Food and Drug Administration (FDA) has certain regulations that need to be followed for drug or kratom vendors to get verified and legal.
These regulations must be necessarily met in order to function properly as well as legally.
What are these regulations and how can a Kratom vendor become FDA compliant? To find the answer let’s have a look at the article below.
What is FDA and how does it function?
It is a body that regulates food and drug administration. It keeps a check on the nutrient values of food as well as the beneficial effects and the adverse effects of a particular food or drug on the human health.
The three claims that are defined by the FDA regulations include; health claims, nutrient claims and structure/function claims.
What health claims can be used to make Kratom vendors FDA compliant?
Health claims correlate the relationship between a drug and the effects and risks it poses on the health condition of a person.
The 3 ways in which FDA determines which health claims can be used on drug labels include;
- NLEA: 1990 Nutrition Labeling and Education Act
- FDAMA: 1997 Food and Drug Administration Modernization Act
- Interim procedures for Qualified health claims in the labeling of Conventional human food and human dietary supplements
In the above-mentioned acts, the FDA basically allows a product (food, drug or dietary supplement) to be legal in the market after reviewing and evaluating it thoroughly to know that it doesn’t pose any risks to health.
These acts are carried after a health claim petition or on the self-initiative basis. If the FDA doesn’t approve of a supplement it issues an authorizing regulation.
If it approves, after collecting evidence supporting the health claim, then the agency issues a letter of enforcement discretion.
Examples of health claims that FDA regulates
- Optimum levels of calcium throughout life can reduce the risk of osteoporosis.
- Kratom may reduce chronic pain.
- In the case of Kratom, a health claim petition can be made that states something like ‘Kratom reduces the intensity of Opiate withdrawal symptoms’.Now since the scientific evidence is low, the FDA is responsible for finding credible evidence that supports the claim.
- If FDA finds the evidence, then it can issue a letter that outlines the circumstances under which it is intending to consider the employment of enforcement discretion for utilization of the claim in food labeling.
What type of structure/function claims can be used by Kratom vendors to make it FDA Compliant?
These claims describe the role of a supplement intended the affect the normal function and structure of the human body.
In Kratom’s case; Kratom enhances cognition. FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
According to the act manufacturers and distributors are not allowed to market a product that is adulterated or misbranded and FDA can take action against such distributors if adulterated products reach the market.
Keeping this in mind, in many parts of the world, Kratom isn’t sold legally and thus a black market is rising by the day.
This also means that the Kratom vendors can adulterate Kratom and sell it at higher prices.
What should a Kratom label contain?
- Product Information.
- Information for consumers: tips for Kratom users.
- Information for the industry.
- Reporting of an adverse event: reporting of a complaint or concern or problem-related to Kratom should be done by linking consumer with manufacturer or distributor.
- New dietary Ingredients notification process.
What are the Dos for a Kratom vendor?
- Do utilize cosmetic claims (“beautifies”, “improves”)
- Do refer to emotions (‘decreases irritability’)
- Do use words like ‘wellness’, ‘supports’, ‘maintains’.
- Do refer to general body parts including systems.
- Do use qualifiers like ‘mild’, ‘occasional’ to differentiate a temporary condition from the symptoms of the disease.
- Do use FDA disclaimer but only with structure/function claims. (FDA disclaimer: “These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent disease.”)
What are the Don’ts for a Kratom vendor?
- Don’t use words like treat, cures, repairs, acute, disease, chronic.
- Do not mention diseases like cancer, fibromyalgia, osteoarthritis.
- Don’t refer to symptoms like fever, coughing, sneezing.
- Don’t use disease claims.
- Don’t recommend any product to augment another drug.
- Don’t recommend a product as a substitution for another drug.
How to qualify for FDA compliance via labeling?
- Use labeling on the appropriate places on containers and packages i.e. front label panel or the PDP ( the portion of the package label that is most likely observed by the consumer at the time of purchase)
- The label should contain a statement of identity, the name of the product, net quantity.
- Use a type or print size that is prominent and easy to the road.
- Food label must contain the name and address of manufacturer, packer as well as distributor.
Street address of the manufacturer and the city, state, and the ZIP code should also be there.
Examples of disease claims that can be converted to structure/function claims
- Prevents diarrhea- Improves the gastrointestinal health by reducing motility.
- It fights symptoms like flu and cold- Kratom boosts the immune system.
- Fights insomnia- Kratom relieves sleeping disorders.
- Used for arthritis – Used for joint and muscle aches.
- Reduces stress – Evokes a sense of calmness ensued by relaxation.
- Helps in decreasing obesity – Helps in weight loss plan.
- Reduced symptoms of ADHD – Kratom enhances focus and increases attention span.
- Reduces symptoms of osteoporosis – Kratom helps in increasing bone health.
- For chronic fatigue – Kratom improves daytime mental alertness at mild doses.
- Relieves headaches – Kratom reduces head and neck tension.
Using the above-mentioned tips Kratom can become FDA compliant.
This will benefit all users as there will be proper check and balance and there won’t be any adulteration of Kratom and its products that usually happen when it is sold in black.