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.

Essential Legal Checklist for Natural Product & Functional Food Companies

 

Are you wondering how to legally protect your natural product or food and beverage company?  The legal system can seem overwhelming when creating a new product or launching a brand.  Legal obligations and fees vary depending on business structure and location.  Consult a business attorney and a regulatory compliance expert prior to forming your operations structure to determine which requirements apply.  Use our natural product legal decision checklist to make informed choices and find resources.

1. Choose a business structure

This decision needs to be made first.  Your business structure impacts your business registration, tax obligations and personal asset liability.  So choose carefully.  Future structure changes may be limited by your location and cause tax penalties and other negative consequences.

Also choose a structure that offers the benefits and legal protections that are right for your business.  There are nine business structure choices with various considerations .  The most popular for new businesses are:  sole proprietorship, partnership and Limited Liability Corporation (LLC).

• Sole Proprietorship

Set up the most simple business structure if you’re a company of one (for now).  One person assumes liability for company profits and debts.

• Partnership

Choose this for businesses owned by two or more people.  This structure allows partners to share profits, losses and decisions.

• LLC

Consider this for small businesses seeking legal protection but simple formality.  The LLC structure shields owners from personal liability.

2. Register your company name

You put a lot of time and effort into choosing the perfect name for your business.  Protect it by registering it with the right agencies.  Each name registration is legally independent.

• Entity name

This is how a state recognizes your business.  It also protects your name at the state level.  Name requirements vary, but may include distinguishability (name must be different from other similar names).  For example, if the business name “Healthy Vitamins” is registered you may not choose “The Healthy Vitamins”.   Another common name protection is purpose-related.  For instance if your business is registered as “Henry’s Healthy Hub” then “Henry’s Healthy Properties” would likely be denied registration.  Consult your state’s government website for business name requirements.

• Trademark

Trademarks protect your business name at a federal level.  Visit the U.S. Patent and Trademark Office’s website for trademark searches and registration.  Trademark applications must meet legal requirements prior to registration.  To make this easy, consult an experienced trademark attorney.  Or apply yourself.  For help visit the U.S. Patent and Trademark Office’s step-by-step trademark filing tutorial.

• Domain name

This protects your business website address.  A domain name is the name used for your website, like “www.vitawater.com” or “www.gingergells.com”.  Domain registrars, like GoDaddy or Domain.com, register domains through the Internet Corporation for Assigned Names and Numbers (ICANN).

• Doing Business As (DBA)

Use this when the operating name of your company differs from the legal name.  For instance, if you’re “Joan Doe” conducting business as “Natural Vegan Products” you may need a DBA.  Some states require filing of this name to protect consumers.  So consult your state’s government website for DBA requirements.

3. Obtain an Employer Identification Number (EIN)

Businesses located in the USA or a U.S. territory need to apply for an EIN.  The IRS uses this free service to identify your business for tax purposes.  Don’t fall for scammers charging for this service.

You can easily apply online.  This requires a valid Taxpayer ID (SSN, ITIN, EIN) and the ability complete the application in one session.  You can’t save the application and return to it later so keep this in mind.  Also inactive sessions expire after 15 minutes.  Apply online now.  The system validates the information upon submission and an EIN is issued immediately.

You can also apply by fax, telephone and mail.

4.  Obtain business permits and licenses

Avoid one of the most common mistakes made by new business owners:  failing to obtain necessary permits and licenses. Make sure your business stays open by obtaining the required legal items.

• Business license

Contact your city to obtain a business license.  This grants you the right to do business in your city.  Other permits business permits vary.  Check if you need fire department, air and water pollution control, sign usage, and county permits.  Visit your local government website for more information.

• Sales tax license  

Companies selling taxable goods and services must obtain a sales tax license.  Requirements vary by state so check with yours.

• State licenses, certifications, and occupational permits 

Most states require people working in select professions to meet legal requirements.  So contact your state government office for a list of these professions.

• Federal business license

Some companies, like those selling meat products and fruits and vegetables, require this license.  Consult the SBA’s licenses and permits site for more information.

• Health department permit and FDA registration

Companies holding, distributing, manufacturing and warehousing food to customers or wholesalers need both of these  The Health Department will inspect your facility prior to issuing the permit.  The FDA requires that you register so that in the event of a serious adverse reaction to your product(s), a product recall, etc. your contact information in the system allows for a swift response to protect public health and safety.

5.  Draft legal documents for hiring contract workers

Do you plan to hire contract workers:  individuals providing goods or services to a company who aren’t a company employee?  For consultants, artists, web designers or other contract workers, make sure to obtain legal documents before work begins.  Contractors may be difficult to track down later.

• Nondisclosure / Confidentiality Agreement (NDA)

Protect sensitive company information by requiring contract workers to sign an NDA.  Click here for a sample Natural Product NDA / Confidentiality Agreement you can modify.  Have an attorney review your NDA to ensure validity.

• Proof of qualifications

Keep a copy of the contract worker’s application, resume, and other proof that they quality for your job.  Also make sure contractors realize they are filling out a contract worker application and not an employee application.

Verify their Tax ID and contact references to make sure the worker’s qualifications are valid.  Also, conduct a background check if the contractor is working with sensitive information or providing in-person services to customers.

• W-9 Form  

Independent contractors paid $600 or more per year need this form.  You will need the contractor’s taxpayer identification number, name and address.  The W-9 excuses your company from having to withhold payroll taxes for contract workers.  It also provides the information needed to create a 1099-MISC Form for contractors for the tax year.  The 1099 is the contractor equivalent of the W-2 form that you use for company employees.

• Written contract

Prepare a contract for each contract worker.  This protects your business if a dispute arises.  Make sure a contract includes the scope of the work, who owns the work, payment information, and an independent contractor statement.  Have both parties sign the contract.

Even though it might seem tedious, take the time to meet your legal requirements.  Remember business laws and regulations vary by industry and state.  Understand which requirements apply to your business, and consult an attorney for necessary guidance when needed.  If your company doesn’t have a legal team, don’t skip legal steps.  Type “free legal help” into your browser to find free or inexpensive help.  My browser returned over 2 billion hits on this search term.  Sleep easy at night knowing you and your company are legally protected.

 

Kendeyl Johansen, a tech geek and award-winning journalist, creates multimedia health and wellbeing content.

Susan Ulery utilizes her legal background plus 20 years of manufacturing expertise in the dietary supplement industry to help clients overcome regulatory challenges.