerous allergic reaction of one of her children to a "typical" breakfast. Her mission to unearth the cause revealed more about the food industry than she could stomach, and impelled her to share her findings with others. http://www.robynobrien.com/
DIETARY SUPPLEMENTS
The U.S. Food and Drug Administration (FDA)regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). The Dietary Supplement Health and Education Act (DSHEA) became law in 1994; making the dietary supplement manufacturer responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.
FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. Manufacturers must make sure that product label information is truthful and not misleading. The Federal Trade Commission regulates dietary supplement advertising.
To be classified as a dietary supplement, as defined by Congress in the Dietary Supplement Health and Education Act of 1994, a product (other than tobacco) that is intended to supplement the diet; contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement. A new dietary ingredient is a dietary ingredient that was not sold in the United States in a dietary supplement before October 15, 1994.
Although dietary supplements are regulated by the FDA as foods, they are regulated differently from other foods and from drugs. Whether a product is classified as a dietary supplement, conventional food, or drug is based on its intended use. Most often, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in accompanying literature, although many food and dietary supplement product labels do not include this information.
The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements. The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim (http://www.cfsan.fda.gov/~dms/hclaims.html).
Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product. A structure/function claim is a statement describing how a product may affect the organs or systems of the body and it cannot mention any specific disease. Structure/function claims do not require FDA approval, but the manufacturer must provide FDA with the text of the claim within 30 days of putting the product on the market (http://www.cfsan.fda.gov/~dms/ds-labl.html#structure).
Product labels containing such claims must also include a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
In addition to regulating label claims, FDA regulates dietary supplements in other ways. Supplement ingredients sold in the United States before October 15, 1994, are not required to be reviewed by FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans. For a new dietary ingredient (one not sold as a dietary supplement before 1994) the manufacturer must notify FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product. FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons.
Manufacturers do not have to provide FDA with evidence that dietary supplements are effective or safe; however, they are not permitted to market unsafe or ineffective products. Once a dietary supplement is marketed, FDA has to prove that the product is not safe in order to restrict its use or remove it from the market. In contrast, before being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing evidence that it is both safe and effective. The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, The U.S. Food and Drug Administration may remove the product from the marketplace or take other appropriate actions.
NIH OFFICE OF DIETARY SUPPLEMENTS, http://ods.od.nih.gov/
