What are GMPs?

Under FDA regulations, all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with testing, quality control, and distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control.

Good Manufacturing Practices (GMPs) are a defined set of production and testing processes intended to ensure a safe and quality product including the absence of undeclared ingredients or unacceptable levels of contaminants.  These standards of operation cover personnel, physical plant and grounds, equipment and utensils and production, and process requirements for everything from quality control of ingredients to packaging and labeling.  Third-party organizations are designated as approved GMP certifiers by working with all government, consumer, and industry stakeholders and producing an agreed-upon set of standards, conducting manufacturer education and inspection services, and providing documentation and approval for the display of the GMP seal upon a product. 

The Natural Products Association, a professional trade organization for the natural food industry, was the first organization to offer a third-party GMP certification program for the manufacturing of dietary supplements and dietary ingredients. NPA established its GMP standards for dietary supplements in 1999 and updated the standard in 2000.  They also offer certification of products in the Home Care and Personal Care categories.  

The other third party GMP certifiers for the natural product industry are NSF International and United States Pharmacopeia (USP).

 

Why this matters:

cGMPs reflect the current, up-to-date, best practices for manufacturing.  The standards set by 3rd party certifying organizations assure consumers that product quality is maintained throughout production and reflects any updates or improvements that may be made in quality assurance practices, standards and measures. 

Consumers look for GMP certifying seals to know if the manufacturer is performing according to the law and best practices.  Products without the seal may be following best practices, but they are not “certified” so they cannot display a GMP certified seal.

Quality Standards

In general, the quality standards expressed in GMP certification assures the consumer that:

  • Manufacturer supplied information about the product is true and accurate
  • The label reflects the actual ingredients 
  • The product is free from contaminants and impurities and is safe to consume

Customers also look for information to determine:

  1. If the ingredients are considered “natural” and not synthetic.   Many consumers become deeply educated about ingredients.  They look for understandable words for ingredients they might find in their own kitchens, i.e. organic information and the absence of artificial flavors, sweeteners, preservatives, and other additives.   
  2. If dietary supplements work.   The best evidence of the efficacy of nutritional supplements can be found in scientific research and clinical trials on the ingredients.  Reputable, quality manufacturers will reference their research on their websites and in their product literature. 
  3. If the ingredients in the supplements will have an adverse effect or interact with their prescribed medications.   Some ingredients in nutritional supplements will interact with pharmaceutical drugs or other nutritional supplements ingredients in an adverse way.  For example, people taking prescribed blood-thinning medication should avoid taking supplements with Vitamin K since Vitamin K interferes with the medication and increases the risk of blood clots; or people who are taking anti-depressants should avoid consuming L-Tryptophan Peptide for relaxation and sleep.  Warnings should always be stated on the label.
  4. If the product was produced in keeping with sustainable and humane practices.  Many customers prefer products that avoid animal testing, are produced with high animal welfare standards and environmental integrity, from certified organic and non-GMO certified to recyclable or compostable packaging.  Manufacturers provide information on their participation in sustainable practices on their product packages, in their literature, and on their websites.

Sustainable Packaging

Contrary to most perceptions, landfills of trash and rubbish are managed in a controlled, airtight environment to avoid uncontrolled biodegradation that can cause groundwater pollution, methane gas emissions, and unstable subsoil conditions.  The latest available figure from the Environmental Protection Agency (EPA) shows about 251 million tons of trash were generated in 2012.  At the same time about 87 million tons or 34.5% of trash was recycled or composted, an amount over twice the rate of recycling (including composting) in 1990. About 30% of all the waste comes from containers and product packaging.  Reduction of mummified packaging trash and the switch to recycling and composting saved more than 168 million metric tons of carbon dioxide equivalent emissions (more than three times the amount generated by 33 million passenger vehicles) and more than 1.1 quadrillion Btu of energy – the amount consumed by almost 10 million U.S. households a year.  In keeping with its values, the natural product industry takes the need to increase environmental sustainability, reduce negative environmental impact, carbon footprint and decrease waste seriously, and actively participates in packaging practices that are healthier for the planet, animals, and people.    

Minimal packaging – Using less packaging materials and choosing packaging materials that can be reused, recycled, or composted.

Renewable and recyclable materials – Use packaging that is both made from recycled content and can, itself, be recycled.  The most commonly recycled materials are glass, steel, aluminum, cardboard, and paper.   In the 1990s a method to label recyclable plastics was created, inserting a code number into a triangle, with each number associated with a specific type of plastic.  The most commonly recycled plastics today are #1 and #2.  Plastics made from polypropylene are labeled #5 and are commonly used in yogurt, cottage cheese, hummus, and medicine bottles.  No. 5 plastics can be recycled and repurposed into toothbrush handles and other utensils.

Cradle to Cradle certified – The phrase cradle to cradle (c2c) was coined by Walter R. Stahel in the 1970s to describe a system of lifecycle development, and adopted by a team at the Environment Protection Encouragement Agency (EPEA) in the 1990s.  By applying c2c principles, packaging could be made from reusable materials, then recycled back into the production of other goods and products without producing any waste.   In 2002, William McDonough & Michael Braungart, published a landmark book Cradle to Cradle: Remaking the Way We Make Things, and began the movement to certify products and packages that applied these principles.

Biodegradable/Compostable – Composting is the process of controlled biodegradation outside a landfill.   By carefully controlling feedstocks, moisture content, and oxygen levels, composters transform biodegradable materials into useful products that are used in farming, gardening, and soil conservation. 

BPA Free – BPA is Bisphenol A, an industrial chemical that has been used to make certain plastics and resins since the 1960s.  BPA is found in polycarbonate plastics and epoxy resins. Polycarbonate plastics are used in containers that store food and beverages, such as water bottles.   Epoxy resins are used to coat the inside of metal products, such as food cans, bottle tops, and water supply lines.   Some research has shown that BPA can seep into food or beverages from containers that are made with BPA.  Exposure to BPA is a concern because of possible negative health effects of BPA on the brain, behavior, and prostate gland of fetuses, infants, and children.   The FDA is reviewing BPA and has not yet produced a definitive conclusion on its safety; in the meantime, consumers have educated themselves about the potential negative health effects and are avoiding packages made with BPA.  More and more natural product packages are BPA Free and many packages display BPA Free icons or labels.

Healthier packaging qualities – Packaging companies emphasize other green packaging attributes including chlorine and bleach-free, renewable resources for raw materials such as bulrush, bagasse, bamboo, and wheat stalk, no use of trees, and food-grade additives when needed for moisture and grease resistance.

 Why this matters:

The natural product industry has supported healthier, more sustainable agriculture and manufacturing from the beginning.  Over the years, as consumer demand grew, the industry has taken a leadership role in the development of sustainable packaging practices.  As a result, the movement toward recyclable and compostable packaging has grown substantially and is now mainstream, reducing waste, carbon emissions, and environmental degradation.   These values are important to the natural retailing business since consumers will more actively engage with and be loyal to stores that support their own values for a clean and healthy environment.

 

Words to Remember

BPA FREE

Plastic and epoxy containers that do NOT contain bisphenol A, an industrial chemical that is known to cause harmful effects on the brain, behavior, and prostate glands of fetuses, infants, and children.

 

COMPOSTABLE

Describes a product package that can biodegrade outside a landfill without leaching harmful chemicals into the soil or water.

 

GMP

Good Manufacturing Practices as defined by the FDA and third-party certifying parties for the manufacturing of foods and dietary supplements.

 

SUSTAINABLE PACKAGING

Product packages that use less materials, renewable and/or recycled raw materials, is BPA free, and can be composted or recycled.

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