In the previous post entitled “US Food Law and Regulation Series: Part 1”, we focused our discussion on the different regulatory body FDA, USDA, CDC, NMFS, EPA, DHS etc and their interaction in the food safety regulation. In the second part of the series entitled “US Food Law and Regulation Series: Part 2”, we tried to discuss the issues in the definition of food, dietary supplements and drug. We also discussed the concept of “intended use” and how it can have impact on the definition.
This is the third part of the series. In this post, we will shortly discuss the EU and Japanese system of regulation of dietary supplement. However, our main focus will be the regulatory mechanism of dietary supplement in USA. The history of FDA with dietary supplement is the learning for the entire world. The issues and challenges faced by FDA, court decisions, background and the driving force for the development of a separate dietary supplement regulation will be discussed chronologically.
Let’s start with EU and Japanese system.
European Food Safety Authority uses a term food supplements. European Union (EU) has analogous regulatory system compared to US. The main dietary regulation is found in 2002 EU directive, Directive 2002/46/EC. It has a list of permitted vitamin and mineral components for specific intended uses. The regulation 1924/2006 related to nutrition and health claims was adopted in 2006 and it demands the verification for substantiation and approval for the claims.
In Japan, all the supplements are treated as food. Yet it offers the most restrictive regulation of dietary supplements. Supplements are categorized into 4 categories: Food for special dietary uses; Food for specified health uses; Health foods; and Health foods with nutrient function claims. The structure/function claims are not allowed and only the few health claims are allowed in certain supplements.

The details of the discussion on EU and Japanese regulatory systems have been skipped for the moment to focus our discussion on history of regulation of dietary supplement in USA.
Regulation of dietary supplement by US FDA
Let's start our discussion chronologically starting form the beginning of 19th century.
In the past, only a small number of ingredients (usually common food constituents) were used as supplement. Cod liver oil having vitamins A and D is probably the first dietary supplement in USA. The 1906 Act provided the first distinction between food and drug, however the regulation of both products were identical. The classification was mainly based on active molecules and the packaging claim.
With increasing public interest in vitamin supplements, FDA started working in the vitamin claims and established a Vitamin Division in 1935. It also started working on new ingredients/ compounds with claimed health benefits. FDA filed a criminal case against a vitamin product containing milk, sugar, wheat starch and vitamins with health claims of curing high blood pressure, low blood pressure, dropsy, toxic goiter, and heart disease. It was probably the first attempt to take legal action against the vitamin product with disease claims in USA. The FDA experience with such case did influence and shape the upcoming regulation in the field of dietary supplement. The 1938 act provided authority to FDA for the regulation of supplement type products having labeling of “food for special dietary uses” under the misbranding provisions. Three groups of foods were initially focused in the regulation under the 1938 act: (1) “staple foods fortified with vitamins and minerals” were regulated with standards of identities, limits on the amount of nutritional ingredients and barring any health claims; (2) “foods for special dietary uses” (e.g. infant foods and foods for diabetics ); (3) dietary supplements were regulated either as conventional food or food for special dietary purposes. In the early days, parenteral supplements, despite not having labeling of disease claims, were exclusively regulated as drugs. Nevertheless, the products with an intended use to supplement the daily diet were regulated as foods.
This approach didn’t work well to regulate claims on vitamins, minerals and dietary supplements, as regulations for special dietary food was not designed in that way. In a series of court case between FDA and different manufacturers (such as Nutrilite, Abbott, Dextra, Vitasafe, Nutrilab) the concept and classification of dietary supplement emerged. Among them the most significant case was the one that of Nutrilab. The court decided that “intended use” could be the greatest tool to classify supplements. FDA was allowed to classify the product with alleged disease claims or medicinal use as drugs, and should pass through premarket clearance. On the other hand, FDA should regulate the dietary supplements without claims or with nutritional claims as food.
FDA attempted to issue a separate regulation for dietary supplements in 1962 with a set dosage levels of supplements. FDA proposed to permit a single nutrient dietary supplement with levels close to US Recommended Daily Allowance (RDA), while limiting the number of multivitamin and mineral products. The proposed regulation was to classify the “high potency” dietary supplements as drug, which created a series of spark and outcry. FDA eventually needed to drop its proposal. Afterwards, Congress attempted to regulate vitamins and minerals with therapeutic claims using “Vitamin and Mineral Amendment of 1976”. This was the first specific attempt to address dietary supplements by stopping the FDA to regulate threshold based “high potency” dietary supplement as drug. However, the scope of the legislation was narrow for regulating different dietary supplement products. FDA continued its attempt to regulate number of supplements using drug regulations.
In 1990, nutrient content and other claims for food were established in Nutritional Labeling and Education Act (NELA). It established the concept of nutritional labeling. NELA made it mandatory to declare any vitamin and mineral supplementation in the label. It also opened the door for health claims for dietary supplements to make certain claims about the benefits of nutrients it contained. It allowed the established claims related to the reduced risk of disease or health conditions. However, a general dietary guidance (such as fruits and vegetables as part of healthy diet) is not considered a health claim. FDA was authorized to review and approve the health claims using the criteria set by NLEA. FDA needed to conduct an exhaustive review of scientific literatures to obtain “significant scientific agreement” on the health claims. Only the FDA approved health claims were allowed.
The history of L-tryptophan regulation by FDA should be remembered here. FDA was concerned with an supplement ingredient L-tryptophan (an amino acid) over the adverse health effect of eosinophilla myalgia syndrome. FDA issued a consumer advisory warning to the public about that supplement and established a task force to examine. That task force recommended the FDA to regulate that supplement as drug, without considering the possibility of health claims under NELA. It was ultimately considered an aggressive enforcement approach of FDA by different experts and law makers.
The era of confusion on the regulation of dietary supplements ranged from 1906 till 1994. A rapidly growing market with unscrupulous claims of dietary supplements was an increasing challenge for FDA. Even judiciary struggled to develop consistent interpretation of the act in the field of dietary supplements. It ultimately demanded for the Dietary Supplement Health and Education Act (DSHEA) of 1994. Congress passed DSHEA to restrict FDA ability to impose unnecessary control on dietary supplements, because of unrealistic and aggressive enforcement of FDA in the case of L-tryptophan case. Enactment of DSHEA was a ground breaking step in the regulation of dietary supplement. It established a framework for new Good Manufacturing Practices (GMPs) for the dietary supplement industries.
DSHEA also widened the definition of dietary supplement and included a wide range of products consumed orally. It included functional ingredients that supplement diet but excluded the adjuncts such as fillers, preservatives, emulsifiers, additives etc. It became mandatory for the product to be labeled as “dietary supplement” so as not to be misinterpreted as conventional foods. However, misinterpretation for liquid dietary supplements such as energy drinks remained an issue. FDA issued “Distinguishing Liquid Dietary Supplements from Beverages” guidance document explaining criteria in evaluating intended use (such as product name, packaging, serving size, total recommended daily intake, composition, recommendations and directions for use, statements and representations in labeling or advertising etc).
Enactment of DESHA established dietary supplement as a special category of food, separating from drug regulation. Unlike the requirement of assessment of drug prior to entering market, the new regulation allowed dietary supplement to be treated as food and provided easy access to the market. The burden of finding the quality and safety issues in the supplement was kept on the agency. FDA is actively monitoring and enforcing the regulation by taking legal actions such as recall, consumer notice, criminal court case etc
FDA mainly carries out post market enforcement approach for dietary supplements focusing on adulteration. A 75 day pre-market notification to FDA is needed only for the supplements having "new dietary ingredients". The burden of proving the safety of a new ingredient lies with manufacturer. It is mainly based on two criteria: (1) All new dietary ingredients in the product stays without chemical alteration; (2) All new dietary ingredients should be safe when used under the label recommended conditions (e.g. complies with the GRAS (Generally Regarded As Safe) criteria used in assessing food additives). The safety evaluation should take into consideration of the level of usage, intended use, toxicological information etc? Failure to fulfill the requirements could deem the product adulterated. In addition, if a dietary supplement contains added substance that is injurious to health under the recommended conditions, they are also deemed adulterated.
As discussed earlier, NELA had provided only a narrow legislative space for claims. DSHEA also widened the claims related to dietary supplements. It allowed structure/function claims, general well-being claims, and also the claims related to the classical nutrient deficiency diseases. However, these claims should bear the disclaimer stating “FDA has not evaluated the claim”. It also created a mandatory provision that manufacturer must notify the FDA within 30 days of marketing the products containing one of these claims. The rule defining the structure function claims was enacted four years later by FDA. It provided guidelines to distinguish structure function claims from the disease claims (such as claims containing “diagnoses, treats, prevents, cures, or mitigates disease”). The symptoms strongly associated with a disease or health conditions were also deemed disease claims. For example, joint pain or inflammation is strongly linked to arthritis and using the terms is equivalent as using the name of disease.
FDA enforces the advertising of dietary supplements together with Federal Trade Commission (FTC) as per the working agreement between the agencies. FDA regulates the labeling and FTC regulates over advertising and marketing of dietary supplements. Therefore, misbranding and label claims are the domain of FDA. FTC and FDA are collaborating in the evaluation of promotional language in advertising and websites and are enforcing the regulation together.
Summary
Dietary supplements, with no therapeutic claims, were generally regulated as food in the past. However, there were series of issues, legal tussles and court cases between FDA and manufacturers regarding the regulation of dietary supplements. In number of cases, FDA tried to regulate dietary supplements as drugs, but they failed to prove in court. The history also suggested number of cases when manufacturers tried to market drug products in the name of dietary supplements. Even though FDA was a single agency regulating both food and drug products, the confusion on the regulation of dietary supplements existed in the past. This era of confusion on the regulation of dietary supplements ranged from 1906 till 1994. Ultimately, the enactment of "Dietary Supplement Health and Education Act (DSHEA)" in 1994 was a ground breaking effort in the regulation of dietary supplements in USA. This act gave an independent identity to the dietary supplements and forced FDA to regulate them like foods.
Lessons Learnt
From the above discussion, we should have an idea on the history of the regulation of dietary supplements. It explains why and how dietary supplement has proved to be the domain of National Food Control Authority. The ambiguity of food, food supplement and drug existed for a century in USA until DSHEA was formulated. The world has already learnt the lesson from this history. We should also try to learn from their experience. The history has clearly demonstrated that the ambiguity of regulation of dietary supplement cannot be solved just by merging the food and drug control agencies into a single FDA system. If so, US FDA would not have faced all those problems in the history. It is more important that specific definition, condition or criteria are set for a clear classification of food, drug and dietary supplements. The concept of “intended use” and the label claims by the manufacture are the important criteria for classification. Food and drug are two different domains of health, having different regulatory requirements. They can be independently run by different organizations and not necessarily by a single FDA like organization. It does not mean that designing a single food and drug control agency is totally wrong. There is possibility of harmonization, collaboration, cooperation, efficiency in working etc. There could be number of benefits and also the number of challenges. Sometimes, having too many regulatory power in a single agency can make it autocratic and could be used in political interest. We might need to carry out SWOT (Strength, Weakness, Opportunity and Threat) analysis for different options. Let's leave this discussion for the experts. Nevertheless, based on our discussion in this post, we probably can conclude that "the history does not seem to support the requirement of a single FDA agency just for the sake of regulating the dietary supplements".
Let's not forget the famous quotes:
“Don’t forget the past, learn from it”.
“Let's learn from the mistakes of others, you can never live long enough to make them all yourself.”
……………….end of part 3
I will try to continue this series. Please provide your feedback in the comment box below. You are free to agree or disagree with my argument.
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Related post to read
US Food Law and Regulation Series: Part 1
US Food Law and Regulation Series: Part 2
References
M. C. Sanchez, Food Law and Regulation for Non-Lawyers, Food Science Text Series, DOI 10.1007/978-3-319-12472-8_2, © Springer International Publishing Switzerland 2015
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