Current Good Manufacturing Practices (cGMPs)

To sell botanical products at retail, one will likely need to comply with the relevant federal food safety regulations for foods, dietary supplements, or cosmetics (whatever the case may be). Foods will fall under the Produce Safety Rule or the Preventive Controls Rule with their Current Good Manufacturing Practices (cGMPs) for Human Food. If you are producing dietary supplements, there is a separate set of Current Good Manufacturing Practices to follow. And, just recently, a new Current Good Manufacturing Practices rule was enacted for cosmetics.

Note that this section only covers federal safety and production regulations. States will often have additional requirements for selling farm products, including licensure or cottage food laws that dictate what can and cannot be processed in a home kitchen. So, the information in this guide should be seen as the first layer in a compliance plan. The federal regulations set the minimum requirements. If states have additional regulations, they will complement the federal rules but could require more effort on the part of the producer.

All the federal regulations are designed to ensure consistency, cleanliness, and the ability to trace a product back to its source if needed. Sounds simple enough, right? Unfortunately, compliance with these regulations is not simple.

As a preview, all of the cGMPs will require health and safety basics, such as having sanitary equipment and a healthy staff that follows sanitation guidelines and won’t work when sick with a communicable disease. The sanitation rules might take some thinking, planning, and changes to your lab or the equipment you use. For example, wood is not considered sanitizable and should not be used in a production facility, whereas stainless steel and most plastic surfaces are considered sanitizable. Other rules govern how batches of products are organized and tracked throughout your facility and after you’ve sold them. When we zoom out and talk about the basic goals and outlines of the rules, they seem sensible and easy to manage. However, even just the sheer number of rules can be overwhelming. Perhaps the most burdensome part of the cGMP compliance process will be the time and effort needed to understand the rules, the reasoning behind the rules, and developing systems for the extensive recordkeeping requirements.

While it may feel daunting to learn complex regulations, do keep in mind that there are small farms and botanical businesses that are able to create processing facilities that comply with the regulations. It is possible. However, the process will take an initial investment of time and money. Producers will want to find and take the appropriate cGMP courses (see resources at the end of this section). Often, a consultant, peer, mentor, or herbal association that can share a safety plan, recordkeeping templates, and advice will be essential. 

Food Safety Regulations: Produce Safety Rule and Preventative Controls Rule

You might already know the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) that governs field production and post-harvest packing. And, if you make any value-added food products, you might also already know that additional food safety rules under the Preventive Controls Rule (PCR) can be triggered with food processing, whether it is on-farm or off-farm.

There are a few very minimal processing activities that can take place on a farm without violating the Produce Safety Rule’s definition of a farm. In relation to botanical production, farms that grow their own botanicals can dehydrate, then package and label their farm products on-farm without triggering the cGMPs of the Preventive Controls Rule. This minimal processing is controlled by the food safety rules found in the Produce Safety Rule. PSR food safety rules are less onerous and cover the growing, packing, and dehydrating of those products. However, any processing on top of the dehydration, which would include chopping or mixing the ingredient with another farm product, would mean the PSR no longer controls, and the more challenging Preventive Controls Rule would come into play.

These distinctions are relevant for botanical producers who want to dry the botanicals they grow and to sell as a dried tea. Without a structure/function claim on the label, most teas can be sold as food products. Each producer will need to determine what level of processing they want to engage in, but dried teas have maybe the most flexibility as to what safety regulations will apply.

This guide is not a guide for food processing, so we will not be going into detail on food safety requirements other than this overview that puts the various regulations into context. It is also worth knowing that the Preventive Controls Rule for food processing does have exemptions for certain retail food establishments, which include many producers who sell direct-to-consumer. There are also exemptions for certain low-risk manufacturing and processing conducted by small businesses on farms for specific low-risk foods. Furthermore, very small businesses can be considered ‘qualified facilities’ and have modified (lesser) requirements under the PCR. It is important for botanical producers to consider how these rules and exemptions apply to their operations. Depending on a business’ products and goals, it can be possible and advantageous to stay within the scope of the food safety regulations rather than enter into the realm of dietary supplement regulation, including dietary supplement cGMPs. A producer that makes products that could be considered conventional foods might decide that it is beneficial to make marketing choices (i.e., decide not to make any structure/function claims) that keep their products in the conventional food regulatory category. 

Dietary Supplement Current Good Manufacturing Practices

Unlike food production cGMPs, there are few exceptions to the dietary supplement cGMPs. There is, for example, no exception for a small business. However, there is an exemption if you are only selling wholesale. And, if you are an herbalist who advises individual clients and makes specific products for that individual, you are less likely to see FDA enforcement based on cGMPs. Even then, though, it isn’t impossible.

Dietary supplement facilities must be registered with the FDA. Establishing a Dietary Supplement cGMP program requires appointing at least one quality control manager and developing extensive plans and recordkeeping procedures. The cGMPs must become a routine aspect of your operation, as all inspectors live by the motto, “If it isn’t written down, it didn’t happen!” To establish a cGMP program, the quality supervisor is required to get training. Look for training programs that supply templates for procedures and recordkeeping. If you can find such a program, you will save yourself a lot of headaches! This guide will not cover cGMPs extensively, but see the table below for an abridged overview of the major requirements in sections of the cGMP rules for dietary supplements.

TABLE 6. Selected Overview if cGMPs for dietary supplements 

Personnel, Physical Building and Grounds, Equipment

Selected Rules:

  • All employees must be well, clean, and practice appropriate hygiene while preparing products
  • Lab must be kept clean and in good repair, water must be potable, cleaners and sanitizers must be approved for their intended use
  • The flow through the lab must support cleanliness (avoid cross-contamination)
  • Equipment must be sanitizeable and not create crevices where things can collect
  • Equipment must be calibrated, maintained and inspected routinely

Selected Recordkeeping Requirements:

  • Cleaning, sanitizing and maintenance procedures must be in writing and logged
  • All staff must be trained in health and safety and water testing must be on file
  • Equipment that must be calibrated must have records of these steps

Manufacturing Process

Selected Rules:

  • Develop specification for quality product, and verify that all product meets those standards
  • Must keep records to show that the product comes from your fields or have proof of the identity of product you buy in

Selected Recordkeeping Requirements:

  • Create a Master Manufacturing Record (MMR) that holds the specifications for your products
  • Create a batch production record for each batch created, and that it complies with the MMR

Distribution

Selected Rules:

  • Must have some way to trace your sales, not necessarily a lot number
  • Must pack and hold the product in conditions that keep that product safe (does it need refrigeration?)
  • Hold reserve samples of each batch for two years from date of distribution
  • Must have a process for receiving returned product, quarantining if needed and responding to customer complaints

Selected Recordkeeping Requirements:

  • Sales records–a process for tracking where certain batches were distribute

Are There Alternatives to Complying with Dietary Supplement cGMPs?

Botanical producers who want to produce and market dietary supplements to the public will have to find a way to comply with the required cGMPs. For those that cannot or do not want to comply with the cGMPs (at all or on their own), exercise caution and consider exploring the limited options you have for selling botanical products without violating the rules for dietary supplements. Some options to explore includes:

  • Sell your unprocessed botanicals wholesale,
  • Only make botanical products for individual clients or family members (but don’t practice medicine without a license),
  • Reevaluate your product line and marketing strategies so you are only producing botanical products that can be marketed as food or cosmetics,
  • Outsource processing of your farm-grown botanicals to a cGMP facility that provides that service, or
  • Look for cGMP facilities in your area that allow entrepreneurs to rent space to process in their facility. 

A Farmer’s Perspective: Navigating Safety Regulations

When Kara began her botanical business, she encountered a lot of local and state regulations regarding farms that didn’t clearly apply to her botanical operation. Because of this, she saw two options. She could interpret herself as being exempt and fly under the radar from the rules with the risk of being less marketable, or she could try to get into compliance as much as possible to increase her resilience. Part of this decision-making was acknowledging that she works in an herbal community where people aren’t paperwork-oriented, so going the paperwork route felt like leaving her community behind. For her, keeping up with regulations is a struggle of balancing business principles with personal principles while trying to navigate risk and administer care to others. 

Resources for Dietary Supplement cGMP Knowledge

Below is a short list of some resources we’ve come across that teach about dietary supplement cGMPs. Some are more geared toward herbalists or small producers. Others, like the NSF course, will be made for all producers–large and small. Start with the smaller, shorter, and cheaper ones and build up if you decide this is a path for you!

Cosmetic Current Good Manufacturing Practices

The cosmetics industry was recently hit with a huge change to its safety and processing regulations. The Modernization of Cosmetics Regulation Act (MoCRA) gave the FDA new authority to govern cosmetics. Certain Cosmetic facilities are now required to register their facilities, list their products and the product ingredients with the FDA, substantiate the safety of their products, follow cGMPs, and report adverse events based on use of their products.

However, there is good news! This law does have exemptions for small businesses! Certain small businesses are exempt from the cGMP, registration, and product listing requirements. Businesses with domestic cosmetic sales under $1 million over the past three years are exempt. This exemption will cover most farm based botanical businesses. To learn more about this new law, see this post by the FDA.