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<\/a><\/figure><\/div>\n\n\n\nFDA Regulations: Health & Structure\/Function Claims<\/h2>\n\n\n\n
Let\u2019s begin by talking about the various regulations that are in place. These regulations affect any company that creates a product in the affected categories. The two many types of regulation that we need to think about today are health and structure\/function claims. <\/p>\n\n\n\n
Health Claims<\/h3>\n\n\n\n
The only claims that the FDA requires pre-approval for are health claims.
<\/p>\n\n\n\n
A health claim must include two specific components: <\/p>\n\n\n\n
- 1. A substance (food or food component)<\/li>
- 2. A disease or health-related condition<\/li><\/ol>\n\n\n\n
<\/p>\n\n\n\n
Any claim that contains both of these items can be called a health claim. If a claim does not contain both of these things, then it does not fall into the category of what needs to be regulated.
<\/p>\n\n\n\nLet\u2019s talk about an example.
<\/p>\n\n\n\nA package says that eating more fruit and vegetables promotes better digestion. This would not be considered to be a health claim because there is no specific health-related condition. It also does not talk about a specific food and instead talks about a category of food. Instead, it would be considered to be dietary guidance.
<\/p>\n\n\n\nStructure\/Function Claims<\/h3>\n\n\n\n
Another type of claims that we should discuss are what we call structure\/function claims. These claims talk about how a specific nutrient or ingredient affects the normal function of the body. Rather than claiming that the substance cures a disease, this type of claim instead talks about how the general well-being of the body can be improved.
<\/p>\n\n\n\nFor example, saying that \u201ccalcium builds strong bones\u201d is a structure\/function claim.
<\/p>\n\n\n\nWhen adding a structure\/function claim to a product in the US, the FDA does not need to regulate what it says. As long as you have substantial evidence that the claim is true, you are permitted to write about it. Then, you must notify the FDA within 30 days of marketing the product.
<\/p>\n\n\n\nThe final important aspect of this type of claim is that packaging must clearly indicate that the FDA did not evaluate the claims made. This disclaimer is required, or the FDA could order the product to be pulled from the shelves.<\/p>\n\n\n\n
<\/div>\n\n\n\nWhy Kratom Vendors Can\u2019t Use These<\/h2>\n\n\n\n
The problem with Kratom is that it is not FDA approved. Most vendors would say that it falls into the alternative health category, but that classification depends largely on how it is imported, sold, and marketed. <\/p>\n\n\n\n
Regardless of how Kratom is categorized, Kratom vendors are not legally able to use health claims or structure\/function claims.
<\/p>\n\n\n\nLet\u2019s break down why that is.
<\/p>\n\n\n\nFirst, health claims are not valid for Kratom.<\/strong><\/p>\n\n\n\n
There is not yet enough evidence supported by the FDA to prove that Kratom can treat any diseases, so there are no valid health claims that can be considered FDA approved and added to Kratom marketing.
<\/p>\n\n\n\nThere are unreliable Kratom vendors out there who regularly break these rules. They market their product with claims that they can cure cancer or opioid addiction disorders, but these types of health claims are not legal unless regulated by the FDA.
<\/p>\n\n\n\nAnd at this time, the FDA does not support any claims about Kratom, so we can\u2019t say much. This issue is the same in many industries where products and substances aren\u2019t fully vetted by the FDA. So, they cannot make particular claims.
<\/p>\n\n\n\nSecond, structure\/function claims are also not valid for Kratom.<\/strong><\/p>\n\n\n\n
There is not enough substantiated evidence in the eyes of the FDA to make any type of structure base claim. While mitragynine (the main active component in many types of Kratom) has effects on the body, it does not affect the base function level of your body.
<\/p>\n\n\n\nFor that reason, there is a lot that we as Kratom vendors cannot say about Kratom. We cannot legally make claims about much of what Kratom can and cannot do, and it will likely be some time before Kratom studies are further substantiated. <\/p>\n\n\n\n