FDA Regulation of Dietary Supplements

FDA Regulates Dietary Supplements

How does the FDA regulate dietary supplements?

The Food and Drug Administration (FDA) has regulated dietary supplements since at least 1938. At the time they were regulated like any other food, however. In the 1980’s they became defined as “food additives,” leading to a lot of confusion and inconsistent regulatory standards. The Dietary Supplement Health and Education Act (DSHEA) of 1994 set the foundation for the way dietary supplements are categorized, sold and regulated today.

While there are some critics of the FDA’s regulation of dietary supplements, they do their best to keep the public safe. Important updates were implemented in the 2011 Food Safety Modernization Act (FSMA). The scope and form of regulation can be divided into three areas: formulation, manufacturing processes, and consumer safety. Each area works in concert to create products that are researched, reliably potent, and safe.

Formulation of Dietary Supplements

The definition of a dietary supplement, as established in DSHEA, encompasses “vitamins, minerals, herbals and other botanicals, as well as amino acids and other dietary substances used to supplement the diet, and any concentrate, metabolite, constituent or extract of those items.” It is the manufacturer’s responsibility to be able to conduct testing for every ingredient they use. That testing is used to prove that their product is exactly what they say it is and is as potent as they claim. Those tests may be for final product or as an ingredient sold to another manufacturer.

In instances of business to business sales, it is also the obligation of the buyer to validate the claims of the seller. When an audit or product incident occurs, the FDA will validate not only the results of the tests but that the tests are appropriate and accurate.

If a product is being sold to a consumer the manufacturer must be able to prove that every batch of the product meets the claims made on the product label. Whatever company has their name on the label is responsible for the claims made on the label; whether it is the manufacturer or an Own Label Distributor (OLD). This is done by keeping records of their ingredient lab results and what batches those ingredients went into.

Manufacturing Process

The FDA further regulates dietary supplements by monitoring a company’s manufacturing process though prescribed Good Manufacturing Practices (GMP’s). Current GMP’s (cGMP) say that any product “has been prepared, packed or held under conditions that do not meet current good manufacturing practice regulations” to be compromised and thereby unfit for sale. The FDA can respond with warning letters and possible prosecution. Consumers are increasingly aware of what they are putting in their bodies.

Third party certification programs like the Safe Quality Food (SQF) Institute are becoming a standard bearer recognizable by consumers. Their certifications typically go above and beyond what is required by the FDA but also gives companies a competitive advantage. Buyers and retailers may also require certain certifications to be shelved in their stores.

Consumer Safety

Since the enactment of DSHEA in 1994 the FDA has been able to request voluntary recalls from manufacturers if it determined that there was “a serious or unreasonable risk of injury or illness.” The Nonprescription Drug and Dietary Supplement Consumer Protection Act of 2006 requires manufacturers to alert the FDA of serious adverse events that are reported. Manufacturers are also required to maintain a record for six years of any and all complaints and events reported to the company.

The Food Safety Modernization Act (FSMA) put the sharpest arrow in the quiver of the FDA in terms of authority. On top of their audits of GMP’s the FDA may issue a mandatory recall if it determines that a product may cause serious adverse health effects.

Today’s FDA has a powerful arsenal to ensure the products dietary supplement manufacturers produce are safe and effective. Between them and the third party certificates available consumers can be assured that the products they purchase will be as advertised and safe to consume.

6 Manufacturing and Food Safety Software Must-Haves

6 Manufacturing and Food Safety Software Must-Haves

Now more than ever food and beverage manufacturers are up against greater challenges. Antiquated pen-and-paper tracking is still surprisingly prevalent in even large and mid-size companies. These systems can open the door to issues when it comes to quality and food safety requirements. 

Alternatively, the right food safety software can help balance business profitability and FDA regulatory compliance guidelines. These are six key points to consider when looking at food and beverage manufacturing software.

1. Traceability Software for Food Manufacturing

The most essential assurance that your final product is safe and salable is being able to accurately track qualified ingredients and products through every stage of the manufacturing process. Being able to track individual lots, bins, and ingredients ensures that your manufacturing and quality teams can be proactive in identifying and addressing issues at any point in the production cycle. 

That said, sometimes problems arise. Good traceability software for food manufacturing will tremendously speed up the process in the event of a recall or inspection. The integration of traceability software and your FDA regulatory compliance and food safety software will provide a record of where your components came from and what products they went into.

2. Quality Management

Quality is arguably the biggest part of the manufacturing process. After all, this is the product you’re selling. You can increase profitability and minimize the risk of recalls with an integrated quality management or ERP system as part of your business flow. With an integrated quality system you can hold an upper hand against the competition, rather than being reactive. 

Food safety and FDA regulatory compliance software isn’t just about following the rules. The right ERP platform will ensure your production meets your defined standards — consequently increasing profitability!

3. Inventory Maintenance and Planning

Especially when dealing with perishable goods, managing your inventory is key to maximizing production capacity. Your food and beverage manufacturing software should be able to help you manage “use by” dates and orchestrate your materials management planning and procurement. 

Detailed work-in-process coordination and ingredient requirement anticipation are essential to maximizing your production cycles, labor demands, and ultimate profitability.

4. Food Safety Plans and CAPA’s

Whatever product you’re manufacturing is going to have some unique production process. Your food safety software should help you manage the Hazard Analysis and Critical Control Points (HACCP), process controls, and analysis of the goods you are producing. 

In the event of an audit or recall, you may have to create Corrective and Preventive Action (CAPA) plans. Managing quality and safety manually can leave you with the grueling process of trudging through binder after binder for relevant information. 

Conversely, an integrated food safety software system with FDA regulatory compliance in mind makes your quality management team precise and efficient in the generation of CAPA’s and food safety plans.

5. Batch Recipes and Ingredient Details  

A food and beverage manufacturing software package should be able to track all relevant information about the ingredients in your final product. Your system needs to track things like technical properties, lab results, costing information, allergens, product claims, and history. 

Furthermore, documentation at every step ensures your product is exactly what you claim it is on the label.

6. The Right Solution at the Right Time

The decision to move forward with a software solution is not a decision to be taken lightly. Finding the one that suits your business size and the industry niche is critical. You’re trying to make your manufacturing process smoother and grow your business. 

Full-scale Enterprise Resource Planning (ERP) software can be a costly and complex solution. Fortunately, there are plenty of excellent and capable software solutions.  

Crystal System’s Clarity Plugins provide an advanced ERP System for Natural Products that extends the capabilities of popular software like QuickBooks to help you streamline your manufacturing process without having to invest in a costly and complex ERP System.

Contact us today so we can find the best solution for your organization.

HACCP In Your Manufacturing Process

HACCP In your Manufacturing Process

With the increasingly global nature of the food and supplement industries, quality assurance regulations have become incredibly complex. Despite this evolution, a surprising number of companies still rely on a paper-based system for their Hazard Analysis and Critical Control Points (HACCP) plan. HACCP is an internationally recognized system of proactivity in the management of a company’s quality and safety obligations.

The FDA requires manufacturers to have a HACCP plan in place.

How Does HACCP Fit In and Why Is It Important?

There are a growing number of businesses in the food and supplement industries adopting more modern solutions to a HACCP plan. Finding a business size-appropriate software solution is the direction these forward-thinking companies are going.

A software solution, typically a full-scale Enterprise Resource Planning (ERP) system, can streamline food and supplement manufacturers’ response to issues when they arise. A good ERP solution can help maximize the manufacturing processes too.

The Centers for Disease Control and Prevention (CDC) suggests that the rates of food-borne illness have remained about the same annually in the past decade. That said, recalls have been on a rise, especially since the Food Safety Modernization Act (FSMA). The Food and Drug Administration (FDA) has more authority to monitor and regulate food and supplement manufacturers in an effort to keep the public safe.

The Public Interest Research Group (PIRG) says overall, food recalls have increased 10% from 2013 to 2018. However, these numbers shouldn’t frighten food and supplement manufacturers. PIRG goes on to say that this is likely a result of more advanced identification and detection techniques. The numbers are also likely higher due to companies executing more voluntary recalls. Recalls are more easily executed, or ideally avoided, with the use of well implemented HACCP plans.

Compliance doesn’t have to be hard

An ERP system, big or small, which incorporates quality management, gives a business a leg up on the competition. Companies looking to enlist the help of more advanced software can catch problems as they arise — such as preventing the event of a costly recall.

More importantly, ERP systems aid in the creation of a higher quality product. A solid ERP system helps with developing plans for HACCP. When an issue arises, the system aids in the development of corrective and preventative actions (CAPA)’s too.

A powerful ERP for food and supplement manufacturers doesn’t have to be complex or costly. Crystal System’s Clarity Plugins provide an advanced ERP system using QuickBooks.  Contact us today to learn more or to schedule a demo.