How Supplement Manufacture Perseveres
The supplement manufacture business faces unique marketing and manufacturing challenges as an alternative to medications yet has continued to grow and thrive.
If your “miracle” remedy was created with natural ingredients rather than prescribed pharmaceuticals, your product cannot claim to cure any ailment or your business will face lawsuits, jail time or worse. That is the brutal reality the natural cures industry has faced for decades against big pharma’s heavily lined pockets.
Pitched to protect consumers from harmful ingredients, the FDA began enforcing legislation to regulate supplements in 1994. Ironically, the FDA has failed to safeguard the public from many harmful pharmaceuticals over the years.
But those in the dietary supplement manufacturing business know not all nutraceutical products are created equally; some are highly beneficial while others are made with synthetic or diluted ingredients.
The Role of Dietary Supplements
As people have become increasingly aware of the harmful substances in the products they consume and the lack of nutrition offered by processed foods, they turn to supplements for the nutrients their diets sorely lack.
Dietary supplements come in a diverse array of types, each catering to various nutritional needs and health goals.
- Multivitamins and minerals are among the most common, offering a comprehensive blend of essential vitamins and minerals to support overall health.
- Herbal supplements utilize natural plant extracts, such as echinacea or ginseng, renowned for their potential health benefits.
- Specialty supplements like probiotics aid in gut health and digestive balance.
- Omega-3 fatty acids are popular for their heart and brain health advantages.
- Protein powders are favored among fitness enthusiasts for muscle recovery and growth.
- Additionally, there are supplements specifically designed for certain demographics, such as prenatal vitamins for pregnant individuals or calcium supplements for the elderly to support bone health.
The market offers a wide spectrum of dietary supplements tailored to meet specific nutritional requirements and health objectives. If you have a quality product your customers have come to love and you want to ensure consistent quality while meeting your profit margins, using a comprehensive manufacturing software like SOS Inventory can be vital tool that keeps your business operating profitably.
Supplement Manufacture vs. Pharmaceutical Manufacture
Supplement and pharmaceutical manufacturing differ significantly in terms of regulations, ingredients, research, and intended use.
Regulations and Oversight:
Pharmaceuticals: They are highly regulated by government agencies (like the FDA in the United States), which require extensive clinical trials and rigorous testing to prove safety, efficacy, and quality before they can be approved for market distribution.
Supplements: They are regulated differently. The regulations are generally less stringent compared to pharmaceuticals. For instance, in the United States, the FDA regulates dietary supplements under a different set of regulations compared to pharmaceutical drugs. Manufacturers don’t need to prove efficacy before marketing a dietary supplement and often list their ingredients as “proprietary.” They are responsible for ensuring the safety of their products.
Ingredients and Purpose:
Pharmaceuticals: They often contain synthetic compounds or highly purified active ingredients, carefully measured, and designed to treat, cure, or prevent specific medical conditions. The formulations are tightly controlled for consistency and efficacy.
Supplements: They contain vitamins, minerals, botanicals, amino acids, and other dietary ingredients. Supplements are not intended to treat, cure, or prevent diseases and cannot claim to do so. They are meant to supplement the diet and are not held to the same standard of efficacy or safety as pharmaceuticals.
Research and Development:
Pharmaceuticals: The development of pharmaceuticals involves extensive research, including preclinical studies, clinical trials (phases I to III), and post-marketing surveillance to ensure safety and effectiveness.
Supplements: Research on supplements varies widely. While some supplements have undergone rigorous scientific testing, others might not have undergone the same level of scrutiny or clinical trials as pharmaceuticals.
Quality Control and Production:
Pharmaceuticals: They must adhere to strict manufacturing processes, including Good Manufacturing Practices (GMP) to ensure consistency, quality, and purity. The facilities are regularly inspected to maintain high standards.
Supplements: Quality control can vary between manufacturers. While many reputable supplement companies follow GMP, the standards and enforcement can differ, potentially resulting in variations in quality and consistency between different brands.
Intended Use:
Pharmaceuticals: They are prescribed or recommended by healthcare professionals to treat, manage, or prevent specific medical conditions.
Supplements: They cannot claim to replace a varied diet or medication. They are often used to complement a person’s diet and lifestyle.
While on the surface supplement manufacturers have an easier time with regulations, they cannot reap the same benefits pharmaceutical companies do by making claims to benefits or cures.
DSHEA
The Dietary Supplement Health and Education Act (DSHEA) is a significant piece of legislation passed by the United States Congress in 1994. DSHEA was created to regulate dietary supplements and their ingredients.
Key features of the DSHEA include:
- Definition of Dietary Supplements: DSHEA defines dietary supplements as products intended to supplement the diet, which contain one or more dietary ingredients (such as vitamins, minerals, amino acids, herbs, or other botanicals) and are intended to be taken by mouth.
- Regulation of Ingredients: Under DSHEA, dietary supplements are not subject to the same rigorous testing for safety and efficacy as pharmaceutical drugs. Instead, manufacturers are responsible for ensuring the safety of their products before they are marketed. The FDA can act against any supplement found to be unsafe after it reaches the market.
- Labeling Requirements: DSHEA mandates specific labeling requirements for dietary supplements. Labels must include a list of all ingredients in the supplement, the quantity of the contents, and suggested usage. Additionally, the label cannot claim to treat, prevent, or cure diseases.
- New Dietary Ingredient Notification (NDIN): Manufacturers are required to notify the FDA about any new dietary ingredients that were not on the market before DSHEA was passed. This is to ensure that new ingredients are safe for consumption.
- Health Claims and Structure/Function Claims: DSHEA allows supplement manufacturers to make certain health claims, as long as they are backed by scientific evidence. These claims must be truthful and not misleading. However, claims that a supplement can cure, prevent, or treat a specific disease are not permitted.
DSHEA was intended to provide consumers with access to a broader range of dietary supplements while also ensuring their safety. However, it has also been subject to criticism. The act struck a balance between allowing access to supplements and providing a level of regulation without the extensive pre-market approval process required for pharmaceutical drugs.
Stay focused on your quality. Let SOS Inventory do the heavy lifting:
- To deliver quality supplements to their customers, manufacturers must adhere to formulas to ensure product remains consistent.
- From the time raw materials arrive at your door, SOS Inventory begins the tracking process allowing your team to record material quantities, costs, overhead, and labor every step of the way through production.
- Supplements require careful tracking and tracing – lot tracking features SOS Inventory is well-known for.
- Create a template for your formula using a bill of materials in fractional amounts – a key component of supplement manufacturing.
- Maintain accurate records of inventory quantities and costs for transparency, balanced books, and ease of access.
The process of supplement manufacturing involves several steps, from the initial formulation to the final packaging. While specific processes might vary based on the type of supplement and the manufacturer, here’s a general overview of the steps involved:
- Formulation Development: Research and development phase where the supplement’s formula is created. This includes determining the ingredients, their quantities, and the specific formulation for the supplement.
- Sourcing Raw Materials: Procuring raw materials such as vitamins, minerals, herbs, amino acids, and other ingredients from suppliers. These materials should meet quality standards and often require testing for purity and potency.
- Testing Raw Materials: Raw materials are typically subjected to testing to ensure they meet quality standards, which may include identity, purity, strength, and composition tests.
- Weighing and Mixing: The measured raw materials are combined and mixed according to the predetermined formulation. This mixing process is crucial to ensure a homogenous distribution of ingredients.
- Granulation or Compression: Depending on the supplement type (e.g., tablets or capsules), the mixture may be granulated to form uniform particles or compressed directly into tablets using specialized equipment.
- Encapsulation or Tableting: For supplements in the form of capsules, the encapsulation process involves filling and sealing measured quantities of the supplement mixture into gelatin or vegetarian capsules. For tablets, the compressed mixture is formed into the desired shape and size.
- Coating (optional): Some supplements, particularly tablets, may undergo a coating process for improved appearance, taste masking, or to control the release of ingredients in the body.
- Bottling or Packaging: Once the supplements are manufactured, they are packaged in bottles, blister packs, or other forms of packaging, and labeled with necessary information including ingredients, dosage, and directions for use.
- Quality Control and Testing: Throughout the entire process, quality control checks are implemented at various stages to ensure the supplements meet quality, purity, and potency standards. This includes in-process testing as well as final product testing.
- Storage and Distribution:
- After passing quality control checks, the finished supplements are stored under proper conditions to maintain their quality. They are then distributed to retailers, wholesalers, or directly to consumers.
- Regulatory Compliance:
- Manufacturers must comply with regulatory standards and may need to provide documentation and information to regulatory bodies to ensure the product complies with industry regulations and guidelines.
Each of these steps is critical to ensure the safety, efficacy, and quality of the final supplement product. Compliance with regulations and strict adherence to quality control measures are essential throughout the entire manufacturing process.
Into the Future of Supplement Manufacturing
Whether the FDA is effective in preventing harmful ingredients from reaching the public is debatable. Pharmaceutical companies set millions of dollars aside for each new product they manufacture to cover losses from lawsuits filed by harmed individuals, so clearly, they are aware their products can cause harm. While the strict guidelines deter supplement manufacturers from using dangerous ingredients, they also protect the pharmaceutical companies from losing profits to natural ingredient products.
It’s up to the consumer to seek an education about the benefits of alternative nutrition and medical benefits. The very best supplement customers are those that understand the benefit of natural ingredients over oil-based medications that come with many side effects.
Our culture has conditioned us to seek treatment for ailments rather than to practice prevention with proper nutrition. Most treatments and medications practiced by modern day practitioners are designed to treat symptoms, not cure problems. Greater transparency of the medical and pharmaceutical industry practices could potentially empower consumers to take greater responsibility for maintaining good health and avoiding the chemicals and poor nutrition that cause illnesses to begin with.
And this would result in an increase in market share for the dietary supplement manufacturing market moving into the future.
