The dietary supplements industry has been given a final ruling by the FDA that requires it to comply with current good manufacturing practices (cGMP) to ensure its products are labelled accurately, are produced in a quality manner, and do not contain impurities or contaminants.
Commissioner of Food and Drugs, Dr Andrew C. von Eschenbach said that:
“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label.”
The regulations cover good practice in all stages of the product’s life cycle from manufacturing through packaging and labelling to storage. It covers testing of the finished product and the handling and recording of consumer complaints. And, as well as ongoing operations, the ruling covers the design and construction of manufacturing plants.
Recent changes in the law also means that the industry will have to report adverse events to the FDA:
“In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA,” said Eschenbach.
The Consumers Union welcome the new rule but say “it still does nothing to ensure that supplements are safe or effective before they go on the market”.
Janell Mayo Duncan, senior counsel for Consumers Union said that:
“This new rule requires dietary supplement makers follow procedures to ensure that their products contain the type and amount of ingredients on the label. However, consumers still have no idea if a given product works, or whether it is dangerous.”
Dietary supplements are not like prescription drugs; they do not have to prove they are safe and effective before consumers can buy them. Consumers buy dietary supplements for all sorts of reasons from boosting sport and athletic performance, to controlling weight and managing stress and anxiety.
Consumers Union has been lobbying Congress to bring in pre-market testing for safety and efficacy of dietary supplements and to give the FDA more powers to make manufacturers put known risks on the labels or to stop selling them if they do not comply with safety standards.
In a prepared statement the CU pointed out that last year Congress approved a measure they supported to require dietary supplement manufacturers and makers of over the counter drugs to tell the FDA of any “serious adverse events” linked to their products. Serious adverse events were defined as death, life- threatening, being admitted to hospital as an inpatient, disability, birth defect, and medical or surgical intervention.
The CU said that measure will help the FDA identify dietary supplements that may pose a serious threat to health, but the agency will not have the power to make the manufacturers show their product is safe before selling it to consumers.
Duncan said that it is still a case of “buyer beware for consumers of dietary supplements because manufacturers are not required to list known health risks for their products, or make sure that they are safe or effective”.
The FDA regulations will come into force on 24th August this year. Smaller businesses will have more time to implement the changes to their manufacturing, packaging, storage and labelling processes. Companies with more than 500 employees will have until June 2008, companies with fewer than 500 but more than 20 employees will have until June 2009 while companies with fewer than 20 employees will have until June 2010 to comply with the new rules.
Under the final rule, dietary supplement manufacturers will have to evaluate the identity, purity, strength and composition of their products.
Products that contain contaminants, or do not contain the ingredient they claim to have, will be classed as adulterated or misbranded by the FDA.
The rule is phrased in such a way that it can evolve with scientific improvements in ways of identifying ingredients and their composition and measuring their purity strength.
The purpose is to protect consumers from products contaminated with toxins, bacteria, pesticides, glass, lead and other heavy metals and to prevent misleading labelling, improper packaging, inclusion of the wrong ingredients, or incorrect amounts of ingredients. The FDA says products have been recalled in the past for these reasons.
A companion document to the final rule outlines a process by which manufacturers can petition for exemption to the need to comply with the 100 per cent identity test. Such exemption may be granted if the dietary supplement manufacturer can provide enough evidence that the reduced testing would still ensure the identity of the ingredient.
The FDA is asking for the public to comment on the interim final rule. This phase lasts 90 days and finishes on the 24th September. Any comments should be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.
The FDA does not have powers to regulate the advertising of dietary supplements, only the manufacture, storage, packaging and labelling. Policing the advertising is the realm of the Federal Trade Commission (FTC).
The FTC has an online guide called Dietary Supplements: An Advertising Guide for Industry, with illustrations of what can and cannot be claimed in advertisements about dietary supplements. For example, if an advertisment says that 90 per of cardiologist take the product, then the advertiser must have evidence to substantiate the direct claim (that indeed 90 per cent of cardiologists take it) and the implication that the product is good for the heart.
Written by: Catharine Paddock
Writer: Medical News Today