For the millions of people who use backpacks and purses, there’s a good chance a stick pack is lying at the bottom of it. Over the last few years, stick packs have effectively revolutionized the way we pack and prepare beverages. Instead of the hefty container of Kool-Aid sitting in the kitchens of old, people can just grab a stick pack of coffee, tea, or juice and add it to a water bottle – but that’s not all! The stick pack is much more versatile than that. It’s used in survival training, can carry all kinds of baby food and formula, small or daily amounts of medicine, and is even being used to carry skincare or other beauty products.

Stick pack products are taking over, but the regulations and details of manufacturing and selling them are a bit complicated.

Importance of Regulatory Compliance

New innovations and inventions are great, but they typically come under heavy scrutiny from regulatory commissions like the FDA. It only makes sense, if someone is going to package baby food or beverage-based products the containers in which they’re packaged need to be as safe as possible. How does one recognize or navigate those many regulations and requirements though? With some help from experts.

The implications of incorrectly manufacturing stick pack products are huge. It could raise health concerns for millions of people, especially when factoring in international standards and regulations. To truly build the kind of trust that companies want from stick pack manufacturers, credibility needs to be established. That means taking the necessary steps to ensure that stick-pack containers are up to every necessary standard.

What are those standards? Let’s dive in.

FDA Regulations for Stick Pack Products

Role of the FDA

The Food and Drug Administration (FDA) is one of the most important agencies in the entire United States and possibly the world. It regulates everything from medicines to food, including the containers and manufacturing components used to make or contain them. While many have complained about the agency’s power, most people have undoubtedly been helped by its many regulations. That includes those for stick pack products.

Unlike some other agencies, the FDA also has the power to enforce its laws and regulations. The means with which they enforce them should be a major concern for any company creating products that fall under their regulations. Those methods include:

  • Warnings
  • Surveillance Measures
  • Shipment Injunctions
  • Restraining Orders
  • Seizures
  • Monetary Penalties and Fines
  • Criminal Prosecution

Relevant FDA Regulations

The FDA has numerous acts that effectively describe the regulations for different practices, products, manufacturing methods, and much more.

Here are a few examples that are relevant to stick pack manufacturing:

Good Manufacturing Practices (GMP)

  • These ‘practices’ dictate the standards for the manufacturing facilities or factories and the processes used to create a specific product
  • This could include regulations on waste management, machine and facility cleanliness, and assurances that the relevant supervisors and workers are on hand when needed.

Food Safety Modernization Act (FSMA)

  • Approved in 2011 under the Obama administration, the FSMA is targeted at preventing illnesses by ensuring the safety and cleanliness of every step in the food supply process
  • This includes accreditations for laboratories and processing facilities and regulations on water and ingredients traceability to ensure the FSMA protects both human and animal food

Dietary Supplement Health and Education Act (DSHEA)

  • Created in 1994, DSHEA regulates vitamins and dietary supplements
  • It was intended to ensure that vitamins and other “normal” supplements don’t face the same scrutiny and regulations as actual drugs and medications

FDA Food Labeling Requirements

Books shouldn’t be judged by their covers, but many foods and supplements should be. Labeling is an incredibly crucial part of the process. The FDA’s regulations seek to remove any concerns consumers would have over the safety or quality of their goods, and it does so with a useful guide and some basic information requirements.

The Food Labeling Guide

  • The introduction of foil labels that increase the prominence of the company and relevant safety information

Mandatory Label Information

  • Statement of identity
    • A clear description of the food or contents of the container
  • Net Quantity
    • The amount of food or contents
  • Nutrition Facts
    • Basic information about the food’s nutritional value
  • Ingredients
    • List of the ingredients unless there’s some sort of exemption
  • Manufacturer’s Name and Address
    • The names and addresses of the manufacturer, packer, and potentially the distributor

Labeling Requirements Specific to Stick Pack Products

While the nuances of labeling can change from product to product, when it comes to stick pack containers there are a few requirements that can’t be ignored.

Design and Layout Considerations

  • Due to the limited space on stick pack packaging, the nutrition information needs to be prominently displayed in the same format as the labeling guide from the FDA
  • As that complaint letter mentioned, font size and legibility are extremely important. All nutrition facts and ingredients must be displayed and written in a font that is easily legible

Nutritional Information

  • All nutrition facts and information need to be prominently displayed on the back or surface of the stick pack using the label example from the FDA guide
  • Serving sizes need to be described with a comprehensive unit of measure that also references the exact contents in a single stick pack container

Allergen Labeling

  • All major or minor food allergens need to be clearly identified in a prominent way for all consumers to see
  • Those allergens need to be listed in simple text that utilizes one of the “big eight” allergens by listing said allergen next to the relevant ingredient in parenthesis

Claims and Statements

  • All health claims need to be reviewed by the FDA but are allowed on both food and supplement products
  • Nutrient claims need to be defined and displayed, including the relevant amounts using the appropriate units of measure (most often grams)
  • Any supplement claims need to plainly describe how any named ingredients affect the structure or function of the human body

Barcode and Tracking

  • The Universal Product Code (UPC) needs to be featured. It identifies the item and allows it to be sold for retail in the United States
  • The Food Traceability List (FTL) ensures that all information relevant to the product’s supply chain needs to be provided

Compliance Strategies for Businesses

The regulations and rules are free and available for all to see, but they can be difficult to interpret and understand for those who aren’t experts. Navigating compliance for the FDA, EFSA, or other regulatory bodies is almost like walking through a labeled minefield.

Thankfully, with some basic strategies, companies can make the right moves to keep their stick pack products on the shelves.

1. Conduct Regulatory Research

No FDA agency member is going to call when there’s an update to their rulings or regulations. That’s why it’s on the individual businesses to stay on top of those regulations to ensure their products are too. That includes using and checking every regulatory resource available to see what’s changing or what already changed. The only entity that’s going to monitor the regulations relevant to a business is, in fact, that business itself.

2. Quality Control Systems

Quality assurance is a major aspect of most businesses and it’s a huge concern for consumers around the world. Conduct regular audits or checks on systems and practices to ensure they remain up-to-date. Regulations can change, but so can processes that have been done the same way for years. Minute changes could impact products, labels, and more leading to trouble with various agencies. That’s why employee training needs to be implemented so that workers can be just as knowledgeable and aware of what standards need to be met.

3. Professional Guidance

Want expert advice? Hire legal experts! There are numerous companies that specialize in helping manufacturers navigate various regulations, and that includes those for stick pack products. Compliance consultants exist for a reason. If it seems like an entire degree is needed to interpret certain laws or regulations, then hire the kind of legal expert that has it.

4. Documentation and Record-Keeping

Not only do regulations need to be followed, but facilities and products typically have to pass various inspections. Keep detailed records of those inspections and document every possible instance. Whenever an issue occurs with a particular batch or manufacturing release, those documents could be crucial in case there’s a need for a recall or other extreme measures.

5. Technological Solutions

Processes should not be left to human interpretation or action. There’s a reason why so many companies have automated their processes and services. It’s more efficient and it can often include the kinds of software and programs that can monitor various systems. That means that businesses can catch problems before they arise thanks to compliance software they’ve added to their systems. This is especially relevant to processes that are entirely automated. When there’s no human involved to ensure compliance, software needs to be in place that does.

Common Pitfalls and How To Avoid Them

Lastly, there are extremely common issues that most stick pack manufacturers or companies are going to deal with. Some are more extreme than others, but it’s important to make sure that the relevant parties are aware of what they are so they can prevent any issues from arising down the road.

Overlooking Small Label Details

The consequences of minor issues aren’t minor, they could be catastrophic. Allergens are one of the most prominent issues when it comes to stick pack labeling and packaging. If ingredients aren’t clearly defined, fines and product seizures aren’t the biggest concern, it could literally lead to illnesses or even worse for unaware consumers.

Non-Compliant Health Claims

This is a major problem in the supplement world right now. Some companies believe they can claim their product has just about any benefit, but that’s not the case. There are permissible health claims and there are non-permissible health claims. Ensure everyone involved knows what can be claimed and what cannot.

Ignoring International Differences

While the EFSA may not have the enforcement measures of the FDA, it’s still an agency businesses will not want to cross. Instead of having those expensive stick pack shipments seized in a country regulated by the EU or another governing body, just do the work to ensure the products meet the relevant standards before they get there.

Inadequate Testing and Quality Assurance

Once again, the only entity that’s truly going to ensure a company lives up to its standards is the company itself. Add the necessary failsafe and procedures that keep products from being contaminated or impacted by various risks. Identify what testing or quality assurance needs to be taught and then teach and keep employees aware of them. That way there will be several levels of checks and balances to keep the stick pack products in line.

CATEGORIES: