News

February 11, 2019 – FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

The FDA released the fact that it had issued warning and advisory letters to 17 companies which it has determined are making unsubstantiated claims about their supplement products’ abilities to treat or cure serious diseases such as Alzheimer’s, cancer and opioid addition.

“The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions. These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.” 

The complete FDA Statement can be viewed here.

Of course, Geneaire, Inc. is not a recipient of an FDA letter, and Geneaire ReBuilder was not one of the products mentioned in any of the FDA letters.

Geneaire ReBuilder™ is a safe product, made in the USA entirely from FDA GRAS List compounds, and is therefore suitable for long term daily use. It is the result of over 30 years of accredited scientific research and medical trials and is a supplement focused on mitigating the neurological effects of aging.  It is not marketed as a cure for any specific disease.

Geneaire, Inc. is therefore fully supportive of the FDA’s new policy initiatives, which we see as essential for the ongoing oversight of the rapidly growing supplement Industry. We encourage all consumers to research any supplement they may consider purchasing and to consult with their physician.

February 11, 2019 Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

The FDA announced a new policy plan for the regulation of dietary supplements. The FDA’s priorities, as defined in the Statement, are:

  1. Ensuring public safety – protecting consumers from harmful products and/or ingredients
  2. Ensuring product integrity – making sure products contain the ingredients that they are labeled to contain, and manufactured to consistent quality standards
  3. To enable informed decision making – fostering an environment where consumers and healthcare professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.

To achieve these goals, Commissioner Scott Gottlieb announced his intention to introduce a number of new policies and communication tools, including a new rapid-response alert system so consumers can avoid buying or using products with harmful ingredients, and to notify responsible industry participants to avoid making or selling them.

The complete FDA Announcement van be viewed here.

Geneaire ReBuilder™ is a complex, precise formulation of multiple ingredients, all taken from the FDA’s published GRAS List compounds (Generally Recognized As Safe).

  • Our product is manufactured in the United States to the highest safety standards.
  • Unlike many manufacturers, our formulation is based on over 30 years of published scientific research and medical trials, conducted by renowned institutions
  • That research is readily available to consumers and medical professionals

Geneaire ReBuilder™ is a safe product, suitable for long term daily use, with a focus on mitigating the neurological effects of aging.  It is not marketed as a cure for any specific disease.

Geneaire, Inc. is therefore fully supportive of the FDA’s new policy initiatives, which we see as essential for the ongoing oversight of the rapidly growing supplement Industry. We encourage all consumers to research any supplement they may consider purchasing and to consult with their physician.

December, 2018 – South Coast Magazine publishes major feature about Geneaire ReBuilder™

The online version can be viewed here.

October, 2018 – Geneaire, Inc. announces general availability of Geneaire ReBuilder™ on Amazon

The price is $59.95 for a bottle of  60 capsules – a cost of $2 per day.  Click here to go straight to the ordering page…

September, 2018 – The Journal of Clinical Medicine and Therapeutics publishes result of Clinical Study performed at Hoag Hospital

The full clinical study entitled: Botanical Mixture Stabilizes Cognitive Function in Patients with Mild and Moderate Alzheimer’s Disease can be downloaded here.

June, 2018 – Geneaire, Inc. is granted exclusive licensing to provide product based on the research and formulas from Genescient, Inc.