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by Caerus
3509 days ago
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I don't think that applies here. According to the FDA Guidelines [1] (page 4) for a dietary supplement: "Furthermore, a dietary supplement must be labeled as a
dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a
sole item of a meal or of the diet" Soylent is clearly marketing it as a meal replacement which should disqualify it as a supplement. 1) https://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf |
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In either case, the essential standard is whether or not it's substantially similar to a product already on the market. The standard is "GRAS" or Generally Recognized As Safe. If you want to sell milk or vitamin C or whatever, you don't need to conduct your own safety studies since both have been sold for years without issue. You just have to ensure that your product is similar enough to the GRAS product to qualify.
I actually worked for an Algae Biofuels / Omega-3 company in the Bay Area for a period. The GRAS process wasn't onerous but was actually fairly regimented. We conducted uptake tests and enzyme tests on rats over several different period lengths to ensure that the algal omega-3s we were producing had the same impact as other sources of omega-3. Ours were a slightly different form (Ethyl Esters instead of Triglycerides) so our standard to meet was a little higher.
I was on the business side but have an undergrad science background if anyone has any questions.
EDIT:
Forgot to add a link to the GRAS status of the Algal Flour that Soylent is using:
http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/No...
They did a fair amount of safety testing to determine its status.
> In a published 90-day subchronic toxicity study, Hsd:Sprague Dawley rats, (n=10/sex/group) were fed diets of C. protothecoides S106 flour at up to approximately 4,800 mg/kg bw/d for males and 5,400 mg/kg bw/d for females; no adverse effects were observed. In a published 28-day study, Hsd:Sprague Dawley rats, (n=10/sex/group) were fed diets of C. protothecoides S106 flour at up to approximately 7,600 mg/kg bw/d for males and 8,100 mg/kg bw/d for females; no adverse effects were observed. The results of a published bacterial mutation study showed that algal flour (5000 microgram/plate) is neither genotoxic nor mutagenic. Additionally, a published study showed that algal flour did not induce a clastogenic response as evaluated by the bone marrow chromosomal aberration test in mice after a single oral dose (2000 mg/kg bw/d).