Many in the industry have been waiting on word from the FDA in regards to new NDI/DSHEA regulations. Although this is not in stone yet, the draft guidance written by the fda is now able to be viewed(Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues), and will most likely be 100% permanent within the next 2 weeks.
Here are a few exerts everyone should be aware of:
An NDI = New Dietary Ingredient. So with the above in mind, we all can rest assured that companies won't have to file NDI's for every single ingredient as long as each ingredient in the product is proven to be DSHEA compliant and thus supplied within the food supply.1. Is a NDI Notification required for a dietary supplement containing a NDI if the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered?
No. Even though an ingredient that was used to make a conventional food before October 15, 1994 is a NDI (unless it was also marketed as a dietary ingredient before that date), a NDI notification is not required for a dietary supplement containing the NDI as long as the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered (21 U.S.C. 350b(a)(1)).
In short, this means that any extracts are gone unless they are pure food material. This would mean pure botanical ingredients(1:1 extracts) are still fine, but things that differ from the original plant source(10:1 extracts etc) would not be considered OK anymore.If I change the manufacturing process for a dietary ingredient that was marketed in the U.S. prior to October 15, 1994, and the changes alter the chemical composition or structure of the ingredient, does that make the ingredient a NDI?
Most likely. If the changes in your manufacturing process alter the chemical composition or structure of the ingredient, the resulting compound is probably a NDI and a notification to FDA would be required. For example, using a solvent to prepare an extract from a pre-DSHEA dietary ingredient creates a NDI because the final extract contains only a fractionated subset of the constituent substances in the original dietary ingredient. In addition, changes that alter the composition of materials used to make the ingredient, such as using a different part of a plant (e.g., using an extract of plant leaves where the root extract from the same plant is a pre-DSHEA dietary ingredient), would create a NDI.
So for everyone that enjoys using 100:1 LongJack, or 10:1 ...say bye bye.
So we're left with pure plant material and /ethanol water extracts(that do not change the chemical integrity of the original ingredient/plant).1. What processes for manufacturing a dietary ingredient from an article of food present in the food supply do not result in chemical alteration?
Minor loss of components, dehydration, lyophilization, milling, and formation of a tincture or a solution in water, a slurry, a powder, or a solid in suspension do not chemically alter an ingredient. Examples:
* Leaves or roots of a plant consumed as conventional food (e.g., broccoli or carrots) are dried and ground for sale in powder form.
* A tincture is made by soaking pears in aqueous ethanol. The mixture is then milled and dried into a powder that is placed in a capsule.
Say goodbye to any ingredients that use weird/rare extraction methods.
This gem states that even if "company A" received a NDI acceptance "for ingredient 1", "company b" must also put in an NDI for the same ingredient.1. If another manufacturer or distributor has already submitted a notification for a particular NDI, and I intend to market a dietary supplement containing the same NDI, should I also submit a NDI notification?
Yes. Section 413(a)(2) of the FD&C Act (21 U.S.C. 350b(a)(2)) makes clear that any dietary supplement that contains a NDI is deemed adulterated unless the manufacturer or distributor of the dietary ingredient or the dietary supplement submits a NDI notification at least 75 days before introducing it into interstate commerce. The statute places the obligation for submitting the notification on each manufacturer or distributor. The original notifier conducted its safety evaluation based on the characteristics and intended use of the specific product under review, including the composition and labeling of the dietary supplement that the notifier was proposing to market. Any other manufacturer or distributor who wishes to market its own dietary supplement containing the same NDI should submit a NDI notification to FDA explaining its own basis for concluding that this new product containing the NDI will "reasonably expected to be safe" under the conditions recommended or suggested in the new product's labeling. Manufacturing processes and specifications needed to establish the identity of a NDI are usually trade secrets that are not available in the NDI docket. It should be noted that the original notifier is under no obligation to share with other manufacturers and distributors any trade secrets or confidential commercial information that were part of the basis for a safety conclusion for the original notifier's product.
Bye bye small companies.
andddddd the true game changer...
1. Is a synthetic copy of a constituent or extract of an herb or other botanical a dietary ingredient?
No. A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a "constituent" of the botanical that qualifies as a dietary ingredient under section 201(ff)(1)(F) of the FD&C Act (21 U.S.C. 321(ff)(1)(F)). Similarly, a synthetic version of a botanical extract is not an "extract" of a botanical under section 201(ff)(1)(F) because it was not actually extracted from the botanical.
This is where things get interesting. According to this, synthetic variations of any dietary ingredient are non-dshea due to the fact that they never originated in the food supply. This is what had me worried last week.
Everyone should know what this means. This means ANY synthetic ingredients are gone due to the fact that they were never in the food supply(the chemical itself may be found in food, but the ingredients used to make the synthetic chemical never were...thus need an NDI.
This means no more stimulants of any kind for the most part, no more thyroid metabolites, no more anything really.
In before every product on the market is , caffeine, and vitamin c.
note: I could have mis-read/misinterpreted these. If you find that I made a mistake, please show me where I messed up