Harvey Wiley: Birth of Food (and Supplement) Regulation in the U.S.
The history of food and dietary supplement regulation began with Dr. Harvey Washington Wiley, who is affectionately known as the “Father of the FDA”. Dr. Wiley was born in a log cabin in 1844 on a frontier farm in Kent, Indiana. Wiley spent his early years helping to plant and harvest crops on his family farm. He studied at Hanover College starting in 1863 until he enlisted with the Union Army with the Indiana Volunteers. He returned to Hanover College and received a Masters of Arts. Wiley received a medical degree at Indiana Medical College in 1871 and a bachelor’s degree at Harvard in 1873. By his late 30s, he was a professor of chemistry at Purdue University, beginning in 1874.
In 1883, Dr. Wiley was persuaded to give up academic life and move to Washington, D.C. as chief chemist in what is now the Department of Agriculture. His main task was to support the new agricultural industries, but he was able to continue his pursuits to develop new standards and tests for food purity.
Over the next 2 decades, pure-food bills were introduced into Congress, largely based upon his work, but not one was enacted into law. Wiley would organize out of frustration, the Poison Squad, a volunteer group of healthy young men, in 1902 to test the effects of chemical and adulterated foods on themselves.
His efforts culminated in a victory when President Theodore Roosevelt signed the Pure Food and Drugs Act, largely written by Dr. Wiley, into law in 1906. Dr. Wiley was also appointed to oversee its administration. Wiley went after snake oils, carpetbaggers making cure-all elixirs, and a variety of consumer products with unsubstantiated claims. Wiley advocated that chemical preservatives should be used in food only when necessary, that the onus of safety should be on the producer of foods, and that consumers should be informed about ingredients on food labels, the basic elements of current food and supplement laws and regulations today.
Wiley would leave government in 1912 and create the Bureau of Foods, Sanitation, and Health for Good Housekeeping. There he would continue to develop standards at the Good Housekeeping Institute laboratories in Washington, DC. Dr. Wiley led the fight for tougher government inspection of meat; for pure butter unadulterated with water; and for whole wheat flour. The Bureau’s third-party “Tested and Approved” seal became the coveted symbol of responsible industry.
Wiley was also involved in exposing obesity cure-all products with unsubstantiated claims, ranging the spectrum from misleading to fraudulent. He campaigned for reforms in food manufacturing and labeling throughout his career. He also contributed to the passage of the Maternity Bill, which allocated Federal Funds for improved infant care, ultimately resulting in a reduction of the infant mortality rate. Wiley was also a founding father of the Association of Official Analytical Chemists.
Creation of the Pure Food and Drugs Act
The original Pure Food and Drugs Act, passed by Congress on June 30, 1906, was enforced by the Agriculture Department’s Bureau of Chemistry. The law prohibited the introduction of misbranded and adulterated foods, drinks, and drugs into interstate commerce; prohibited the addition of color additives to conceal inferiority; and prohibited the use of “poisonous” colors in confectionary. Other federal legislation followed the Pure Food and Drugs Act, including the Food Inspection Decision 76, which listed seven colors approved for use in food.
In 1913, the Gould Amendment, which required that contents be plainly marked on the outside of the food package, was added to the 1906 Pure Food and Drugs Act. A pivotal court ruling in 1914 placed the responsibility on government to show a relationship between a chemical additive and any harm it allegedly caused in humans.
While a Supreme Court ruling in 1924 upheld the 1906 Pure Food and Drugs Act provision to prohibit information on product labels that could mislead or deceive consumers, the Pure Food and Drugs Act was not bulletproof.
Food, Drug, and Cosmetic Act of 1938
In 1930, the Bureau of Chemistry became the Food and Drug Administration. In 1933, the new FDA recommended a complete revision of the 1906 Pure Food and Drugs Act, launching a 5-year battle in Congress. While FDA sought a fast replacement, it was not until the sulfanilamide scandal, responsible for 107 deaths in 1937, that Congress would pass the Food, Drug, and Cosmetic (FD&C Act) in 1938. The FD&C Act gave FDA a whole new set of provisions and authorities in 1938. The FD&C Act extended regulatory control to cosmetics for the first time, in response to concerns about cosmetic safety. The new Act required that colors be listed (approved) before they could be used in foods, drugs, and cosmetics.
A food could be considered misbranded or illegal it they represented itself as a standardized food unless it conformed to that standard. The FD&C Act authorized three kinds of food standards, based upon identity, quality, and fill of container. The first standards issued were for canned tomatoes, tomato puree, and tomato paste in 1939. By 1957, standards were set for a wide variety of foods such as chocolate, flour, cereals, bakery products, milk, cheese, juices, and eggs.
Amendments for Food and Color Additives
In 1950, the Delaney Committee started a congressional investigation of the safety of additives that laid the foundation for the Food Additives Amendment and the Color Additive Amendments. Rep. James Delaney (D-NY) inserted the “Delaney Clause,” which prohibits the approval of any food additive shown to induce cancer in humans or animals in studies with a relevant route of exposure. Variations of the Delaney Clause were also included in the Color Additive Amendments and animal drug provisions.
The Food Additives Amendment, enacted in 1958, required manufacturers of new food additives to establish their safety to FDA’s satisfaction before marketing. Food additives are substances that have no proven track record or safety and therefore must be approved by FDA before they can be used in human food. A food substance generally recognized by qualified experts as safe (GRAS) for its intended use, based on publicly available information, was excluded from the definition of food additive. The FDA first published a list of these GRAS substances in the Federal Register of December 9, 1958. This GRAS list, as it is still referred to today, contained nearly 200 substances including ascorbic acid (Vitamin C), papain (a dietary ingredient for use in dietary supplements), and propylene glycol. The GRAS review process became a major project at FDA”s former Bureau of Foods (now the Center for Food Safety and Applied Nutrition).
The Color Additive Amendments, enacted in 1960, defined “color additive” for the first time and required manufacturers to establish the safety of color additives prior to their use in coloring foods, drugs, cosmetics, and medical devices. Under the 1960 Amendments, all the color additives were put on a provisional list for use on an interim basis pending evaluation by the FDA. The agency subsequently began permanently listing in the Code of Federal Regulations (CFR) those color additives for which scientific data established their safety. Today, about half of the original 200 color additives are permanently listed for use in foods, drugs, cosmetics, and medical devices.
The Fair Packaging and Labeling Act
In 1966, the Fair Packaging and Labeling Act required products marketed on a retail basis to consumers and placed into interstate commerce to be honestly and informatively labeled. The Fair Packaging and Labeling Act (FPLA) enacted in 1967, directs the Federal Trade Commission (FTC and the FDA to issue regulations requiring that all “consumer commodities” be labeled to disclose net contents (21 CFR 101.105) in both metric and inch/pound units, statement of identity of the commodity (21 CFR 101.3), and the name and place of the business of the product’s manufacturer, packer, or distributor (21 CFR 101.5). The FPLA authorizes additional regulations to prevent consumer deception or to facilitate value comparisons with respect to descriptions of ingredients, slack fill of packages, use of “cents-off” or lower price labeling, or characterization of package sizes.
Regulation of Vitamins and Minerals (Dietary Ingredients in Dietary Supplements) as Food
Once the FD&C Act was passed in 1938, FDA established detailed labeling requirements for foods marketed for “special dietary uses.” These rules remained in effect until 1962 when FDA published regulations proposing to set minimum and maximum levels for dietary supplements (including vitamins and minerals), but withdrew them in the face of consumer protest. The 1960s was as tumultuous in federal regulation for vitamins and minerals as it was for American culture in general. FDA spent that decade pondering about what to do about vitamins, minerals, and other dietary supplements. FDA would propose the Vitamin and Mineral Regulation of 1966 and make it official in 1973. The regulation attempted to declare that future regulations would ban all mention of dietary supplement sources, whether natural or synthetic. NNFA (today NPA) fought to allow industry to declare on labels the substance origin for a dietary supplements. FDA also wanted to place a ban on all statements and claims made on health food supplement labels. This sparked the Vitamin Hearings of the late 60s and early 70s.
The FDA Commissioner wanted to set limits on vitamins without any basis because they believed many vitamins and minerals, including vitamin E and zinc, were not essential to the human diet whatsoever. Today, FDA recognizes 28 vitamins and minerals and has established recommended daily intake or allowance levels through science for those dietary ingredients. FDA also tried to limit the potency, number, and variety of combinations of ingredients in food supplements.
In 1975, FDA’s and FTC’s bans on categories of claims was challenged by NNFA (NPA) even if the claim was truthful and not misleading. On August, 15, 1975, affectionately termed VS Day or “Victory for Supplements Day”, NPA won this monumental challenge as the Court of Appeals ruled in the favor of industry. The Judge also permitted use of the word “natural” in labeling, another failed attempt by FDA to control commercial speech. FDA could also no longer impose potency bans on supplements with ingredients in excess of 150% of the recommended daily allowance and therefore could not impose recommended daily allowances as the basis of an upper ceiling limit for ingredients in supplements. Non-essential nutrients could also be listed on supplement products.
Recognizing FDA’s treatment of vitamins, minerals, and nutrients as drugs in the 70s, Congress passed the 1976 Proxmire Bill, which became the Rogers Proxmire Act. This prohibited FDA from regulating vitamins and minerals as prescription drugs. Vitamins, minerals, nutrients, and dietary ingredients used in supplements would be forever regulated as foods. While FDA continued their fight the following year to classify vitamins A and D in high dosages as drugs, NNFA (NPA) won this challenge in the 2nd Circuit Court (NNFA v Mathews, 1977).
Conventional Foods and Dietary Supplement Labels Become Standardized
There was no uniform standard of labeling for conventional foods and dietary supplements up until 1990, so the Nutrition Labeling and Education Act (NLEA) was passed by Congress that year to require most packaged foods to bear nutrition labeling. NLEA standardized food nutrition information on labels serving sizes; terms for “low fat,” “light,” and other nutrient content claims; declarations on the amount of nutrients, vitamins, or minerals present; and information relating to those substances. NLEA also provided for health claims, and FDA created a standard of “significant scientific agreement” to decide when a food could make a health claim.
A one-year delay or moratorium was passed by Congress and placed on the implementation of NLEA provisions to dietary supplements in 1992. The preceding year, FDA created a Task Force to once again look at whether dietary supplements should be regulated as drugs as they did in the 1970s. FDA was concerned over labels with unsubstantiated claims of health benefits, and their enforcement solution was to regulate all botanical dietary ingredients as unapproved food additives rather than on the basis of a safety concern throughout the 80s and early 90s.
DSHEA Creates the Regulatory Category of “Dietary Supplements”
Congress would pass the Dietary Supplement Health and Education Act of 1994 unanimously. A U.S. Senate report on DSHEA argued that “FDA has tried to ‘protect’ the public against ‘unsafe’ products for which there is no evidence that the product is unsafe,” while acting to “restrict the information that the public may receive about dietary supplements.” (S. Rep. No. 103-410, at 16). DSHEA struck a balance between increased consumer access to dietary supplements and the development of new, strict standards of quality and safety for dietary supplements. DSHEA defined the term “dietary supplement” for the first time as well as the types of ingredients that could and could not be dietary ingredients for use in dietary supplements. It created new specific labeling requirements for dietary supplements which parallel those for conventional foods. DSHEA provided a new regulatory framework and shifted the burden of proof about a dietary supplement product’s safety from the manufacturer to FDA. FDA could no longer enforce against dietary supplements based upon a whim. DSHEA also authorized FDA
Structure Function Claims Unique to Dietary Supplements
Congress authorized FDA in DSHEA to define a new type of claim. These new types of “statements for nutritional support” would describe the effect of supplements or an ingredient contained in the supplement on the structure or function of the body. The Structure Function Final Rule was written exclusively to regulate statements made on dietary supplements, and disease claims would not be permitted as structure function claims. This rule prevented any company from making claims to cure, treat, prevent, or mitigate diseases on their products even if it was truthful, not misleading, and backed by competent and reliable scientific evidence. It was not until their January 6, 2000 structure function final rule on dietary supplements that FDA defined the term “disease” and the universe of claims that would be considered unpermitted disease claims. The final rule never defined what a good structure function claim looked like. While all claims must be truthful and not misleading, the structure function final rule states that dietary supplements must have substantiation for the structure function claims made on labels, labeling, and advertising. The FTC standard of “competent and reliable scientific evidence” would be applied to any dietary supplement products making claims. FTC possesses subpoena power to ask for any substantiation evidence a company uses as the basis of the particular claim they are making.
Good Manufacturing Practices (GMP) for Dietary Supplements
DSHEA also granted FDA powers to develop manufacturing standards for dietary supplements. GMPs are designed to ensure supplement quality and speaks to standards set for identity, strength, purity, and composition, as well as testing for contaminants and heavy metals. Since the FDA did not address GMPs or quality in supplements after Congress gave them powers to do so, the NNFA (NPA) stepped in to help develop a model for dietary supplement good manufacturing practices and quality. It was patterned after the drug GMPs and served as the basis for FDA’s Advanced Notice of Public Rulemaking on the much anticipated dietary supplement GMP proposed rule. The rule addressed testing for identity, strength, purity, composition, and limits on contaminants; procedures to prevent mistakes with ingredients; testing incoming ingredients, in-process materials, and final products; mislabeling; and improper packaging. FDA would pass the dietary supplement current GMP final rule in 2007. FDA would begin inspecting domestic firms and foreign companies importing finished dietary supplement products into the U.S. starting in 2008. FDA average approximately between 600 and 700 domestic inspections of dietary supplement manufacturers and own label distributors annually.
New Dietary Ingredient Pre-Market Gate
DSHEA also implemented a pre-market gate for any dietary ingredients that were not in commerce before October 15, 1994. If a dietary ingredient was “new” and was never before in commerce, manufacturers and distributors must submit a New Dietary Ingredient dossier to FDA which contains the basis for reasonable expectation of safety. The dossier should contain identity and safety information unique to a company’s dietary ingredient.
Food and Drug Modernization Act and Health Claims
In 1997, Congress passed the Food and Drug Modernization Act which allowed dietary supplements to make health claims, as long as companies provided evidence that adhered to FDA’s SSA. This requirement asks industry to provide two randomized controlled clinical trials to substantiate a health claim designed to look at disease risk reduction. Two Randomized Controlled Clinical Trials or RCTs is also known as the drug standard.
Qualified Health Claims
The years between 1999 and 2001 saw two major developments for dietary supplement regulations. First, case law in ‘Pearson v. Shalala’ forced the FDA to allow qualified health claims on products. Qualified health claims would be allowed when there was some scientific information available but not enough information to pass the 2 RCT rule as per the FDA’s SSA for health claims. Second, FDA revised the food labeling regulations to require dietary supplements to present nutrition information in a box with the title “Supplement Facts”.
New Requirements in the New Millennium
After the terrorist attacks on September 11, 2001, the FDA conducted food supply vulnerability assessments and received additional resources for strengthening its field staff of food inspectors and lab specialists. The Bioterrorism Act of 2002, signed into law by President George W. Bush, forced all food facilities, which includes dietary supplement companies, to register with the FDA, to provide FDA with prior notice of imported food shipments before food arrives in the U.S., and to keep records of their food sources and recipients for those who receive and distribute food in the U.S.
The Food Allergen Labeling and Consumer Protection Act or FALCPA, passed in 2004, established mandatory declarations for the eight most common allergens for packaged foods.
The Adverse Event Report (AER) Bill passed in 2006 ushering in the Dietary Supplement and Nonprescription Drug Consumer Protection Act for dietary supplements. This law requires dietary supplement manufacturers to report their serious adverse events to FDA and keep written records of all of their adverse events reported to them by consumers. Today, dietary supplements are the only commodity of food to have a mandatory reporting requirement for serious adverse event reports. Not even fish, meat and produce companies have to do that.
Food Safety Modernization Act (FSMA)
FSMA was signed into law in 2011 by President Barack Obama. That piece of legislation addressed problems in the supply chain (ingredients) predominantly from foreign overseas suppliers of ingredients in countries like China and India. While FDA’s preventive control rules for dietary ingredients contained in supplements are still being worked out, FDA is planning to increase its food inspection program related to FSMA initiatives.
Dietary Supplement Era of Enforcement
FDA has issued over 1,000 warning letters and led final agency enforcement actions like injunctions and seizures to prevent adulterated product from being sold on store shelves. FDA enforced so vigorously on dietary supplements between 2011 and 2014 that the dietary supplement group led the way on injunctions across all FDA groups for the first time ever.