In the world of "current Good Manufacturing Practices" (cGMPs or GMPs), producing a correct finished product is not nearly good enough. You also have to follow proper procedures for how to handle the ingredients, make the product, package it, store it and move it.
Finally implementing a power it was given back in '94, the U.S. Food and Drug Administration has now proposed new regulations that would establish cGMPs for dietary supplements. Many dietary supplement companies have been operating for years using industry-developed GMPs, since they recognized long ago that controls were needed both to achieve their own quality goals and to win the public's confidence.
The proposed dietary supplement regulations cover personnel; physical plants; equipment and utensils; production and process controls; holding and distributing; consumer complaints related to GMPs and, records and record-keeping. A key element of the proposals calls for testing of finished products before release provided scientifically valid analytical methods exist, and if they don't, component testing and in-process testing are needed.
Businesses that perform some but not all steps in manufacturing or distribution would have to comply with those portions that apply to them - for example, if you only warehouse supplements, you need to comply with the holding and distributing, and record-keeping GMPs. Both supplement products and dietary ingredients would be covered, as would be imports.
Under the philosophy of GMPs, what matters most to FDA is that you have control over your process, that you can make the product the same way the first time and every time, and prove that you can with documentation.
GMP regulations for drugs have been in place for decades, explaining how to translate this principle into action, and FDA announced in August '02 that it was overhauling those regulations. GMPs for foods are also in FDA's regulations, though they are less extensive.
The importance of GMPs is built right into the Federal Food, Drug and Cosmetic Act. For example, one definition of "adulterated drugs" is a drug for which "the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess." 21 U.S.C. $351(a). The law also says that dietary supplements that are prepared, packed or held under conditions not in compliance with cGMPs are adulterated, and gives FDA the power to make cGMP regulations for such products. It also instructs FDA to model them after food cGMPs, and not to make "standards for which there is no current and generally available analytical methodology."
So yes, even if you can demonstrate that the finished product is perfect in every way, the Act makes it a violation if proper practices were not followed in making it.
As has been noted here previously, the law does not require dietary supplements to obtain pre-marketing approval. But that's how it is for other types of foods, and dietary supplements are defined by the Act as a type of food.
Still, they are hardly unregulated. Dietary supplement manufacturers are responsible for assuring that the products are not unsafe, adulterated or misbranded, and must have substantiation for any labeling and advertising claims, such as claims of effect on the structure or function of the body. Moreover, regulations dictate that ingredient and nutrition information must appear on the labeling, and specify how it is to appear. FDA has explicit power to remove unsafe dietary supplements from the market.
In its proposals, FDA cited the more than 7,000 adverse event reports it has received since '93, and said some supplements have been found to lack the stated content of active ingredient, others to be contaminated with microbes, pesticides or heavy metals. FDA says the GMPs will attack these problems and also will control against product with too much active ingredient; those with wrong ingredients; variations in product sizes or colors; improper packaging; and labeling errors.
FDA says its primary purpose for the rules is to "protect consumers from adulterated and misbranded dietary supplements due to improper manufacturing, packaging or holding practices." The rules are intended to describe minimum GMPs for those who manufacture, package or hold dietary ingredients or supplements, so that they can create a controlled environment that will help them produce quality products with greater consistency, and will give consumers "greater confidence that dietary supplements contain the dietary ingredients that they are supposed to contain and that these dietary ingredients were evaluated for their identity, purity, quality, strength, or composition."
To do that, FDA has proposed that manufacturers establish specifications for the products they make, so that the GMPs would then be focused on assuring that those specifications are achieved first time, every time. A reader-friendly Q & A format, with the titles of each regulation phrased in question format, reflects some manner of a 21" century anti-bureaucratic nod.
The proposals address packaging explicitly in several spots. Most notable - Proposed section 111.35 on production and process controls says the packaging that might contact the dietary supplement or ingredient must be "safe and suitable for its intended use and comply with all other applicable statutory and regulatory requirements under the [Federal Food, Drug and Cosmetic] Act and must not be reactive or absorptive so as to affect the safety of the [product]."
- Proposed section 111.40 says packaging and labels must be visually examined, and must be quarantined prior to quality control testing, examination and sign-off. Track and trace techniques must be employed for each lot of packaging and labels.
- Proposed section 111.45 on master manufacturing records makes clear they should include "a description of the packaging and a copy of the label to be used."
- Packaging and labeling operations says proposed section 111.70 must incorporate "necessary actions to ensure that each packaging container for holding dietary ingredients or dietary supplements meets specifications so that the condition of the packaging container will not contaminate your dietary ingredients or dietary supplements nor cause them to deteriorate."
(Source: Packaging Digest)