Background info to help you comply with Current Good Manufacturing Practices
The new GMP dietary supplement labeling laws are finally in effect. As of June 2010, dietary supplement manufacturers and distributors in the USA are required to manufacture, label, document, and store products in compliance with the FDA’s cGMP practices (Current Good Manufacturing practices) – cGMP or GMP for short.
For many dietary supplement manufacturers, the new regulations will mean a more complex, traceable manufacturing process. This affects a lot of companies because dietary supplements are a big business. According to the Nutrition Business Journal, dietary supplements are a $23.7 billion industry in the United States.
New labeling laws like these can be very confusing, so I am going to do my best to simplify them so we can all have a better understanding.
Here we go.
What are GMP Practices for Dietary Supplements?
First of all, let me define “dietary supplement” as the FDA defines it: a dietary supplement is any product that contains dietary ingredients such as vitamins, minerals, herbs, botanicals, amino acids or other ingredients used to supplement the diet.
Essentially, GMP makes supplement manufacturers responsible for adhering to a specific set of manufacturing processes, safety procedures, and packaging standards to ensure that dietary supplement labels are truthful and that actual dietary supplement contents match the contents on the Supplement Facts label and are not misleading – in any way.
The GMP regulations are set in place to guarantee to consumers that strength and potency claims and ingredients statements on Supplement Facts label panels are accurate. GMP also makes dietary supplement manufacturers responsible for reporting product quality problems.
GMP is meant to reassure consumers that dietary supplements will not have unsafely high ingredients concentrations, will not have harmful contamination from substances such as toxins, bacteria, pesticides, glass, lead, or other heavy materials, and will not have inaccurate ingredients statements on the Supplement Facts label or misleading claims about ingredients and health benefits.
When the FDA issued its final rule about GMP for dietary supplements in June of 2007, Commissioner of Food and Drugs Andrew C. von Eschenbach, stated,“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.”
Vic Shull, owner of Vitalabs, Inc. agreed that responsible dietary supplement manufacturers also benefit from the new GMP requirements, saying “most legitimate companies have benefited by the fact that less than legitimate companies must now comply.”
What are the Dietary Supplement Labeling Obligations Under GMP Regulations?
The FDA specifies a set of dietary supplement labeling operations under GMP regulations, they go as follows:
- Filling, assembling, packaging, and other operations shall be performed in such a way that dietary products are protected against adulteration.
- Written procedures should be established and followed describing in sufficient detail the control procedures employed for the receipt, storage, handling, sampling, examination, and/or testing that may be necessary to assure the identity of labeling and the appropriate identity, cleanliness and quality characteristics of packaging materials for dietary products and for the clearance of lines between different products.
- For dietary supplements, labels for each different product type, strength, or quantity of contents must be stored separately with suitable identification. (of course, this step is not necessary if dietary supplement labels are printed on demand from a digital label printer)
- Obsolete or non-compliant labels, labeling, and other packaging materials for dietary products shall be destroyed. (again, you would not have obsolete labels or non-compliant if you print your own labels with a digital label printer)
- Written procedures shall be established and followed to assure that correct labels, labeling, and packaging materials are issued and used for dietary products.
- Dietary ingredient and dietary supplement packages shall be identified with a lot number that permits determination of the history of the manufacture and control of the batch.
- Packaged and labeled dietary supplements shall be examined to provide assurance that containers and packages in the lot have correct label, ‘Best Before’, ‘Use By’, or expiry dating, and lot number. The quality control unit shall reject products not meeting specifications.
What Will the FDA Do to Administer GMP for Dietary Supplements?
The FDA will now inspect dietary supplement manufacturing facilities and carefully monitor dietary supplement labeling to make certain that the products are produced safely, contain no contaminants, and are labeled accurately. GMP practices require the highest quality throughout the manufacturing, labeling, packaging and storing processes.
The Food & Drug Administration has long maintained GMP regulations as a means of ensuring quality for pharmaceuticals and medical devices. Now, with the new GMP regulations for dietary supplements, vitamins, minerals, herbals, and other nutritional products in the United States are now being manufactured and labeled in much the same way as foods and pharmaceuticals.
Of course, there is still a major difference between marketing dietary supplements and pharmaceuticals: manufacturers do not need pre-approval from the FDA to begin selling dietary supplements, but it takes several years of clinical trials before the FDA approves pharmaceuticals for sale.
Who is Subject to Maintaining Compliance with GMP for Dietary Supplements?
GMP requirements apply to each and every domestic and foreign company that manufactures and packages dietary supplements for sale in the United States, including all those involved in manufacturing, distributing, testing, quality control, and labeling dietary supplements.
Can I Print Dietary Supplement Labels On-Demand?
Yes. GMP labeling requirements require manufacturers to store labels separately for each product, and to discard obsolete dietary supplement labels, but these concerns can be avoided if you print your own dietary supplement labels for each batch, instantly. When you use your own in-house label printer to make labels for dietary supplements, you can ensure that labels are printed for each batch of supplements.QuickLabel color label printers can print serialized labels in full-color, photo-quality. That allows you to print dietary supplement labels with logos and graphics while also printing ingredients panels, batch codes, lot codes, color codes, and expiration dates at the same time, on the same label. If you need primary display labels for bottles and jars, you can print your own labels in color. You can also print color labels for cases and cartons, or make barcode labels with a Pronto! monochrome label printer.
What Are the Required Elements of a Dietary Supplement Label?
Dietary supplement labels must include: a Supplement Facts panel for all active ingredients, an “Other Ingredients” panel that lists every inactive ingredient contained in the supplement product; a statement identifying the product as a dietary supplement; and supplement labels must state the name and address of the manufacturer or distributor. If the product is an herbal, the label must also state the plant from which the supplement is derived.
It’s fine to make “claims of nutritional support” on your supplement label, as long as you have the data to justify your claims. However, supplement labels with claims regarding functional health benefits such as “calcium builds strong bones” must include a disclaimer statement on the label which states that the FDA has not evaluated the claim and that the product “is not intended to “diagnose, treat, cure or prevent any disease.” Despite this disclaimer, all health claims must be truthful and not misleading to consumers – or the FDA will recall the product and may fine the manufacturer.
Important note: It is illegal to make a dietary supplement label claim that indicates that that the supplement is a treatment or cure for any condition or disease.
Supplement labels are regulated by the FDA under the DSHEA (Dietary Supplement Health and Education Act of 1994).
Can Manufacturers Be Exempted from GMP for Dietary Supplements?
The Interim Final Rule (IFR) makes available a petition for manufacturers who want to apply for exemption from the 100 percent identity testing for dietary supplement ingredients. When the manufacturer petitions the FDA, they must provide data that shows that less than 100% identity testing will not diminish assurance of correct dietary ingredient. Although a manufacturer can be exempted, they are still responsible for producing dietary supplements that meet GMP standards for purity and labeling.